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Updated Guidelines For Treatment of Adolescent ADHD

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The American Academy of Pediatrics (AAP) has revised the guidelines for the care of children and adolescents diagnosed with attention-deficit/hyperactivity disorder (ADHD) which offers clinicians updated information and opportunities as they work towards providing treatment plans for patients in their care.

Caring for patients with ADHD is complex, and according to the updated treatment models, occurs best in a patient-centered medical home. These new guidelines have been updated from 2011, and can serve as sources of current applications and information for primary care pediatricians, nurse practitioners, physician assistants, and family medicine practices.

Establishing the diagnosis, these guidelines are based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).  While the DSM-5 guidelines are similar to those of 2011, there are two noteworthy exceptions.  Fewer problem behaviors for those age 17 and over are required, and evidence that symptoms began before the age of 12 years instead of age 7.

Also remaining essentially unchanged are the recommended courses of treatments for ADHD. Stimulant medications amphetamines and methylphenidate in various forms are typically the initial approach to counteracting the symptoms of this disorder. Additions included an increase in the number of extended-release forms of stimulant medications, such as Atomexetine, which remains a secondary alternative medication.

Alpha-2 agonists guanfacine and clonidine also continue to be preferred methods of secondary alternative medications.  These extended-release medications are also approved by the Food and Drug Administration as adjuvant treatments.

While behavior therapy is recommended as the first line treatment approach for preschoolers, it is noted in the new guidelines that descriptions of ‘behavior therapy’ for children remain vague, and more detailed treatment plans should be identified.

The predominant studies that were reviewed included recommendations for parents and caregivers that describe behavior management tactics for preschoolers diagnosed with ADHD. Valuing parent and teacher training in behavior management for high school aged children, several included studies outlined the importance of a continuum of care.

Additional concerns touch on the challenges that can be experienced by clinicians when seeking to implement these guidelines, including poor paediatric training in mental health, limited consultative services, and barriers to communication with schools.

The Drug Law Journal provides a wealth of information on updates to medical and mental health guidelines, pertinent information on drug recalls and lawsuits, and current treatment approaches for ADHD diagnosis as well as other health related topics. Staying informed and updated on current findings is an important piece of ensuring the best care is received.

Understanding Drug Recalls

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Whether or not you have a health condition that requires ongoing prescription medication use, or you are someone who rarely uses medication, it is important to know and understand if and how medication is recalled. It is important to be vigilant when using prescription drugs in order to ensure what you are taking is safe as well as effective.

The U.S. Food and Drug Administration (FDA) is the branch of the federal government that oversees the regulation and safety of prescription and over-the-counter medication, in addition to its other charges.  If a certain product under its jurisdiction is contaminated, defective, or poses otherwise potential negative health implications, the FDA may issue a public recall of that item.

Recalls are categorized by the FDA into three different classifications, and understanding these classifications is important when determining how a recall may affect you. In a Class I Recall, significant and immediate danger, serious injury, or death has been determined to be caused by the use of the product. 

Even those Class I recalls are rare, they should be obeyed as soon as you become aware of the situation.  In this event, the FDA will develop a plan for the manufacturer and the product involved to make sure compliance with the recall is trackable and complete.  Under these serious circumstances, the objective is to remove all of the affected items from the market as well as from people’s homes to ensure no further damage takes place.

If a Class II Recall is issued by the FDA, there is no immediate danger, serious injury, or death linked to the product, but the risk is still present.  Class II recalls are preventative in nature, once health and safety risks are involved and have been determined to be possible.  In this scenario, the FDA will work with the manufacturer to distribute information about the recall to the consumers, in addition to creating a plan to make sure all items are pulled from the market.

In the final category of Class III, recalls are issued where there is no immediate or perceived danger to health, but where items that have been released are in violation of FDA regulations.  This circumstance can happen when medications that are potentially contaminated during manufacturing continue to market against regulation.

There are times when medications or medical products make it to market and cause harm before problems have been detected by the FDA.  The best practice to ensure that the products you are using are safe, and remain safe, to use, is to check with the Drug Law Journal to see listings of product recalls and advisory information.  The Drug Law Journal is a comprehensive and up to date resource for medical and health related news and law.  Understand how your medications affect you and your rights if what you are prescribed is recalled.

