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Mitsubishi Tanabe Pharma

Executive Summary

Mitsubishi Tanabe Pharma Corporation is a Japanese pharmaceuticals company, a subsidiary of Mitsubishi Chemical Holdings Corporation. It is a Japan-based company mainly engaged in the manufacture and sale of pharmaceutical products. The medical supplies business is engaged in the research, development, manufacture and sale of ethical pharmaceutical and non-prescription drugs. The Company’s subsidiaries receive raw materials from the company and sell products locally.

History of Mitsubishi Tanabe Pharma

Takeda Kasei Co., Ltd. was established in 1940 by Chobei Takeda & Co., Ltd. (present-day Takeda Pharmaceutical Company) and Nippon Kasei Chemical Co. Ltd. (present-day Mitsubishi Chemical Corporation) and built its first plant in Higashi-Yoshitomi-mura, Fukuoka Prefecture. The company changed its name in 1952 to Yoshitomi Pharmaceutical Co., Ltd. in 1946 and listed on Tokyo and Osaka stock exchanges in 1949.

The Blood Plasma Corporation of Japan was established in 1950 with head office and plant in Osaka. This company changed its name to Green Cross Corporation in 1964.

Green Cross Corporation was acquired by Yoshitomi Pharmaceutical in 1998, changing its name to Welfide Corporation in 2000. The founders of Green Cross Corporation included war criminals such as Kitano Masaji who performed torture and experimentations on humans in the Japanese military’s notorious Unit 731 during World War II. These crimes were recognized by the UN as extreme “crimes against humanity”.

In 1901 Motosaburo Tanabe established a pharmacy in Tokyo, which was incorporated in 1921 as Motosaburo Tanabe Shoten, changing its name in 1943 to Tokyo Tanabe Pharmaceuticals Co., Ltd.

Nippon Tar Industries was established in 1921, becoming Mitsubishi Chemical Industries, Ltd. in 1952. This company established a business alliance with Tokyo Tanabe Pharmaceuticals Co. in 1981, and changed its name to Mitsubishi Chemical Corporation following the 1984 merger with Mitsubishi Petrochemical Co., Ltd.

Mitsubishi Chemical Corporation and Tokyo Tanabe Pharmaceuticals Co. merged formally in 1999 and formed Mitsubishi-Tokyo Pharmaceuticals, Inc., to take over the combined pharmaceutical operations of the two companies.

Mitsubishi-Tokyo Pharmaceuticals and Welfide Corporation merged in 2001 to establish Mitsubishi Pharma Corporation, and this company joined again with Mitsubishi Chemical Corporation to create Mitsubishi Chemical Holdings Corporation in October 2005. In 2007, Mitsubishi Tanabe Pharma was born out of the merger between Tanabe Seiyaku and Mitsubishi Pharma.

In August 2014 the company announced it had agreed to collaborate with AstraZeneca to leverage the pair’s strengths, expertise and assets on diabetic nephropathy, in a bid to develop high quality drugs much quicker than working alone. According to the National Institute of Health, 60% to 70% of diabetic sufferers in the U.S. alone suffered from nerve disorders related to diabetic nephropathy. The three-year research agreement has the objective of creating new treatments to replace expensive and limited options currently in place, mainly being dialysis or kidney transplantation.

In July, 2017, the company acquired Neuroderm for $1.1 billion.

Subsidiaries of Mitsubishi Tanabe Pharma:

Among Mitsubishi Tanabe Pharma’s notable subsidiaries are:

  • Yoshitomiyakuhin Corporation – Japan
  • Mitsubishi Tanabe Pharma Factory Ltd. – Japan
  • Tanabe Seiyaku Yoshiki Factory Co., Ltd. – Japan
  • Mitsubishi Tanabe Pharma Holdings America, Inc. – USA 
  • MP Healthcare Venture Management Inc. – USA
  • Medicago Inc. – Canada
  • Tianjin Tanabe Seiyaku Co., Ltd. – Asia
  • NeuroDerm Ltd. – Europe

A full list of subsidiaries may be found here: https://www.mt-pharma.co.jp/e/ir/annual/pdf/CR_2018_en.pdf

Popular Pharmaceutical Products of Mitsubishi Tanabe Pharma

The top products of Mitsubishi Tanabe Pharma

  1. Remicade – Treatment of rheumatoid arthritis (RA), Crohn’s disease, psoriasis, ulcerative colitis, Behcet’s disease with refractory uveoretinitis, and ankylosing spondylitis
  2. Talion – Treatment of allergic disorders 
  3. Maintate – Treatment of hypertension, angina pectoris, extrasystole, chronic heart failure, and atrial fibrillation
  4. Kremezin – Treatment of chronic kidney disease
  5. Tetrabik – Combined vaccine for diphtheria, pertussis, tetanus, and polio
  6. Varicella vaccine – Freeze dried live attenuated varicella vaccine 

Product Recalls and Lawsuits

  1. In 2011, Mitsubish Tanabe Corp recalled two million of its injectable medicines made at a facility in Ashikaga, Japan, because it cannot guarantee their quality. The products that were affected were 5mcg and 10mcg formulations of the arteriosclerosis treatment Liple (alprostadil); 2.5mg doses of corticosteroid Limethason Intravenous Injection (dexamethasone palmitate) used to treat rheumatoid arthritis; and 300mg and 500mg doses of the quinolone antibiotic Pazucross Injection (pazufloxacin mesylate).

Litigation Settlements

As of 2019, Mitsubishi Tanabe has not been involved in any remarkable litigation settlements. 

Sources:

https://www.mt-pharma.co.jp/e/ir/annual/pdf/CR_2018_en.pdf

https://www.mt-pharma.co.jp/shared/show.php?url=/e/ir/annual/index.html

https://en.wikipedia.org/wiki/Mitsubishi_Tanabe_Pharma

http://www.pharmafile.com/news/280111/mitsubishi-tanabe-recalls-two-million-injectables

https://www.mt-pharma.co.jp/shared/show.php?url=/e/ir/annual/index.html

Allergan Pharmaceuticals

Executive summary

Allergan is a global pharmaceutical company which is located in Dublin Ireland and also its headquarters are located there. It is mainly focused on developing, manufacturing and distributing pharmaceutical, regenerative medicine products, surgical, biological products plus healthcare devices.

The markets quite a range of its own products and leading brands in many areas which includes; urology, women’s health, medical aesthetics and dermatology, gastroenterology, eye care and the central nervous system.

The company is an open science leader which has helped it so much in developing game changing ideas and innovations for the better and great care of the patients. It has over 100 operations globally and dedicated in working with healthcare providers and physicians in delivering meaningful and very innovative treatments to support and help people around the world to have healthier and longer lives.

Allergan pharmaceuticals in its operation, has received a share of litigations and lawsuits concerning its products. A lawsuit currently in place includes;

  • Los Angeles lawsuit against Seri Scaffold surgical mesh

In November 2016, a Los Angeles woman sued the company over its conspiracy with a doctor to promote the use of Seri Scaffold surgical mesh and Natrelle breast tissue in an experimental manner without her knowledge and consent. She sued the company for fraud, negligence and failure to warn her of the consequences and that Seri Scaffold surgical mesh did not receive clearance from FDA for use in breast cancer reconstruction. She is seeking punitive damages for the case. 

History of Allergan pharmaceuticals

Allergan was established in 1948 by Gavin S. Herbert a pharmacist and Dr. Parmis Khatibi. They created the first drug which was an allergy nose drop in Los Angeles and was marketed using the name Allergan. This eye drops then propelled the company to the eye care field from then henceforth.

The Allergan pharmaceuticals became a company in 1950 officially and it focused more on the eye care and eye care products by then being under private and became public in the year 1970. 

