Last Updated December 10, 2020

The uses for talc don’t stop with body powders though. Its absorbent propensity makes it ideal for other use in consumer products such as cosmetics, where it has been adopted in the processes for manufacturing a long list of popular brands with everyday applications. Additionally, talc may even be used in some food items such as rice, chewing gum, and pill tablets.

For years, cosmetic manufacturers and other product developers have understood that talc is frequently mined in close proximity with asbestos, a potent known carcinogen that when inhaled can cause lung cancer and/or mesothelioma. Additionally, it is widely suspected that asbestos-contaminated talc is linked with incidences of ovarian cancer as well as some other illnesses when applied to female genitalia.  

Since 1976, the Cosmetic, Toiletry and Fragrances Association (now known as the “Personal Care Products Council”) has promoted a voluntary standard among its members requiring that their talc products be free of “detectable amounts” of asbestos. Unfortunately, the “detectable” standard is at odds with what many researchers consider safe. They believe that there are no safe levels of asbestos exposure – detectable or not.

What Cosmetic Products Typically Contain Talc?

Cosmetic manufacturers frequently use talc in their products because of its absorbency, caking prevention and improvements in consistency.  It typically appears in setting powder, eye shadow, liquid foundation or anything which absorbs oil on the skin surface.  Some of the other more common cosmetic categories featuring talc include:

Have Cosmetic Products Been Recalled for Asbestos Concerns?

In 2019, the U.S. Food and Drug Administration (FDA) issued alerts and warnings concerning at least two popular cosmetic brands and some of their product lines. First, in March 2019, the FDA advised consumers to not use some products by Claire’s because of suspected asbestos contamination.  Specifically, the FDA referenced the following lots of products:

• Claire’s Eye Shadows – Batch No/Lot No: 08/17
• Claire’s Compact Powder – Batch No/Lot No: 07/15
• Claire’s Contour Palette – Batch No/Lot No: 04/17

In June 2019, Claire’s and another store, Beauty Plus, voluntarily recalled products due to additional testing which found suspected asbestos contamination. The recall involved:

• Beauty Plus Global Contour Effects Palette 2, Batch No. S1603002/PD-C1179
• Claire’s JoJo Siwa Makeup Set, SKU #888711136337, Batch/Lot No. S180109

These actions were followed in September 2019, with another FDA warning and voluntary recall on more product lines by Beauty Plus Global which tested positive for asbestos:

• Beauty Plus Global Inc. City Color Collection Matte Blush (Fuchsia), SKU #849136008807, Lot No. 1605020/PD-840
• Beauty Plus Global Inc. City Color Cosmetics Timeless Beauty Palette, SKU #849136012958, Lot No. 1510068/PD-C864R
• Beauty Plus Global Inc. City Color Bronzer (Sunset), SKU #849136016017, Lot No. 160634/PD-P712M
• Beauty Plus Global Inc. Beauty Plus Global Inc. City Color Shimmer Bronzer (Caramel), SKU #849136017106, Lot No. 1612112/PD-840

The FDA advised consumers not to use any of these products.

Does Talc in Makeup Cause Cancer or Have Other Side Effects?

Going back to the 1960s, it has been understood that, even at low levels, asbestos is a potent carcinogen and the cause of lung cancer and mesothelioma. Since that time, the cosmetic industry has gone to great lengths to claim that products that contain talc have “non-detectable” levels of asbestos in them. The term “non-detectable” is a careful choice of words on the industry’s part. With that in mind, a multitude of studies has failed to draw a direct linkage between ordinary “non-detectable” or “asbestos-free” talc-containing products and lung cancer.

Ovarian Cancer

Physicians, consumer advocates, industry representatives, and patients have been aware of a suspected linkage between the sprinkling of talc on female genitalia (“perineal dusting”) and higher rates of ovarian cancer for decades. They also have vehemently different opinions about its existence. Despite the disagreement between these groups as to whether genital talc exposure causes ovarian cancer, a growing body of evidence increasingly suggests a possible connection. 