Keeping Up To Date On Potential Dangers of Medications

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Chances are you have taken medicine in the last six months.  Over the counter medications are taken by four out of five adults while prescription drugs are used by almost half of American Adults, according to the Centers for Disease Control.  Drug companies continue to produce new medications that, for the most part, weave seamlessly into the industry causing little stir.

However, there are potentially dangerous consequences for going blindly into using any medication, regardless of it being prescribed or over the counter. Fortunately, it is easier than ever to learn about medications before we take, or continue to take them. 

Speaking with your doctor before taking any over the counter medications, including pain relievers, allergy medicines, and even nutritional and vitamin supplements, is the first and best measure to take before introducing any medication into your body.  This is especially important for people who have a history of kidney or heart disease, or who take blood thinning medications. 

Many supplements and over the counter drugs can react badly with existing prescription drugs or have the dangerous effect of making important prescription medications less effective than they should be.  Even taking too much of a seemingly harmless medication or supplement can pose a serious threat, even to an otherwise healthy person.

If you have questions, speaking to a pharmacist can also be an easy and quick way to find out what you need to know when it comes to any medication or supplement.  Most stores that carrie medications have in house pharmacists that can be helpful, and if that is not the case, local pharmacists in your community are more than happy to address any questions or concerns that you may have when it comes to drug safety and drug interactions.

It is always a good idea to check the safety of a drug or medication that you are about to take, or may already be taking.  Many times certain medications are deemed harmful, even after years of extended production and use.  Checking with the Drug Law Journal website is the most effective way to seek continued up to date information on drugs that are considered harmful or ineffective.

This site makes it easy to find out current information on your medication and up to date breaking information on drug recalls.  The Drug Law Journal also contains studies and articles on various topics relating to medications that can be useful when determining what you may need to address with your doctor or pharmacist.

It is worth remembering that you are your best advocate when it comes to your health.  Keeping up to date on prescription drugs and over the counter medication safety may seem to be something that you hope to delegate solely to your physician, but it is wise to take an active role in understanding what you are taking into your body.

Wellness and Aging

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Living a healthy life is what makes a person feel better. One of the biggest challenges that everyone faces is adding more years to their life. According to the research associates, 12 out of 100 people in the U.S are aged 65 or older. These elder members of your house often fail to cope with the changes that come to their way of living. Well, the three most important things that can only make you feel happier with aging and are – exercise, diet, and sleep. As the phrase says “prevention is better than cure”, one must start following the tips from early aging that can gift them a healthier and happier lifestyle in the future.

Once you start maintaining a proper lifestyle, it will help you to skip the chronic diseases and bless you with a long-living livelihood. Exercise and diet are no doubt the counter stones of living a better life for senior people. If you start participating in exercise regularly, then you can find a noticeable impact on well-being. Some health issues for both men and women like – arthritis, high blood pressure, osteoporosis, dementia, high cholesterol, and depression can be avoided. The research estimates, 1 in 4 Americans suffers from the above diseases. And these chronic conditions of your body may affect your independence and daily active lifestyle as well.

Hence, the well-being of a senior person must not be over-emphasized. You can follow the steps below to win over fatal diseases.

What are the basics of staying healthy?

The following tips can make your body stronger and engage it with a good immune system that can help you fight against the uncertain disease. 

Diet and nutrition:

Choosing proper diet food is important! You can notice some significant changes in your body when you are in your 60’s, 70’s or 80’s. Heart and lung disease, diabetes mellitus, stroke, cancer, and memory deficit etc are said to be the impact of the food that you consume.

A balanced diet that is comprised of whole grains, fruits, fibre and vegetables can help your body to receive a proportionate amount of carbohydrate, vitamin, protein, and mineral elements. The portion of food you intake is also important as it allows your body to maintain the metabolic needs. 

A healthy diet arms your body with energy sufficiency that you need while ageing. And if you find absolutely nothing abnormal in your health, then you are likely following the right guidance in terms of consuming food.

Drinking Lots of Liquids

People towards aging start losing the sense of thirst which develops urinary infections in their body. To help your body staying well-hydrated start the habit of drinking more water. On the hot days, you should intake water both before and after you are done with your exercise. Liquids that have a lower amount of sodium, fat and sugar must be consumed. Some of the good choices are – low-fat soups, skim milk, water, fruit juices (say cranberry, orange and apple). One must avoid the food that comes up with empty calories such as – alcohol, sodas, doughnuts, and cookies etc.