In 1980, the company merged with Smithkline Beckman which lasted for 9 years and in 1989, the two companies separated and which afterward was acquired by Smithkline Beecham.

Allergan has been involved in making major treatments falling under the umbrella of eye care, neuroscience and medical aesthetics. It has been involved in major acquisitions and expanding its base in the pharmaceutical industry globally.

Subsidiaries of Allergan pharmaceuticals

  1. Zeltiq Aesthetics

In March 2017, Allergan pharmaceuticals acquired Zeltiq aesthetics at a cost of $2.5 billion for complete acquire becoming part of Allergan family.

Zeltiq Aesthetics is a company which was established in 2005 and is located in California United States.

It is a science based company which deals with medical devices in developing the non-evasive procedures focusing mostly on reducing the unwanted body fat tissues.

  1. Envy Medical Inc.

This is the latest acquire of Allergan. It was acquired in March 2019 at an undisclosed fee. This company was established in 2002. It is a biotechnology company which provides dermatology plus medical aesthetics solutions.

The company is mostly involved in skin therapy which delivers in excellent skin health and appearance to address the issues of skin concerns. It has well perfected this area of skin therapy through Dermalinfusion which is the skin resurfacing treatment.

  1. Bonti

Allergan acquired Bonti in September at a cost of $195 million. The company was established in 2015. It was formerly called Endurance Biotech and changed this name to Bonti in 2015. It is a biotechnology company based in California United States.

  1. Elastagen

Elastagen is a company based in Sydney, New south Wales, Australia and was established in the year 2003. It was acquired by Allergan pharmaceuticals in February 2018 at a cost of $95 million.

This company focuses on treatment of the skin and offers solution to the skin care health. It is a medical company with products based on the human protein tropoelastin. Its technology platform has potentials in focusing many areas which includes; scar remodeling, skin rejuvenation and repair of tissues.

  1. Tobira Therapeutics

Tobira therapeutics is a company which is mostly engaged in the research and developing of compounds used for treating life threatening and very infectious diseases or ailments. It is located in New Jersey, United States. The company was established in 2006.

In September 2016, Tobira therapeutics was acquired by Allergan pharmaceuticals at a cost of $1.7 billion. This made the company to become whole subsidiary of Allergan.

The life threatening diseases which this company is involved are like HIV/AIDS, hepatitis and other infectious conditions.

  1. Chase pharmaceuticals

Chase pharmaceutical is a company which is focused in medical clinical developments of improved treatments for the central nervous system. It is located in Washington, United States. It was established in the year 2007.

It was acquired by Allergan pharmaceuticals in November 2016 at a cost of $125 million.

  1. Motus Therapeutics

Motus therapeutics is a company which is involved in the treatment of metabolic diseases. It is located in Boston, Massachusetts, United States and was established in 2008.

The company was acquired by Allergan pharmaceuticals in October 2016 at a cost of $200 million making it a whole subsidiary of Allergan pharmaceuticals.

  1. Forest Laboratories Holdings

In November 2014, Allergan pharmaceuticals acquired Forest Laboratories at accost of $66 billion. The company was established in 1992 and is based in Dublin Ireland.

This company focuses on developing, discovering and researching the therapeutics and pharmaceutical drugs for the unmet needs of patients all over the world.

Popular products of Allergan pharmaceuticals

  1. Celexa

Its generic name is Citalopram. 

It belongs to the class of antidepressant agents which is widely used in the treatment of depression symptoms. It is always used in the treatment of depression as indicated in the label and is not also limited to the treatment of post stroke behaviors, ethanol abuse and sexual dysfunction and in children used for OCD (Obsessive compulsive disorder).

  1. Botox

Its generic name is called Botulinum toxin type A.

It is used to treat neck pains and abnormal head position which are associated with cervical dystonia. Also used to temporarily treat the appearance of moderate frown lines between the eyebrows and treatment of excessive underarm sweating.

  1. Lexapro

Its generic name is Escitalopram.

It is mostly used for major depressive disorder (MDD) and generalized anxiety disorder (GAD).

  1. Viberzi

Its generic name is called Eluxadoline

It is used for the treatment of irritable bowel syndrome with diarrhea.

  1. Linzess

Its generic name is called Linaclotide

It is orally administered. It is used to treat irritable bowel syndrome with constipation and chronic constipation.

  1. Dalvance

The generic name for this product is Dalbavancin.

Dalvance for injection is used to treat adult patients with bacterial skin infections.

  1. Fetzima

The generic name for this product is called Levomilnacipran.

It is used in the treatment of major depressive disorder (MDD).

Product Recalls and Lawsuits

  1. Taytulla 2018 Recall

In May 2018, Allergan pharmaceuticals made a recall for Taytulla, a birth control pill. The reason for the recall was due to the packaging error which could result in one getting pregnant.

The four placebo capsules were placed out of order and this meant that patients could receive four non hormonal capsules for the first four days of the therapy instead of the active pink capsules which should be taken as one daily and the followed by four maroon capsules up to the end of the month.

After this recall, some lawsuits were filed against the company for damages caused after using the drug with the wrong instructions. 

  1. 2015 Refresh Lacri-Lube, Refresh P.M., FML, Blephamide Recall

Allergen Pharmaceuticals issued a voluntary recall in August 2015 of Refresh Lacri-Lube, Refresh P.M., FML, Blephamide due to potential contamination that could result to eye pain, swelling, irritation and ocular discomfort.

This recall was initiated by the company receiving complaints from customers of a small black particle contained in the drug which made the company to make this immediate and voluntary recall of the lots affected. This was in the interest of patient safety.

Litigation Settlements

  1. $600 Million Botox Settlement

In September 2010, Allergan pharmaceuticals paid $600 million in settlement of charges that it promoted and sold illegally it Botox drug from the year 2005 for unapproved uses.

The government trough a civil case alleged that the company with vigor and without thought of the negative effects health wise illegally promoted this drug Botox for uses that were not deemed safe by FDA.

The company developed and put a vigorous marketing strategy program and even included paying kickbacks to doctors who prescribed this drug for the unapproved uses.

Allergan agreed to pay $375 million to the government for one criminal charge it pleaded guilty to and $225 million to be submitted to Medicaid, Medicare and other government programs for civil charges of causing false claims.

  1. $313million  Celexa marketing claim Settlement 

In September 2010, Forest laboratories (now part of Allergan) the maker of Celexa paid $313 million to settle criminal and civil charges against it. It was alleged that the company drug for use in children for uses that were not yet approved by the FDA.

The company between the year 2000 and 2005 promoted and marketed the drug Celexa for uses which included cerebral palsy in children and headache instead the drug was approved for adult depression.

Sources:

https://www.allergan.com/about/company-profile

https://www.drugwatch.com/manufacturers/allergan/

https://www.nytimes.com/2010/09/16/health/16drug.html

https://www.crunchbase.com/organization/allergan/acquisitions/acquisitions_list#section-acquisitions

https://www.drugbank.ca/drugs/DB00083

 

Ranbaxy Laboratories

Executive Summary

Ranbaxy Laboratories Limited, India’s largest pharmaceutical company, is an integrated, research based, international pharmaceutical company, producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. The Company is ranked amongst the top ten global generic companies and has a presence in 23 of the top 25 pharma markets of the world. The Company with a global footprint in 49 countries, world-class manufacturing facilities in 11 and a diverse product portfolio, is rapidly moving towards global leadership, riding on its success in the world’s emerging and developed markets.

Ranbaxy Laboratories Ltd. officially ceased to exist as a company in 2014, when Sun Pharma acquired it. 