As a predicate, it is important to note that statistically, the rate of ovarian cancer in the general population is around 1%, which is substantially lower than the rate for breast cancer. However, a series of research studies involving large groups of women who have used talcum powder has uncovered that these women are about 30% more likely to be diagnosed with ovarian cancer. Naturally, the world’s largest manufacturer of talc powder, Johnson & Johnson, vehemently disputes these findings and to this day insists that its products are safe.

Alternatives to Talc in Cosmetics

The bottom line for consumers who are leery of the risks posed by talc in cosmetics is that they must pay close attention to labels and the business practices of the brands they shop. Specifically, consumers should look for the following on labels: talc; talcum powder; and/or magnesium silicate.

The good news is that there are a wide variety of cosmetic brands that manufacture products that do not feature talc or talc-derived ingredients.  For instance, some baby powder brands have switched from talc to corn starch. Additionally, organizations such as the Campaign for Safe Cosmetics have taken the lead in consolidating timely information about which products contain talc and where to look for alternatives.

Is the FDA Investigating Talc in Cosmetics?

In February 2020, the FDA opened a public docket to discuss and collect scientific data on talc ingredients in cosmetics. The FDA and members of an interagency working group continue to work together to evaluate the science surrounding talc, asbestos contamination, and cosmetics. The immediate goal of the group is to potentially develop recommendations for testing of asbestos in talc.

Last Updated December 18, 2020

Zantac is the brand name for ranitidine, a very popular medication used for the treatment of issues associated with heartburn, ulcers, and Gastro-Esophageal Reflux Disease (GERD). Ranitidine is part of a larger family of drugs known as histamine H2-receptor antagonists or “H2-blockers” for their method of action in blocking the action of histamine cells in the stomach lining.

Approved in 1983 for prescription use by the U.S. Food and Drug Administration (FDA), Zantac was wildly successful and by 1986 netted over $1 billion in sales for pharmaceutical giant, GlaxoSmithKline – making it one of biggest runaway hits in history. Zantac eventually went over-the-counter (OTC) in 1996 and following its move “off-patent” became an equally successful generic drug. In 2018, Zantac (ranitidine) ranked as one of the top-10 antacid tablets in the United States.

In 2019, things began to unravel for Zantac and the story of its meteoric rise to pharmaceutical sensation. A small, upstart testing laboratory in Connecticut revealed the presence of N-Nitrosodimethylamine, a potent carcinogen also known as “NDMA” in batches it sampled. It is now believed that the NDMA in Zantac may be the result of natural breakdown processes in ranitidine itself which potentially expands the range of exposure to nearly every person who has ever taken Zantac. In April 2020, the FDA announced a total recall of all Zantac (ranitidine) products from the market.

How does Zantac Function?

Histamine is a naturally occurring chemical present throughout the body which interacts with the cells in the stomach lining to promote the production of stomach acid. Drugs like Zantac work to block the histamine receptors traveling through the stomach, thereby limiting the signal to produce stomach acid.

How Long Does It Take Zantac to Work?

Zantac is absorbed into the bloodstream, unlike more traditional calcium carbonate antacids. However, in contrast to proton pump inhibitors (PPIs) which can take several days or weeks to activate, it will begin to work and provide relief of acid indigestion and heartburn within 1-2 hours.

How Many Brands of Zantac (ranitidine) Were on the Market at the Time of Recall?

The following is a list of branded Zantac and generic ranitidine brands at the time of recall:

What Are the Common Side Effects of Zantac?

Common Zantac side effects include, but are not limited to:

What is the Risk of Cancer from NDMA?

The International Agency for Research on Cancer (IARC) classifies NDMA as a Group 2A carcinogen which means they believe it is “probably carcinogenic to humans”. Specifically, it is believed that NDMA causes mutations in human DNA which can lead to harmful cancers. In humans intentionally poisoned with NDMA, severe liver damage and internal bleeding have resulted. Animal studies have revealed NDMA to be toxic even after short-term exposure.

What Cancers Are Associated with NDMA?