What to eat?

To install the anti-inflammatory immune system, you must intake a rainbow of brightly coloured food. It will let your body having the nutrients that it requires. Fruits and veggies like – tomato, watermelon, grapefruit, spinach, sweet potato, peach, broccoli, and cabbage and many others should be consumed.

What are there in healthy protein meals?

Some of the healthy meals include –

  • Fruits and vegetables (red, orange, green, purple, and blue)
  • Low-fat dairy (low-fat cheese and skim milk)
  • Lean protein (chicken, eggs, lean meat, seafood, pork, and legumes)
  • Whole grains (wild rice, oatmeal, and whole heat toast)

Moreover, foods that are high in Vitamin D must be incorporated in your diet chart.

How much to eat?

People who don’t care about the proportion may face health issues. Everything in your diet chart must be proportionate. People who are in their 50’s or older may check the following food habit each day.

  • Vegetables—2 to 3½ cups
  • Protein foods—5 to 7 ounces
  • Oils—5 to 8 teaspoons
  • Fruits—1½ to 2½ cups
  • Grains—5 to 10 ounces
  • Dairy foods—3 cups of fat-free or low-fat milk
  • Sodium (salt) and solid fats and added sugars (SoFAS) — less amount

Regular Exercise

Everyone must involve their body with a regular physical activity so that they can keep their nerves energetic and healthy. For seniors, it will help them skipping hypertension, osteoporosis, heart disease, and diabetes etc.

A minimum of 30 minutes of exercise increases the heart rate by about 75%. If you want to avoid hard exercising techniques, then take a 30 minutes’ walk to the garden every day. Set a lower target to achieve your walking distance. Also, you can do some machine exercise to bring flexibility in your body (avoid weight lifting without professional’s help). 

A daily exercise may be beneficial in the following ways –

  1. Maintaining proper weight as per the height and age
  2. Good cholesterol level
  3. Delivering oxygen and nutrients to tissues
  4. Increasing physical energy
  5. Excellent sleep and mood-enhancing
  6. Reducing injuries and falls

Sleep and aging:

Older adults who are aged 50-65 must have 7-9 hours of sleep every night. Those who are 65+ should adopt a sleeping habit of 7-8 hours a day. However, waking up a maximum number of times throughout the night may result in sleep deprivation. But remember, poor sleep may affect your mental as well as physical well-being. It can also give rise to some diseases like – obesity, hypertension, mood disorder, and shortened life expectancy, etc.

If you are facing difficulty to have a good sleep at night, then you can follow the tips mentioned below.

  • Avoid consuming more caffeine throughout the day. Also, you should not intake alcohol at an alarming rate.
  • Take a light snack or supper before going to bed at night.
  • Drinking too much before bed may encourage you to go to pee at night. So, avoid drinking too much liquid before going to bed.
  • Also, avoid napping too late in the day.

GlaxoSmithKline (GSK)

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Executive Summary

GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical company headquartered in Brentford, London. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham, GSK was the world’s sixth largest pharmaceutical company as of 2015, after Pfizer, Novartis, Merck, Hoffmann-La Roche and Sanofi.

GSK’s drugs and vaccines earned revenue of £21.3 billion in 2013. Its top-selling products that year were Advair, Avodart, Flovent, Augmentin, Lovaza and Lamictal. GSK’s consumer products, which earned revenue of £5.2 billion in 2013, include Sensodyne and Aquafresh toothpaste, the malted-milk drink Horlicks, Abreva for cold sores, Breathe Right nasal strips, Nicoderm and Nicorette nicotine replacements, and Night Nurse, a cold remedy. The company developed the first malaria vaccine, RTS,S, which it said in 2014 it would make available for five percent above cost. Legacy products developed at GSK include several listed in the World Health Organization Model List of Essential Medicines, such as amoxicillin, mercaptopurine, pyrimethamine and zidovudine.

History of GSK

GlaxoSmithKline was born out of a merger between Glaxo Wellcome and SmithKline Beecham in January 2000. The merger was completed in December that year. The company’s global headquarters are at GSK House, Brentford, London, officially opened in 2002 by then-Prime Minister Tony Blair. The building was erected at a cost of £300 million.

A year later, GSK acquired US-based Block Drug Co. (the company which formed from Alexander Block’s US drugstore), adding to its portfolio a wider range of consumer products, including Sensodyne toothpaste. In 2009, the company acquired Stiefel Laboratories, which was then the world’s largest independent dermatology drug company, enabling GSK to become a leader in skincare.