History of Ranbaxy

Ranbaxy was started by Ranbir Singh and Gurbax Singh in 1937 as a distributor for a Japanese company Shionogi. The name Ranbaxy is a portmanteau of the names of its first owners Ranbir and Gurbax. Bhai Mohan Singh bought the company in 1952 from his cousins Ranbir and Gurbax. After Bhai Mohan Singh’s son Parvinder Singh joined the company in 1967, the company saw an increase in scale.

In the late 1990s, Ranbaxy formed a US company, Ranbaxy Pharmaceuticals Inc., and to support its entry into the pharmaceutical market in United States.

In June 2008, Daiichi-Sankyo acquired a 34.8% stake in Ranbaxy from the family of CEO and Managing Director Malvinder Mohan Singh for USD 2.4 billion.

In November 2008, Daiichi-Sankyo completed the takeover of the company from the founding Singh family in a deal worth $4.6 billion by acquiring a 63.92% stake in Ranbaxy. Ranbaxy’s Malvinder Singh remained as CEO after the transaction. The addition of Ranbaxy Laboratories extended Daiichi-Sankyo’s operations, with the combined company worth about US$30 billion.

In 2009 it was reported that former Novartis Senior Vice-President Yugal Sikri would lead the India operations of Ranbaxy Laboratories.

In 2011, Ranbaxy Global Consumer Health Care received the OTC Company of the year award. In the 2012, 2013 and 2014 Brand Trust Reports, Ranbaxy was ranked 161st, 225th and 184th respectively among India’s most trusted brands.

On 7 April 2014 India based Sun Pharmaceutical and Japan based Daiichi Sankyo jointly announced the sale of the entire 63.4% share from Daiichi Sankyo to Sun Pharmaceutical in a $4 billion all-share deal. Under these agreements, shareholders of Ranbaxy, were to receive a 0.8 share of Sun Pharmaceutical for each share of Ranbaxy. After this acquisition, the partner Daiichi-Sankyo was to hold a stake of 9% in Sun Pharmaceutical.

Subsidiaries of Ranbaxy Labs:

As Sun Pharma has effectively acquired Ranbaxy Labs, its subsidiary companies are: 

  • Aditya Acquisition Company Ltd
  • Alkaloida Chemical Company Zrt
  • Alkaloida Sweden AB
  • AO Ranbaxy
  • Basics GmbH
  • Be-Tabs Investments proprietary Ltd
  • Faststone Mercantile Company Private Limited
  • Green Eco Development Centre Limited
  • Laboratories Ranbaxy S.L
  • Neetnav Real Estate Private Limited
  • Office Pharmaceutique Industries et Hospitalier SARL
  • OOO Sun Pharmaceutical Industries Ltd
  • Open Joint Stock Company BIOSINTEZ
  • Ranbaxy (Poland) Sp. Z o.O.
  • Ranbaxy (S.A.) (Proprietary) Ltd.
  • Ranbaxy (Thailand) Company Limited
  • Ranbaxy (U.K.) Limited
  • Ranbaxy Europe Limited
  • Ranbaxy Farmaceutica Ltda.
  • Ranbaxy Gmbh
  • Ranbaxy Holdings (U.K.) Limited
  • Ranbaxy Ireland Limited
  • Ranbaxy Italia S.P.A
  • Ranbaxy Nigeria Limited
  • Ranbaxy Pharma Proprietary Ltd
  • Ranbaxy Pharmaceuticals Canada Inc.
  • Ranbaxy Pharmaceuticals Ukraine LLC
  • Ranbaxy Pharmacie Generiques
  • Ranbaxy(Malaysia) Sdn Bhd
  • Realstone Multitrade Private Limited
  • Rexcel Egypt Company LLC
  • Skisen Labs Private Limited
  • Softdeal Trading Company Private Limited
  • SPIL DE Mexico S.A.de
  • Sun Farmaceutica Do Brasil Ltda
  • Sun Global Canada Pty Ltd
  • Sun Global Development FZE
  • Sun Laboratories FZE
  • Sun Pharma ANZ Pty Ltd
  • Sun Pharma De Mexico S.A.de
  • Sun Pharma De Venezuela, C.A
  • Sun Pharma East Africa Ltd
  • Sun Pharma Global FZE
  • Sun Pharma Healthcare FZE
  • Sun Pharma Holdings USA Inc and entities
  • Sun Pharma Holdings
  • Sun Pharma Industries SAC
  • Sun Pharma Japan Ltd
  • Sun Pharma Laboratories Limited
  • Sun Pharma (Netherlands) B.V.
  • Sun Pharma Phillipines Inc.
  • Sun Pharma SA Pty Ltd
  • Sun Pharma Switzerland Ltd.
  • Sun Pharmaceutical (Bangaldesh) Ltd
  • Sun Pharmaceutical Industries (Australia) Pty Ltd
  • Sun Pharmaceutical Industries (Europe) B.V.
  • Sun Pharmaceutical Peru SAC
  • Sun Pharmaceuticals France
  • Sun Pharmaceuticals Germany GmbH
  • Sun Pharmaceuticals Italia S.R.L.
  • Sun Pharmaceuticals Korea Ltd
  • Sun Pharmaceuticals Morocco Sarlau
  • Sun Pharmaceuticals UK Limited
  • Sunpharma Egypt LLC
  • Taro Pharmaceutical Industries Ltd
  • Terapia S.A.

Popular Pharmaceutical Products of Ranbaxy

The top products of Ranbaxy, with their therapeutic areas:

Abiraterone acetate* Anti-Cancer
Acamprosate Calcium CNS Stimulant
Acitretin Dermatology
Adapalene  Retinoid agent
Adefovir Dipivoxil AntiViral
Alendronate Sodium Anti-Osteoporosis
Amifostine Trihydrate* Radioprotective agent
Amisulpride Anti-Psychotic
Amorolfine Hydrochloride Dermatology
Amoxicillin Trihydrate Antiinfective
Anastrozole Anti-Cancer
Aripiprazole* Anti-Psychotic
Asenapine Maleate* Anti-Psychotic
Atazanavir Sulfate AntiViral
Atomoxetine HCl* ADHD Therapy
Atorvastatin Calcium Amorphous Cardiovascular
Atorvastatin Calcium Crystalline Cardiovascular
Atosiban Acetate Oxytocin Antagonist
Azacitidine Anti-Cancer
Benazepril Hydrochloride Cardiovascular
Bendamustine* Anti-Cancer
Bicalutamide Anti-Androgen
Bivalirudin* Anti-Coagulant
Bortezomib* Multiple Myeloma
Bosentan Monohydrate Cardiovascular
Budesonide Anti-Inlammatory Steroid
Buprenorphine HCl Analgesic
Bupropion HCl Anti-Depressant
Calcipotriol Anhydrous Psoriasis
Calcitonin (Salmon) Anti-Osteoporosis
Candesartan cilexetil Cardiovascular
Capecitabine Anti-Cancer
Carboplatin Anti-Cancer
Carvedilol Anti-Hypertensive
Cefaclor Antiinfective
Cefdinir Antiinfective
Cefpodoxime proxetil Antiinfective
Cefprozil Antiinfective
Cefuroxime Axetil Antibiotic
Celiprolol Hydrochloride Cardiovascular
Cephalexin Antiinfective
Cilastatin sodium sterile Antiinfective
Cilazapril Cardiovascular
Cinacalcet HCl* Calcimimetic
Ciprofloxacin Antiinfective
Ciprofloxacin Hydrochloride Antiinfective
Cisplatin Anti-Cancer
Citalopram Hydrobromide CNS
Clarithromycin Antiinfective
Clarithromycin Granules 27.5% Antiinfective
Clarithromycin Granules 43.75% Antiinfective
Clomipramine HCl Anti-Depressant
Clonazepam Anti-Epileptic
Clopidogrel Bisulphate Anti-Thrombotic
Clorazepate Dipotassium Anxiolytic
Colesevelam* Bile acid Sequestrant
Dabigatran Etexilate Mesylate* Anti-Coagulant
Decitabine Myelodysplastic Syndrome
Deferasirox* Iron Chelator
Desloratadine Anti-Histaminic
Desmopressin Acetate Vasopressin Analogue
Desvenlafaxine Fumarate Anti-Depressant
Divalproex Sodium Anti-Epileptic
Dobutamin HCl Cardiovascular
Donepezil HCl Anti-Alzheimer
Doripenem Antiinfective
Dothiepin HCl Anti-Depressant
Doxercalciferol* Hyperparathyroidism
Doxycycline Antiinfective
Doxycycline Hyclate Antiinfective
Dronedarone Anti-Arrhythmic
Drospirenone Oral Contraceptive
Duloxetine Anti-Depressant
Dydrogesterone Hormone Replacement Therapy
Edaravone Neuroprotective
Emtricitabine AntiViral
Entecavir AntiViral
Epinastine HCl Anti-Histaminic
Epinephrine Neurotransmitter
Epoprostenol Sodium Prostaglandin
Eptiibatide* Anti-Thrombotic
Escitalopram Oxalate Anti-Depressant
Esomeprazole Magnesium (Amorphous) Gastrointestinal
Esomeprazole Sodium Proton pump inhibitor
Eszopiclone Hypnotic
Exemestane Anti-Cancer
Exenatide * Anti-Diabetic
Febuxostat Form G Antigout
Fesoterodine Fumarate* Overactive bladder
Fexofenadine Hydrochloride Antihistamine
Finasteride Anti-Testosterone for BPH
Fingolimod Hydrochloride* Immuno modulator
Flupirtine Maleate Analgesic
Flurbiprofen NSAID
Fluticasone Propionate Anti-Allergic
Fluvastatin sodium Cardiovascular
Fluvoxamine Maleate Anti-Depressant
Fosamprenavir Calcium AntiViral
Fosinopril sodium Cardiovascular
Fosphenytoin Sodium Anti-Epileptic
Fulvestrant Anti-Cancer
Gabapentin Anti-Epileptic
Galantamine Hydrobromide CNS
Ganirelix Acetate* GnRH Antagonist
Gemcitabine HCl Anti-Cancer
Granisetron HCl Anti-Emetic
Ibandronate Sodium Anti-Osteoporosis
Imatinib Mesylate * Anti-Cancer
Imipenem Antiinfective
Irbesartan Cardiovascular
Irinotecan Anti-Cancer
Isotretinoin Dermatology
Lacosamide* Anti-Epileptic
Lamivudine AntiViral
Lansoprazole Gastrointestinal
Lenalidomide* Anti-Cancer
Lercanidipine HCl Anti-Hypertensive
Letrozole Anti-Cancer
Leuprolide Acetate Anti-Cancer
Levalbuterol HCl Anti-Asthmatic
Levalbuterol Tartrate* Anti- Asthmatic
Levetiracetam Anti-Epileptic
Levocetirizine di HCl Anti-Histaminic
Levofloxacin Antiinfective
Levosulpiride Anti-Psychotic
Linagliptin * Anti-Diabetic
Liothyronine Sodium Hormone Replacement Therapy
Lisinopril Cardiovascular
Lopinavir AntiViral
Loratadine Antihistaminic
Lorazepam CNS
Losartan Potassium Anti-Hypertensive
Loteprednol Etabonate Corticosteroid
Lubiprostone * Laxative
Lurasidone HCl Schizophrenia
Magnesium Valproate Anti-Epileptic
Meloxicam NSAID
Memantine HCl Anti-Alzheimer
Meropenem Antiinfective
Mesalazine/Mesalamine Anti-Inlammatory
Metadoxine Alcohol Abuse
Metformin HCl Anti-Diabetic
Methyl Phenidate HCl CNS Stimulant
Metoprolol Succinate Anti-Hypertensive
Metoprolol Tartrate Anti-Hypertensive
Midazolam CNS
Mifepristone Abortifacient
Milnacipran Hydrochloride CNS
Mirtazapine Hemihydrate Anti-Depressant
Montelukast Sodium Anti-Asthmatic
Naloxone HCl Opioid Antagonist
Naltrexone HCl Opioid Antagonist
Naratriptan HCl Anti-Migraine
Nevirapine AntiViral
Octreotide Acetate Anti-Cancer
Ofloxacin Antiinfective
Olanzapine Anti-Psychotic
Olopatadine HCl * Anti-Allergic
Omeprazole Magnesium CNS
Ondansetron Base Anti-Emetic
Ondansetron HCl Anti-Emetic
Orlistat Antiobesity
Oxaliplatin Anti-Cancer
Oxcarbazepine Anti-Epileptic
Oxetacaine Local-Anaesthetic
Paliperidone* Anti-Psychotic
Pamidronate Disodium Anti-Osteoporosis
Pantoprazole Sodium Sesquihydrate Proton pump inhibitor
Paroxetine HCl Anti-Depressant
Pemetrexed Disodium* Anti-Cancer
Pentazocine CNS
Pentoxifylline Anti-Anginal
Phentermine HCl Appetite Suppressant
Pioglitazone Hydrochloride Antidiabetic
Pramipexole Di HCl Anti-Parkinsons
Pramlintide Acetate Anti-Diabetic
Prasugrel Hydrochloride* Anti-Platelet
Pregabalin* Anti-Epileptic
Quetiapine Fumarate Anti-Psychotic
Quinapril Hydrochloride Cardiovascular
Rabeprazole sodium Gastrointestinal
Ramipril Cardiovascular
Ranitidine Hydrochloride Antihistaminic
Ranolazine Anti-Angina
Rasagiline Mesylate* Anti-Parkinsons
Repaglinide Antidiabetic
Rifaximin Anti-bacterial
Riluzole Amyotrophic lateral sclerosis
Risedronate Sodium Anti-Osteoporosis
Risperidone Anti-Psychotic
Ritonavir AntiViral
Rivastigmine Base Anti-Parkinsons
Rivastigmine Tartrate Anti-Parkinsons
Rizatriptan Benzoate Anti-Histamine
Rosuvastatin Calcium* Lipid lowering agent
Sertraline Hydrochloride Form I CNS
Sevelamer Carbonate* Hyperphosphatemia
Sevelamer HCl* Hyperphosphatemia
Simvastatin Cardiovascular
Sodium Valproate Anti-Epileptic
Solifenacin Succinate Antimuscarinic
Sumatriptan Succinate Anti-Migraine
Tadalafil Others
Tamsulosin Hydrochloride Urology
Telmisartan Cardiovascular
Temozolomide Anti-Cancer
Tenofovir Disoproxil fumarate AntiViral
Teriparatide Anti-Osteoporosis
Terlipressin Acetate Vasopressin Agent
Testosterone Cypionate Hormone Replacement Therapy
Tiagabine HCl Anti-Epileptic
Tizanidine HCl Muscle Relaxant
Tolterodine tartrate Antimuscarinic
Topiramate Anti-Epileptic
Tramadol HCl Opioid Analgesic
Valacyclovir Hydrochloride AntiViral
Valgancyclovir Hydrochloride (Amorphous Grade) AntiViral
Valgancyclovir Hydrochloride (Crystalline Grade) AntiViral
Valproic Acid Anti-Epileptic
Valsartan Cardiovascular
Venlafaxine Hydrochloride CNS
Voglibose Antidiabetic
Voriconazole Antifungal
Zoledronic Acid Anti-Osteoporosis
Zolmitriptan Anti-Migraine
Zolpidem Tartrate CNS
Zonisamide Anti-Epileptic