Research into NDMA and human exposure have yet to draw a definitive link between NDMA, Zantac, and cancer. The causes of cancers in humans are numerous and can range from factors involving behaviors such as smoking and drinking to a genetic predisposition to environmental factors and obesity. Accordingly, it is difficult to put a precise finger on what cancers could develop from NDMA contamination in Zantac. Nonetheless, researchers have theorized that long-term exposure through Zantac could be associated with the following types of cancer:

• Stomach
• Bladder
• Colorectal
• Liver
• Esophageal
• Small Intestinal

Although less prevalent in research, NDMA has also been linked to these types of cancers:

Does Zantac Interact with Other Medications?

Research has documented observations of Zantac interacting with common blood-thinners such as Warfarin. This interaction resulted in fluctuating levels of a blood test measuring prothrombin timing. Additionally, studies of Zantac suggest the possibility that it could interact with acetaminophen, ibuprofen, and metformin.

Is It True that Zantac Manufacturers Are Involved in Lawsuits?

Yes. In 2019, several individuals suffering from cancer who believe that their illness stems from taking Zantac contaminated with NDMA filed lawsuits against manufacturers such as: 

• Boehringer Ingelheim Pharmaceuticals, Inc.
• Sanofi Aventis, S.A./Sanofi-U.S. Services, Inc.
• Chattem, Inc.
• Pfizer, Inc.
• GlaxoSmithKline, Inc.

Cases have now been consolidated into single multidistrict litigation (MDL-2924) taking place in West Palm Beach, Florida. New cases are being added at this time.

Updated November 21, 2020

Zantac is the brand name of ranitidine, one of the most popular medications ever used to treat and prevent conditions such as heartburn; ulcers, and Gastro-Esophageal Reflux Disease (GERD). It is part of a family of drugs known as H2-blockers for their method of action blocking histamine cells in the stomach.

Zantac was one of the best-selling drugs in history and made enormous profits for both GlaxoSmithKline and Sanofi as well as serving as a center of enormous prestige for both companies. However, those profits and prestige took a big hit in 2019 when a small testing lab in Connecticut discovered trace amounts of N-nitrosodimethylamine (NDMA) in batches of ranitidine. NDMA has been recognized by the U.S. Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) as a probable human carcinogen.

Upon the release of these results, some generic manufacturers of ranitidine began voluntary recalls of their products in 2019. This was followed by the announcement of a mandatory withdrawal of ranitidine from the market by the U.S. Food and Drug Administration (FDA) on April 1, 2020.

What is NDMA?

According to the EPA, NDMA is a semivolatile organic chemical. Although it is not typically produced intentionally in the United States, it can be produced unintentionally through chemical reactions in products or industrial processes. It is believed that when NDMA is consumed, it modifies cellular DNA, increasing cancer risk substantially.  Studies of NDMA and cancer risk have largely taken place only in animals as direct research from humans is still very limited.

How Did NDMA Wind Up in Zantac?

Valisure, a small laboratory in Connecticut, was the first testing facility to discover and report on NDMA contamination in Zantac/ranitidine. The lab believes that the NDMA in ranitidine is the result of the molecular instability of the drug itself and may form as a natural byproduct of its breakdown over time.

What Cancers are Associated with NDMA?

Cancer risk can stem from a number of factors unique to each person and their circumstances. Cancer can be linked to things such as infectious agents; genetic predisposition; behavioral factors and habits like diet, smoking, alcohol use, obesity, and diet; or even exposure to pollution. Also, it is important to remember that researchers have not yet established a conclusive link between Zantac NDMA contamination and cancer. However, it is theorized that long-term exposure to NDMA could be linked with the following cancers:

• Stomach
• Bladder
• Colorectal
• Liver
• Esophageal
• Small Intestinal

Although less prevalent in research, NDMA has also been linked to these types of cancers:

• Breast
• Thyroid
• Testicular
• Leukemia
• Non-Hodgkin’s Lymphoma
• Multiple Myeloma

• Prostate
• Ovarian
• Pancreatic
• Lung
• Uterine
• Brain

Ranitidine Manufacturers and FDA Recall

Upon announcement of the Valisure laboratory results, several generic manufacturers of ranitidine, led by Sandoz, both halted the distribution of their ranitidine products and later recalled their brands from store shelves. However, Sanofi, the manufacturer of branded Zantac ranitidine tablets initially declined to halt sales of Zantac. The company instead publicly stated that “The FDA reported levels of [NDMA] in ranitidine in preliminary tests barely exceed amounts found in common foods”.