In 2009, a unique partnership with Pfizer led to the launch of ViiV Healthcare, a company focused on delivering advances in treatment and care for HIV communities. Using the expertise of both companies and Shionogi, who joined in 2012, ViiV Healthcare now has a portfolio of thirteen HIV treatments.

In 2014, GSK submitted a file to the European Medicines Agency for the world’s first malaria candidate vaccine, and received a positive opinion in 2015. The WHO is now embarking on a pilot implementation of the candidate vaccine involving 750,000 children in Ghana, Kenya and Malawi.

In March 2015, GSK completed a transaction with Novartis to acquire their vaccines business (excluding influenza vaccines), strengthening the company’s position as the world’s leading vaccine manufacturer.

Subsidiaries of Mylan

Among GSK’s notable subsidiaries are:

  • Beecham Group plc
  • Cellzome, Inc. 
  • Coulter Pharmaceutical, Inc. 
  • Domantis Limited
  • Glaxo Group Ltd. 
  • Stiefel Laboratories, Ltd. 
  • Wellcome Ltd. 

A full list of subsidiaries may be found here: https://www.gsk.com/media/5349/annual-report-2018.pdf

Popular Pharmaceutical Products of GSK

The top products of GSK are: 

  1. Adartrel (ropinirole hydrochloride)
  2. Advair (salmeterol, fluticasone propionate)
  3. Altabax (retapamulin ointment)
  4. Altargo (retapamulin)
  5. Amerge (naratriptan)
  6. Amoxil (amoxicillin)
  7. Anectine (suxamethonium chloride)
  8. Argatroban (argatroban)
  9. Arixtra (fondaparinux sodium)
  10. Arranon (nelarabine)
  11. Arzerra (ofatumumab)
  12. Atriance (nelarabine)
  13. Augmentin (amoxicillin/clavulanate potassium)
  14. Avamys (fluticasone furoate)
  15. Avandamet (rosiglitazone/metformin HCl)
  16. Avandaryl (rosiglitazone maleate / glimepiride)
  17. Avandia (rosiglitazone maleate)
  18. Avodart (dutasteride)
  19. Bactroban (mupirocin)
  20. Benlysta (belimumab)
  21. Betnovate (betamethasone valerate)
  22. Bexxar (tositumomab)
  23. Breo (fluticasone furoate/vilanterol)
  24. calpol (paracetomol)
  25. Ceftin (cefuroxime axetil)
  26. Combodart (dutasteride / tamsulosin hydrochloride)
  27. Coreg (carvedilol)
  28. Coreg CR (carvedilol phosphate)
  29. Cutivate (fluticasone propionate)
  30. Daraprim (pyrimethamine)
  31. Dermovate (clobetasol propionate)
  32. Duodart (dutasteride / tamsulosin hydrochloride)
  33. Dyazide (hydrochlorothiazide/triamterene)
  34. Eumovate (clobetasone butyrate)
  35. Flixonase (fluticasone propionate)
  36. Flixotide (f988luticasone propionate)
  37. Flolan (epoprostenol)
  38. Flovent (fluticasone propionate)
  39. Fortum (ceftazidime)
  40. Horizant (gabapentin enacarbil)
  41. Hycamtin (topotecan)
  42. Imigran (sumatriptan succinate)
  43. Imitrex (sumatriptan succinate)
  44. Integrilin (eftifibatide)
  45. Jalyn (dutasteride / tamsulosin hydrochloride)
  46. Lamictal (lamotrigine)
  47. Levitra (vardenafil HCl)
  48. Lovaza (omega-3-acid ethyl esters)
  49. Malarone (atovaquone and proguanil hydrochloride)
  50. Mepron (atovaquone)
  51. Mivacron (mivacurium chloride)
  52. Naramig (naratriptan hydrochloride)
  53. Nimbex (cisatracurium besilate)
  54. Otosporin ear drops (polymyxin B sulphate, neomycin sulphate, hydrocortisone)
  55. Paxil (paroxetine)
  56. Pentostam (sodium stibogluconate)
  57. Potiga (ezogabine)
  58. Prolia (denosumab)
  59. Promacta (eltrombopag)
  60. Relenza (zanamivir)
  61. Requip (ropinirole hydrochloride)
  62. Respontin nebules (ipratropium bromide)
  63. Revolade (eltrombopag)
  64. Rythmol (propafenone hydrochloride)
  65. Rythmol SR (propafenone hydrochloride)
  66. Seretide (salmeterol xinofoate, fluticasone propionate)
  67. Serevent (salmeterol xinafoate)
  68. Seroxat (paroxetine hydrochloride)
  69. Staxyn (vardenafil hydrochloride)
  70. Tracrium (atracurium besilate)
  71. Treximet (sumatriptan and naproxen sodium)
  72. Trimovate (clobetasone butyrate)
  73. Trobalt (retigabine)
  74. Tykerb (lapatinib)
  75. Tyverb (lapatinib)
  76. Ultiva (remifentanil hydrochloride)
  77. Valtrex (valaciclovir hydrochloride)
  78. Varubi (rolapitant)
  79. Ventolin (salbutamol sulphate)
  80. Ventolin HFA (albuterol)
  81. Veramyst (fluticasone furoate)
  82. Volibris (ambrisentan)
  83. Votrient (pazopanib)
  84. Wellbutrin (bupropion hydrochloride)
  85. Wellvone (atovaquone)
  86. Zantac (ranitidine hydrochloride)
  87. Zeffix (lamivudine)
  88. Zejula (niraparib)
  89. Zinacef (cefuroxime)
  90. Zinnat (cefuroxime axetil)
  91. Zofran (ondansetron hydrochloride)
  92. Zovirax (aciclovir)
  93. Zyban (bupropion hydrochloride)