Product Recalls and Lawsuits

  1. In March 2015, Ranbaxy Laboratories Ltd was sued in a district court in the United States for allegedly manipulating U.S. Food and Drug Administration rules for years to keep rival generic drugs out of the market. The suit alleged that Ranbaxy filed “grossly inadequate” applications seeking approval for its drugs and deceived the FDA into granting approvals and giving the company market exclusivity. 
  2. In May 2013, Ranbaxy pleaded guilty to federal drug safety violations and paid $500 million in fines to resolve claims that it sold subpar drugs and made false statements to the Food and Drug Administration about its manufacturing practices at two factories in India.
  3. In 2012, Ranbaxy issued a voluntary retail-level recall for Atorvastatin calcium tablets (Lipitor) because it contained glass particles. Class action lawsuits were filed in New Jersey, United States. 
  4. In 2014, Ranbaxy issued a recall for Atorvastatin calcium after a pharmacist found a 20-milligram tablet in a sealed bottle marked for 10-milligram tablets, the U.S. Food and Drug Administration (FDA) said on its website.
  5. In 2015, Ranbaxy Laboratories Ltd. recalled nearly 30,000 packages of an allergy relief medication – loratadine and pseudoephedrine sulphate packages – that made its way to the United States in February. The U.S. Food and Drug Administration noted that the product was recalled as the result of defective packaging.
  6. In 2015, Ranbaxy’s parent company Sun Pharma voluntarily recalled 200 vials of its cancer drug, gemcitabine, in the United States. This was because of lack of assurance of sterility of the vials. 

Litigation Settlements

  1. In 2010, Ranbaxy Laboratories Limited and Ranbaxy USA agreed to settle a whistleblower lawsuit and will pay a record $500 million in fines and penalties. This is the largest financial penalty levied against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act. The violations revolve around safety violations that occurred at Ranbaxy USA, a subsidiary of the generic pharmaceutical manufacturer Ranbaxy Laboratories. They generic drug manufacturer is accused of allowing tainted drugs from two manufacturing facilities in India to be distributed within the United States market. As part of the settlement, Ranbaxy agreed to pay to a fine and forfeiture of $150 million, as well as an additional $350 million penalty to settle the civil claims that they submitted false statements to Medicaid, Medicare and other government healthcare programs. Approximately $49 million of the penalty will go to the whistleblower.
  2. In 2014, Ranbaxy Laboratories paid $39.75 million in tranches to the state of Texas in the U.S. to settle the litigation concerning its participation in the Texas Medicaid Program.
  3. In 2013, Ranbaxy paid around $420,000 to the U.S. state of Idaho as part of a $500-million settlement that the drug firm had signed with U.S. authorities.
  4. In 2017, Ranbaxy Laboratories agreed to settle lawsuits accusing it of accepting payments from pharmaceutical company Cephalon Inc to delay the release of a generic version of the latter’s wakefulness drug Provigil.
  5. In 2008, Ranbaxy settled with pharma giant AstraZeneca in an agreement that will keep Ranbaxy’s generic copies of the blockbuster heartburn drug Nexium off the U.S. market until 2014.
  6. In 2009, Ranbaxy Laboratories was been slapped with tough penalties by the US Food and Drug Administration (FDA) after it was repeatedly caught falsifying data from one of its four Indian manufacturing plants.

Sources:

https://www.cnbc.com/id/100261384

https://www.abrahamwatkins.com/blog/2012/11/ranbaxy-pharmaceuticals-drug-recall.shtml

https://www.nature.com/news/2009/090302/full/news.2009.130.html

https://www.wsj.com/articles/SB120824391214015579

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=878399

Watson Pharmaceuticals

Executive Summary

Watson pharmaceutical is a leading pharmaceutical company globally which is mainly engaged in developing, manufacturing, marketing and distribution of generic products. The company is located and headquartered in Corona, California, United States.

The company’s generic business is focused on the maintaining of the leading position in the US market where the company is currently ranked the third in annual prescriptions dispensation.

The company’s product portfolio is quite wide and ranges from hypertension, antibiotics, pain management, smoking and many other more.

The company’s global supply chain is ensuring that everyone is getting this great service from Watson pharmaceuticals because it is the duty of the company to offer value to the customers and patients for betterment of their lives.

The company has employed more than 7500 employees and they work together day and night to see the company core goals.

History of Watson Pharmaceuticals

Watson pharmaceutical was launched in the early 1980s when there was a great blooming market for the generic drugs. Generic drugs are mainly drugs that are usually off brand drugs but which are chemically the same as their main brand cousins.

Watson pharmaceutical was formed in 1985 and grew very significantly and in the 1990s, the company made key acquisitions and this expanded its base widely in the US market.

This company now operates as the fifth pharmaceutical company in the United States and it grows day in and out. It is much focused in ensuring that the market which is the consumers is reached with their unmet needs and a solution is offered to their medical and health needs.

Subsidiaries of Watson Pharmaceuticals

  1. Andrx Corporation

In April 2006, Watson pharmaceuticals acquired Andrx Corporation at a cost of $1.9 billion cash. The company was established in 1992 and is based in Davie, Florida United States.

This company mainly develops, manufacture and engages in the distribution and commercialization of the generic versions of controlled release pharmaceuticals and oral contraceptives and also in the release of immediate generic products. 

After this acquisition, the company was full acquired by Watson pharmaceuticals and became part of this family.

  1. Eden Biopharma Group

Watson pharmaceuticals acquired Eden biopharma group in January 2010 at a cost of $15 million in cash. This company was established in the year 2000 and it is located in Liverpool United Kingdom.

Eden biopharma group is a biopharmaceutical development consultancy which is focused in the provision of biopharmaceutical drug development and manufacturing services.

The company’s sole engagement is the product and process development, technical and regulatory support, strategic planning development, management outsourcing, technology transfers and in the coordination of clinical trial supplies

It always serves main pharmaceutical and biotechnology companies which are located in the United Kingdom, Australia, and Asia and in the entire Europe.

  1. Uteron Pharma

This is company which is committed to enabling research that is driven by the women’s needs. It develops women’s health products. 

The company offers Loveset which is a hormonal intra uterine device which in a consistent form releases very small quantities of levonorgestrel in the uterine cavity.

It also provides Diafert which is a non invasive adjunctive in vitro fertilization in the improvement of embryo selection during the assisted reproductive procedures.

The company was established in 2002 and is based in Grace-Hologne, Belgium.

Watson pharmaceuticals acquired Uteron pharma in January 2013 at a cost of $355 million which was $150 million in upfront cash and $155 million in future milestones.

  1. Schein Pharmaceuticals

Schein pharmaceutical is a pharmaceutical company that was established in 1993. The company develops, manufactures and does the marketing of generic products in the healthcare industry.

The company is located in Melville, New York, United States.

In May 2000, Watson pharmaceuticals acquired the Schein pharmaceutical at a cost of $674 million in cash basis to take it over which became a whole subsidiary of Watson pharmaceuticals.

Popular Products of Watson Pharmaceuticals

  1. Lipitor

Its generic name is called Atorvastatin.

It is used alongside with the diet to lower bad cholesterol and fats and raise good cholesterol in the blood. It belongs to the group of drugs which are called Statins. It works by reducing the amount of much cholesterol which is produced by the liver.

This lowering of bad cholesterol and increasing good cholesterol reduces much the risk of getting heart diseases and in the prevention of heart attacks and stroke.