On April 1, 2020, the FDA announced a complete market withdrawal and removal from shelves of all prescription and over-the-counter (OTC) forms of Zantac and generic equivalents of ranitidine. The agency said its decision was prompted by Valisure’s testing as well as its own testing which revealed the presence of NDMA under normal storage conditions, and even higher amounts when ranitidine is stored at higher temperatures. Furthermore, the FDA’s testing revealed that the older a ranitidine product is (the length of time following manufacture) the greater the amount of NDMA is present.

Branded Zantac and Generic Ranitidine Brands Recalled/Withdrawn

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2) “Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA)” https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf

3) “The Zantac problem: What’s NDMA?” https://abcnews.go.com/Health/zantac-problem-whats-ndma/story?id=65799147

4) “FDA Requests Removal of All Ranitidine Products (Zantac) from the Market” https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market

5) “FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)” https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine

6) “Recalls, Market Withdrawals, & Safety Alerts” https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

7) “NDMA, a contaminant found in multiple drugs, has industry seeking sources and solutions” https://cen.acs.org/pharmaceuticals/pharmaceutical-chemicals/NDMA-contaminant-found-multiple-drugs/98/i15

8) “Ranitidine Cancer Risk“ https://www.medpagetoday.com/meetingcoverage/ddw/86314

9) “Health Risks Associated with N-Nitrosodimethylamine (NDMA)” https://www.labmanager.com/insights/health-risks-associated-with-n-nitrosodimethylamine-ndma-656

10) “What We Know about the Possible Carcinogen Found in Zantac” https://www.scientificamerican.com/article/what-we-know-about-the-possible-carcinogen-found-in-zantac/#:~:text=In%20its%20petition%2C%20Valisure%20also,break%20down%20to%20form%20NDMA.

11) “The Finding of N‐Nitrosodimethylamine in Common Medicines” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288647/

12) “Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine” https://pubmed.ncbi.nlm.nih.gov/26992900/

13) “Formation Mechanism of NDMA from Ranitidine, Trimethylamine, and Other Tertiary Amines during Chloramination: A Computational Study” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4123930/

14) “Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration” https://clinicaltrials.gov/ct2/show/NCT04397445

15) “FDA asks manufacturers to remove ranitidine from market: What now?” https://www.aappublications.org/news/2020/07/01/focus-ranitidine070120

16) “Concerned about the ranitidine (brand name: Zantac) recall? Here’s what the FDA says” https://www.miamiherald.com/news/health-care/article236067123.html

17) “Some ranitidine (Zantac) has tested safe, but more recalled for too much carcinogen” https://www.miamiherald.com/news/health-care/article237219936.html

18) “A tiny pharmacy is identifying big problems with common drugs, including Zantac” https://www.washingtonpost.com/science/a-tiny-pharmacy-is-identifying-big-problems-with-common-drugs-including-zantac/2019/11/08/6dd009ca-eb76-11e9-9c6d-436a0df4f31d_story.html

19) “N-Nitrosodimethylamine (NDMA) as a Drinking Water Contaminant: A Review” https://superfund.berkeley.edu/pdf/231.pdf

20) “Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)” https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac#:~:text=FDA%20has%20found%20N%2Dnitrosodimethylamine,ranitidine%20they%20may%20currently%20have.

21) “Our Mission” https://www.valisure.com/about-us/

22) “Formation Mechanism of NDMA from Ranitidine, Trimethylamine, and Other Tertiary Amines during Chloramination: A Computational Study” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4123930/

23) “The Finding of N‐Nitrosodimethylamine in Common Medicines” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288647/

24) “Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine” https://pubmed.ncbi.nlm.nih.gov/26992900/

25) “Zantac, Ranitidine Pulled From Market, Here Are FDA’s Latest Cancer Concerns” https://www.forbes.com/sites/brucelee/2020/04/02/zantac-ranitidine-pulled-from-market-here-are-fdas-latest-cancer-concerns/#e60d6fb2b8c5