GSK also produces the following vaccines:

  1. ACWY Vax (for meningococcal polysaccharides serogroups A, C, W135 and Y)
  2. Ambirix (for hepatitis A (inactivated) and hepatitis B (rDNA) (HAB))
  3. Boostrix (for tetanus toxoid, reduced diphtheria toxoid and acellular pertussis)
  4. Cervarix (for human Papillomavirus vaccine (types 16, 18))
  5. Engerix-B (for hepatitis B)
  6. Fendrix (for hepatitis B (rDNA))
  7. Fluarix (for influenza)
  8. FluLaval (for influenza)
  9. Havrix (for hepatitis A)
  10. Hepatyrix (for hepatitis A and typhoid polysaccharide)
  11. Hiberix (for haemophilus B)
  12. Infanrix (for diphtheria and tetanus toxoids and acellular pertussis)
  13. Infanrix IPV (for diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis)
  14. Kinrix (for diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus)
  15. Menhibrix (for meningococcal groups C and Y and haemophilus b tetanus toxoid conjugate)
  16. Menitorix (for Haemophilus influenzae type b and Neisseria meningitidis group C (Hib-MenC))
  17. Pandemrix (for influenza)
  18. Pediarix (for diphtheria and tetanus toxoids and acellular pertussis, hepatitis B and inactivated poliovirus)
  19. Priorix (for measles, mumps and rubella)
  20. Rotarix (for human rotavirus)
  21. Synflorix (for pneumococcal polysaccharide)
  22. Twinrix (for hepatitis A and hepatitis B)
  23. Typherix (for typhoid)
  24. Varilrix (for varicella)

GSK also produces the following consumer health products:

  1. Abreva (Docosanol)
  2. alli (Orlistat)
  3. Aquafresh (oral healthcare)
  4. Astring O Sol (oral healthcare)
  5. Beechams Cold & Flu and Night/Day Nurse (cold and flu treatments)
  6. Binaca (oral healthcare)
  7. Biotene (oral healthcare)
  8. Boost (nutritional)
  9. Breathe Right (respiratory)
  10. Cetebe (vitamins and naturals)
  11. Chlorhexamed (oral healthcare)
  12. Cholinex (analgesics and respiratory tract)
  13. Citrucel (gastrointestinal)
  14. Coldrex (cold and flu treatment)
  15. Commit Lozenge (smoking cessation)
  16. Committed Quitters (nicotine replacement)
  17. Corega (oral healthcare)
  18. Corsodyl (oral healthcare)
  19. Crocin (analgesics and respiratory tract)
  20. Dr. Best (oral healthcare)
  21. ENO (gastrointestinal)
  22. Eumovate (dermatological)
  23. Fenbid (analgesics and respiratory tract)
  24. Flonase (fluticasone propionate)
  25. Formigran (analgesic/triptan)
  26. Grand-PA (headache/toothache/pain and fever)
  27. Hinds (dermatological)
  28. Horlicks (nutritional)
  29. Horlicks Promind (nutritional)
  30. Junior Horlicks (nutritional)
  31. Iodex (pain relief)
  32. Iodosan (cold and flu treatment)
  33. Macleans (oral healthcare)
  34. Maltova (nutritional)
  35. Maxinutrition (nutritional)
  36. Medacalm (vitamins and naturals)
  37. Nicorette (nicotine replacement)
  38. NiQuitin CQ/ Nicoderm CQ/ Nicabate (nicotine replacement)
  39. Odol (oral healthcare)
  40. Odol-med3 (oral healthcare)
  41. Os-cal (oral healthcare)
  42. Panadeine (analgesics and respiratory tract)
  43. Panadol (analgesics and respiratory tract)
  44. Parodontax (oral healthcare)
  45. Piriton/Piriteze (anti-allergy)
  46. Polident (oral healthcare)
  47. Poligrip Ultra (oral healthcare)
  48. Rutinoscorbin (vitamins and naturals)
  49. Scott’s Emulsion (vitamins and naturals)
  50. Sensodyne (oral healthcare)
  51. Shumitect (oral healthcare)
  52. Solpadeine (analgesics and respiratory tract)
  53. Super Poligrip (oral healthcare)
  54. Super Wernet’s (oral healthcare)
  55. Synthol (oral healthcare)
  56. Theraflu(Respitory)
  57. Tums (gastrointestinal)
  58. Viva (vitamins and naturals) Origin: Nepal
  59. Zovirax (dermatological)

Product Recalls and Lawsuits

  1. In March 2014, GSK voluntarily recalled from warehouses and distributors a number of batches of nicotine lozenges sold globally, after the company detected manufacturing issues affecting some batches. In some cases, the lozenges were larger or smaller than GSK’s manufacturing standards. 
  2. In 2013, a baby vaccine supplied by GlaxoSmithKline Australia ($GSK) has been recalled over concerns about bacteria found in the Belgian factory where it was made. About 115,000 doses of Infanrix hexa vaccine–which protects against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b–were recalled due to potential contamination.
  3. In 2014, GSK recalled Panadol Advance bottles due to failure to meet child-resistant closure requirement. The bottles were sold exclusively in Puerto Rico.
  4. In March 2014 it recalled Alli, an over-the-counter weight-loss drug, in the United States and Puerto Rico because of possible tampering, following customer complaints.
  5. In February 2018, GSK voluntarily recalled four lots of Ventolin (Diskus/Accuhaler) and seven lots of Seretide (Diskus/Accuhaler) devices.

The issue, which occurred during the assembly of the devices, involved a foil strip containing the medicine inside the device which may have been damaged, reducing the full number of doses the inhaler may deliver.

Litigation Settlements

  1. GSK currently holds the record for the largest settlement between a pharmaceutical company and the United States. In 2012, GSK settled a USD3bn criminal and civil suit that alleged that the company participated in off-label promotion and failed to disclose safety data. The suit also alleged that GSK paid kickbacks to physicians, and made false and misleading statements concerning the safety of Avandia. Moreover the suit also alleged that GSK reported false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
  2. In 2010, GSK settled a USD 750 million suit that alleged that the company practiced poor manufacturing practices in producing the drugs Kytril/Bactroban and Paxil CR/Avandamet. 
  3. GlaxoSmithKline Plc agreed to pay $105 million to settle allegations by 44 U.S. states and the District of Columbia that it promoted its medicines for unapproved uses in 2014. Glaxo was accused by the states of illegally marketing its big-selling asthma drug Advair for use by mild asthma sufferers and the antidepressants Paxil and Wellbutrin for use by children and teenagers without FDA approval. Several antidepressants have been associated with increased risk of suicide in younger patients.

Sources:

https://www.gsk.com/media/5349/annual-report-2018.pdf

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

https://money.cnn.com/2014/03/27/news/companies/glaxosmithkline-alli-recall

https://www.fiercepharma.com/r-d/gsk-recalls-infant-vaccine-australia

https://www.cpsc.gov/Recalls/2014/gsk-recalls-panadol-advance-bottles

Did Johnson and Johnson Recall Talc? 

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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

Posted on

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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