Together with eating good diet, there are other lifestyle changes that may help too this drug in working better and achieving the required results such like; losing weight if overweight, stopping to smoke and doing a lot of exercises.

In using this drug Atorvastatin, follow the doctors’ prescriptions seriously and take this medicine directly by mouth with or without food.

Its side effects may include mild memory problems and sort of confusion with people taking this medicine

  1. Fentanyl

Its generic name is also called Fentinil.

This is the drug which is used as pain medication and under the opioid drugs. Opioid medications are the drugs that treat very severe pains where other medications have totally failed to work. 

It is a potent synthetic opioid excellent for controlling serious pain but which has also very huge abuse potential. This drug is also sometimes used as a recreational drug often mixed with heroin or cocaine.

This medication has short term effects which includes euphoria, relaxation and reduced feeling of pain. The side effects include vomiting, nausea, constipation, confusion, some weakness and sweating.

  1. Propafenone HCL

Its generic name is called Propafenone.

It is normally used to treat very serious and irregular human heartbeats. It is used to restore normal heart rhythm and also to maintain regular and steady heartbeat.

It normally works by blocking some activities of certain electrical signals in the heart which are likely to cause irregular heartbeats. It is highly recommended that you treat irregular heartbeats as if left unattended can cause blood clotting hence leading to the heart attacks or stroke.

This medication is usually taken by mouth and with or without food is okay. Always follow the doctor’s instructions as the dosage usually depends on the medical condition at hand hence it is only the doctor who can know how to prescribe.

The side effects of this drug mostly are dizziness, nausea, constipation, vomiting and anxiety.

Product Recalls and Lawsuits

  1. 2008 Fentanyl Drug Recall

In August 2008, Watson pharmaceuticals made a recall of Fentanyl patches. This recall was for one lot of Fentanyl transdermal system patches because there was a detection of Fentanyl patches gel leaking.

The exposure to the leaked Fentanyl gel could lead to possible overdose and respiratory depression. The Fentanyl transdermal system patches are mainly used in the management of persistent and moderate to severe chronic pain which require all time round the clock opioid administration. 

  1. 2009 Propafenone Recall

Watson pharmaceuticals made a voluntary recall of propafenone HCL tablets in March 2009. One lot of Propafenone HCL 225mgtablets which is in bottles and is mostly sold in the US is being recalled up to the level of the consumer.

The recalled tablets were manufactured by Watson pharmaceuticals and were being recalled because of oversized tablets. This is because some of them contained some higher ingredients than it is specified and this led to the oversize. 

The affected lots were distributed to the consumers between the dates of October 15, 2008 and November 26, 2008. No other lots were affected apart from these ones.

Propafenone is a product which is mainly used in the treatment of irregular heartbeats. It has a narrow therapeutic index and this affects patients who are very sensitive to very small variations and due to this, these tablets could have caused dose variations which in return will result in serious side effects. This is the reason why Watson recalled this up to the consumer level in order to minimize any risk that may be brought about.

Litigation Settlements

  1. $18 Million Elan’s Naproxen Sodium Litigation

In March 2006, Watson pharmaceuticals reached an agreement with Elan Corporation over patent litigation which was related to Watson’s Naproxen sodium commonly called Naprelan tablets.

Under the terms of this agreement, Watson paid Elan $18 million in full settlement of all disputes that emerged from Watson’s development, manufacture, and distribution of the drug Naprelan. 

The case was fully settled from that time and the two companies continued with their business as usual.

  1. $33 million Mississippi Litigation Settlement.

On January 2018, Watson pharmaceuticals agreed to pay $33 million to Mississippi over the alleged lawsuit that the company inflated prices of its drugs which were paid by the Mississippi federal state for the state Medicaid health insurance program.

It was alleged that the company defrauded the taxpayers of Mississippi by an estimated amount of over $7 million. This inflated prices varied from drug to drug and to some drugs the inflation went up to 1000%. Due to this the court awarded the federal state this amount of settlement. Under this settlement of $33 million, $8 million were compensatory damages to the Medicaid of Mississippi unit, $5 million as civil penalties and $20 million as punitive damages.

Sources:

https://www.crunchbase.com/organization/watson-pharmaceuticals#section-overview

https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=10965584

https://www.policymed.com/2018/02/watson-pharmaceuticals-now-part-of-teva-to-pay-33-million-to-mississippi.html

https://www.webmd.com/drugs/2/drug-841/atorvastatin-oral/details

Did Johnson and Johnson Recall Talc? 

Currently, Johnson’s Baby Powder is still sold on Amazon.com, which answers the question of whether or not Johnson and Johnson recall of talc has been recalled permanently. 

But what about temporary recall? Was there ever a Johnson and Johnson recall in 2017 or 2018? 

Surprising to many, the talcum powder used to powder baby’s bottoms never went through a Johnson and Johnson recall in 2017 or 2018 despite hundreds of lawsuits alleging that the company’s “gentle product” considered safe by moms nationwide actually contained dangerous levels of asbestos. 

According to the International Agency for Research on Cancer, and stated on the National Cancer Institute website, asbestos causes mesothelioma and cancers of the lung, ovary and larynx. 

Should Johnson and Johnson Recall Talc – After the Penalties?

One of these lawsuits against the company won and awarded $4.69 billion to 22 women. They claimed that the using Johnson & Johnson’s talcum products for several years – baby powder and Shower to Shower – caused ovarian cancer. 

Although 13.2 percent of this award went to compensate the victims (an average of $25 million per woman), the remainder of the amount was penalties to Johnson & Johnson. 

Yet Johnson & Johnson wouldn’t admit guilt. They reported that they stood behind their claims that its talc-based baby product is perfectly safe, does not contain asbestos, and use language to support this stance on their website. 

A Johnson and Johnson recall for talc doesn’t appear to be on the horizon in the future.

Additional lawsuits against the company for similar claims have resulted in verdicts that were originally awarded but then overturned in appeals courts. 

The medical studies seem to disagree with the statements from Johnson & Johnson in three major ways.

1. Talc is Inert and Safe

Johnson & Johnson states, “Talc is an “inert” ingredient, meaning it does not generate a chemical reaction when ingested or used on the skin” and that “People have taken advantage of its natural smoothness, safety and adsorbency since ancient Egyptian times.”

Scientists have rebutted this one point date back to 1999. That’s when University of São Paulo scientists studied what happened to talc once it got into the body in their study. 

The talc was delivered into the chest of 20 animals via a catheter. One to two days later,

talc crystals were found in every organ of all animals receiving the talc. The talc was absorbed rapidly through the lung surface. It didn’t matter how much talc was given; there was a rapid distribution of the talc into the body. This counters Johnson & Johnson’s claim that talc is inert, safe and chemically doesn’t react in the body. 

2. Talcum Powder is Pure

Another Johnson & Johnson’s website claim is that talcum powder is pure. It doesn’t contain asbestos. They also state, “The talc ore that meets our standards is then milled to a powder, tested for particle size and confirmed to meet Johnson & Johnson’s purity requirements.”

Again, the scientists don’t agree with these statements. Back in 1976, one of the first studies on cosmetic talcum powders analyzed what really was in talcum powder.

Twenty different types of cosmetic talcum powders were tested to determine their mineral and chemical composition. All of them were formulated prior to 1973. This is important because Johnson & Johnson’s talcum powder was sold on the market since the late 1800s. 

Ten of the samples tested contained detectable amounts of tremolite and anthophyllite, which contains asbestos, while some also contained fragmented forms of these minerals. The amounts ranged from tenths of a percent to over 14% by weight. Two of the samples contained chrysotile asbestos fiber. 

They were rarely the pure mineral talc – as Johnson and Johnson states – but instead were mixtures of various minerals. Only one of the five minerals was talc. The researchers commented on the possible adverse effects on health from the intermittent use of these products. 

Fast forward to the year 2015 where the Cosmetic Ingredient Review Expert Panel in Washington, D.C. assessed the use of talc in cosmetics. Industry specs state that cosmetic grade talc must contain no detectable fibrous, asbestos minerals. If so, it is safe and should not be applied to damaged skin. 

So why should moms be using baby powder on babies’ with diaper rashes? Is it time for a Johnson and Johnson recall on talc yet?

3. No Association Between Talc and Ovarian Cancer

Johnson & Johnson states on their website, “The National Cancer Institute’s Physician Data Query Editorial Board concluded that the weight of evidence does not support an association between perineal talc exposure and increased risk of ovarian cancer.”

Perhaps this was at one time, but new evidence has accumulated against this statement. Take a look. You decide if it’s time for a Johnson and Johnson recall on talc.

Use Talc Daily and Increase Your Risk of Cancer

Another study three years earlier from Columbia University in the OB/GYN department is further support against Johnsons & Johnson’s claim that talc is safe and doesn’t cause ovarian cancer.

Doctors removed the ovaries of 24 women and demonstrated talc had accumulated in the ovaries. They proved that talc can reach the upper genital tract if used for dusting the genitals or on sanitary pads. The more talcum powder you use, the greater your chances of developing ovarian cancer. 

How much evidence is needed to create the case? When should Johnson and Johnson recall talc?

Three Times More Cancer From Talc

In 2009 at the Keck School of Medicine. doctors found that the risk of developing ovarian cancer increased significantly with increasing frequency and duration of talc use compared to never users.  Their studies were population-based case control studies.  

Women who were talc users and had endometriosis showed a three-fold increased risk of ovarian cancer. 

Increase in Cancer in Postmenopausal Women

In 2010, doctors and researchers at Harvard and Brigham and Women’s Hospital in Boston together analyzed the association between invasive endometrial adenocarcinoma (ovarian cancer) in 599 cases of using women diagnosed between 1982 and 2004. 

A positive association was observed among postmenopausal women. Regular use of talcum powder (at least once a week) was associated with a 24% increase in risk. They concluded that perineal talcum powder use increases the risk of endometrial cancer, particularly among postmenopausal women. 

Very Specific Type of Ovarian Cancer Linked to Talc

This study totally goes against what Johnson & Johnson state on their website. 

In 2018, doctors at the Icahn School of Medicine at Mount Sinai in New York ran a meta-analysis of epidemiological studies on the link between talc powders and ovarian cancer. 

They found a statistically significant association between genital use of talc and ovarian cancer. The type of ovarian cancer that talc caused was serous carcinoma and related to how much talc the women used. High uses of talc correlated with high levels of ovarian cancer. 

Australian Scientists Confirm the Same Thing

In 2018, Australian doctors from the University of Sydney ran a meta-analysis to evaluate the use of talc and risk of ovarian cancer.

They found 24 case-control studies (13,421 cases) and 3 cohort studies (890 cases, 181,860 person-years) that met their strict requirements. Their analysis results were well defined:  any use of talc in the genitals was associated with increased risk of ovarian cancer. 

The cohort studies uncovered an association between talc use and invasive serous type ovarian cancer. 

Expect Changes in Public Awareness to Occur Rapidly

Over the last 10 years, every one of Johnson & Johnson’s assertions have been questioned by scientists in the U.S. as well as in other countries. 

And now they are moving into a whole new upgraded level of testing that proves the presence of genetic changes from talc, changes in normal cells of the ovaries, and changes in the overall environment of the reproductive tissues. This new level is verified with advanced testing methods such as electron microscopy, x-ray analysis and other methods. 

You Can’t Ignore Genetic Testing Results

In 2015, researchers from universities in Turkey showed the world they were ahead of the game in scientific methods to study the connection of talc and ovarian cancer. They studied what happens to genes when ovarian cells are exposed to talc. 

The results were not pretty. Their conclusion was that talcum powder was toxic to ovarian tissue in rats, affecting genes negatively.

It’s difficult to believe that Johnson & Johnson won’t recall talcum powder based on all this evidence. However, in the meantime, we each have to think for ourselves. One way to start the process is to consider talcum powder substitutes.

Talcum Powder Alternatives

What can you use if you want a talcum powder substitute and don’t want to take any risk whatsoever with your child or yourself? There are five alternatives you might want to check into. 

Two of these talcum powder alternatives have been studied; the others are natural talcum powder substitutes thought to be safe by moms focused n “natural healing” types of living habits.

1. Zinc Oxide Cream

In a Thai study, 50 infants between 5 and 12 months old were given talcum powder or the talcum powder substitute of zinc oxide cream daily on their bottom for diaper dermatitis for 8 weeks. 

Those in the zinc oxide group saw differences in dermatitis in 3.7 days as opposed to 2.7 days with the talc. This wasn’t that much of a difference and it didn’t give the talcum powder substitute a bad rap. 

Although the zinc oxide cream took longer to heal the dermatitis – 39 days as opposed to 19 days, the researchers calculated the hazards of using the talc to be 5.3 times greater risk than the zinc oxide. Overall, the scientists believe that zinc oxide cream is a suitable talcum powder substitute.

2. Corn Starch

Diaper dermatitis develops easily in babies because of extra moisture on the skin, increased pH of the skin (usually due to exposure to urine), and exposure to irritants from urine and feces. 

Barrier creams such as talcum powder have a role in preventing and treating diaper dermatitis. 

In one study, a corn starch product was used as a test to see if it would be effective as a talcum powder alternative in 52 diaper-wearing infants and toddlers. 

The corn starch product prevented about 70% of the test dye from reaching the skin surface, showing an ability to aid the skin barrier. There were no side effects and parents’ responses to the talcum powder substitute product were overwhelmingly positive. Pediatricians in the study declared the corn starch product safe and effective for helping prevent diaper dermatitis.

Researchers from an earlier study in 2000 at the Toxicology Program at the American Health Foundation in New York had good news to moms for corn starch as a talcum powder substitute. They concluded that when applied on baby’s bottoms (perineal application), corn starch shouldn’t be a risk factor for ovarian cancer. However, talcum powder was a potential causative factor in ovarian cancer.

And a study earlier, in 1984, showed that cornstarch and talc both minimized friction injuries on the skin. Both also could be counted on for keeping down the numbers of Candida yeast growth on the skin.

3. Oatmeal or Ground Oats

Natural healing advocates like taking rolled oats, grinding them, and then adding them to a hot bath – or a baby’s bottom. The oats on the baby’s bottom will soak up the excess moisture of the skin, provide some nutritive value to the skin along with healing properties, and decrease the inflammation that may be occurring from diaper rash. 

4. Slippery Elm Bark Herb Powder

Slippery elm bark powder is an herb that is called a demulcent. It’s gentle enough for babies to eat every day and calms down irritated tissues in the GI tract and other mucosal membranes of the body. 

Slippery elm is a suitable talcum powder alternative because moms have used on baby’s diaper rashes for hundreds of years. The herb is simply dusted on the baby’s buttocks and genital areas. It is not toxic in any way.

5. Marshmallow Root Herb Powder

Marshmallow root powder is also a demulcent, and frequently used as a substitute for slippery elm. Thus, it could also be dusted on a baby’s bottom and genitals and used as a talcum powder substitute. 

Sources:

Werebe, E.C., et al. Systemic distribution of talc after intrapleural administration in rats. Chest 1999 Jan;115(1):190-3. 

Heller, D.S., et al. The relationship between perineal cosmetic talc usage and ovarian talc particle burden. Am J Obstet Gynecol 1996 May;174(5):1507-10.

Rohl, A.N., et al. Consumer talcums and powders: mineral and chemical characterization. J Toxicol Environ Health 1976 Nov;2(2):255-84. 

Fiume, M.M., et al. Safety assessment of talc as used in cosmetics. Int J Toxicol 2015 Jul-Aug;34(1 Suppl):66S-129S. 

Heller, D.S., et al. The relationship between perineal cosmetic talc usage and ovarian talc particle burden. Am J Obstet Gynecol 1996 May;174(5):1507-10.

Wu, A.H., et al. markers of inflammation and risk of ovarian cancer in Los Angeles County. Int J Cancer 2009 mar 15;124(6):1409-15. 

Karageorgi, S., et al. Perineal use of talcum powder and endometrial cancer risk. Cancer Epidemiol Biomarkers Prev 2010 May; 19(5):1269-75

Berge, W., et al. Genital use of talc and risk of ovarian cancer: a meta-analysis. Eur J Cancer Prev 2018 May;27(3):248-257. 

Penninkilampi, R. and Eslick, G.D. Perineal talc use and ovarian cancer: a systematic review and analysis. Epidemiology 2018 Jan;29(1):41-49. 

Yumrutas, O., et al. Application of talcum powder, trichloroacetic acid, and silver nitrate in female rats for non-surgical sterilization: evaluation of the apoptotic pathway mRNA and miRNA genes. Int J Exp Pathol 2015 Apr; 96(2):111-5. 

Fletcher, N.M., et al. Molecular basis supporting the association of talcum powder use with increased risk of ovarian cancer. Reprod Sci 2019 Feb 28:1933719119831773. 

Girion, Lisa.  Johnson & Johnson knew for decades that asbestos lurked in its baby powder. A Reuters Investigation. Filed Dec. 14, 2018. Reuters Investigates. Powder Keg. Accessed online April 6, 2019. https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/ 

Asbestos Exposure and Cancer Risk. NIH National Cancer Institute. Accessed nline April 6, 2019. https://www.cancer.gov/about-cancer/causes-prevention/risk/substances/asbestos/asbestos-fact-sheet 

  1. Chaithirayanon, S. Comparative study between talcum and zinc oxide cream for the prevention of irritant contact diaper dermatitis in infants. J Med Assoc Thai 2016 Nov;99 Suppl 8:S1-S6. 
  2. Gunt, H.B., Levy, S.B., and Lutrario, C.A. A natural cream-to-powder formulation developed for the prevention of diaper dermatitis in diaper-wearing infants and children: Barrier property and in-use tolerance studies. J Drugs Dermatol 2018 May 1:17(5):566-570. 
  3. Whysner, J. and Mohan, N. Perineal application of talc and cornstarch powders: evaluation of ovarian cancer risk. Am J Obstet Gynecol 2000 Mar;182(3):720-34. 
  4. Leyden, J.J. Corn starch, Candida albicans, and diaper rash. Pediatr Dermatol 1984 Apr;1(4):322-5. 

Proton Pump Inhibitors Linked to Bone Fractures and Kidney Failure

Proton pump inhibitors (PPI’s) have an excellent safety profile and have become one of the most commonly prescribed class of drugs in primary and specialty care. Long-term, sometimes lifetime, use is becoming increasingly common, often without appropriate indications. This article is a short review of the current evidence on this important topic, focusing on the potential adverse effects of long-term proton pump inhibitor use that have generated the greatest concern. Some of the side effects are indicated below. 

They are: B12 deficiency; iron deficiency; hypomagnesemia; increased susceptibility to pneumonia, enteric infections, and fractures; hypergastrinemia and cancer; drug interactions; and birth defects.

The benefits of proton pump inhibitor use outweigh its risks in most patients. Elderly, malnourished, immune-compromised, chronically ill, and osteoporotic patients theoretically could be at increased risk from long-term therapy. Digestive Diseases and Sciences April 2011, Volume 56, Issue 4, pp 931–950

The average person may see the term Protein Pump Inhibitors (PPI’s) and think it is something from outer space, or that it is physics related. In layman’s terms it is quite simple. They reduce stomach acids.

Proton-pump inhibitors are a group of drugs whose main action is a pronounced and long-lasting reduction of stomach acid production. Within the class of medications, there is no clear evidence that one agent works better than another. (Google Scholar)

The Layman (Joe Q. Public) may not know what a PPI is, but with some degree of certainty the names will ring a bell. Some examples of proton pump inhibitors approved in the U.S. as provided by Medline Plus:

The most common side effects of proton pump inhibitors are:

Serious risks of PPI use may include:

  • Bone fracture
  • Acute kidney injury
  • Chronic kidney disease
  • Acute interstitial nephritis
  • Low magnesium levels
  • Heart attack
  • Stroke
  • Dementia

As a registered nurse of 28 years I took care of patients with the above serious illnesses. And never for a moment did I associate these illnesses with the usage of PPI’s. As a trained professional I knew of the general side effects. It must make you wonder what Joe Q. Public knows? 

Legal Actions Are Being Taken Against Proton Pump Inhibitors

The concern over serious complications associated with proton pump inhibitors has been brought on by a series of studies and reports that have been conducted on these drugs. A recent study published in the Journal of the American Society of Nephrology concluded that taking PPIs may dramatically increase the risk of kidney failure and kidney disease. 

 The study determined there was a significant difference in the rates of acute kidney injury and acute interstitial nephritis in patients who took PPIs compared to those who did not — the risk of end-stage renal disease was 96% higher in those who took PPIs.

Wow. I went into nursing for various reasons. One of them was that I was poor at mathematics. The risk of end stage renal disease is 96% higher in those who took PPI’s! As a patient there are 2 options when it comes to end stage renal disease (ESRD). Death or living your life surrounded by a renal dialysis machine. In my experience many people would prefer death.

PPIs and Bone Fractures

In May 2010, the U.S. Food & Drug Administration (FDA) announced it was revising the safety labeling for PPIs to warn that they might be associated with a higher risk of hip, wrist and spine factures. The new safety information was based on the FDA’s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with PPI use. 

What Specific Legal Action Has Been Taken Against Proton Pump Inhibitors?

 In the last few years, multiple lawsuits against PPI manufacturers have been settled for large amounts. In 2013, Nexium manufacturer AstraZeneca settled a lawsuit that alleged deceptive marketing tactics were used in promoting the product. The class action lawsuit settled for $20 million.

Then, in February 2015, AstraZeneca settled another lawsuit for $7.9 million against the United States Government alleging that the company engaged in a kickback scheme that was in violation of the False Claims Act.

Another PPI manufacturer, Teva Pharmaceuticals, settled a class action lawsuit for $24 million in June 2015. This lawsuit alleged that Teva intentionally withheld a generic version of Nexium off the market after it was found that they were paid off by AstraZeneca.

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It is important for those who have suffered injury from dangerous drugs and medical devices to know that they have may have options.

Consumers have the ability to seek legal remedies for their injuries resulting from the negligence of drug and device manufacturers. The first step toward justice and recovery is sharing your story with effective legal counsel. An attorney will help you to better understand the issues and discuss the possibility of compensation for your suffering.

Once you complete the information request above, Drug Law Journal will send the information to a specialist at our legal sponsor’s firm, the DDP Injury Law Group, in Washington, D.C. That specialist will follow-up with you directly to gather further specific information about your case and make an evaluation. If the firm is able to move forward on your case, they will also discuss next steps. Remember – the entire consult and evaluation is free to you. You only need to take the first step to fill out the contact form or call: (800) 597-1870 for immediate assistance.