26) “Zantac is prescribed 15 million times a year. So how did it become a potential cancer risk?” https://www.usatoday.com/story/news/health/2019/11/07/how-did-zantac-become-potential-cancer-risk-fda-wants-find-out/2509043001/

27) “Ranitidine (Zantac) recall expanded, many questions remain” https://www.health.harvard.edu/blog/ranitidine-zantac-recall-expanded-many-questions-remain-2020040218044

28) “Lab finds NDMA in Zantac can develop during storage” https://www.fiercepharma.com/manufacturing/lab-finds-ndma-zantac-can-develop-during-storage-bloomberg

29) “FDA Recalls All Ranitidine (Zantac) Products, Citing Increased Risk of Cancer” https://www.ajmc.com/view/fda-recalls-all-ranitidine-products-zantac-citing-increased-risk-of-cancer

30) “Valisure Detects NDMA in Ranitidine” https://www.valisure.com/blog/valisure-news/detection-of-ndma-in-raniditine/

31) “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process – Hearing before the United States Senate Committee on Finance (June 2, 2020)” https://www.finance.senate.gov/imo/media/doc/02JUN2020.VALISURE.LIGHT.STMNT.pdf

Last Updated November 20, 2020

Valsartan has experienced widespread adoption and been a popular drug since its introduction in the 1990s. It is typically prescribed alone or in conjunction with other medications to combat high blood pressure. It is also considered a “second choice” treatment for patients who have not enjoyed success with other drugs such as ACE inhibitors such as ramipril or lisinopril.

The FDA has recalled some batches of generic Valsartan due to fears over contamination with N-Nitrosodimethylamine (NDMA), a potent carcinogen. It is believed that the contamination resulted from poor quality control practices at factories in India and China. The complete list of recalled batches and manufacturers can be found here.

Valsartan Pregnancy Warning

The FDA classifies Valsartan as a “Category D” medication, meaning there is “positive evidence” of human fetal risk based on adverse reaction data from investigations. Accordingly, Valsartan’s label comes with a prominent black box warning concerning pregnancy and fetal toxicity. The use of drugs like Valsartan can reduce fetal renal function and increase the chances of fetal death. Women who learn they are pregnant should discontinue the use of Valsartan as soon as possible.

Common Side Effects of Valsartan

Studies of Valsartan have revealed the following side effects which tend to occur in 1 or more out of 100 people taking the medication:

• Dizziness/Spinning (vertigo)
• Headaches
• Nausea
• Vomiting and diarrhea
• Joint/Muscle Pain

Liver Damage

Through its post-marketing analysis, the FDA has received reporting from drug manufacturers and physicians potentially linking Valsartan with acute liver injuries, impairment of liver function, and elevated enzymes. Symptoms will typically start to manifest one to eight weeks after starting the use of Valsartan. Patients who experience the following symptoms should contact their physician for further review:

• Jaundice
• Itchy Skin
• Chronic Fatigue
• Dark Urine
• Irregular Stool Color
• Abdominal Pain/Swelling
• Easily Bruising

Valsartan FDA Recall and Cancer Risk

In 2018, the FDA began a series of voluntary recalls following random tests of generic Valsartan which revealed NDMA contamination. NDMA is considered to be an extremely potent carcinogen.

The cancer risk associated with NDMA in Valsartan must be understood in combination with other risk factors such as genetic predisposition; environment; smoking; drinking and eating habits; and obesity. However, researchers theorize that long-term exposure to NDMA could be linked with the following cancers:

The FDA offered some perspective on the risk associated with contaminated Valsartan. In its updated announcement, the agency estimated that if 8,000 patients took 320mg of valsartan (the highest dose) contaminated with NDMA, there may be one additional cancer case during the lifetimes of those patients. The estimate is based upon average impurity levels in a single tablet of valsartan.

Last Updated November 2, 2020

Valsartan is a popular anti-hypertensive drug that has been in widespread use since the 1990s. It can be used alone or in conjunction with other medications to combat high blood pressure/hypertension or to aid in recuperation following a heart attack episode. In recent years, as generic manufacturers moved into the market for Valsartan, they took the production of this drug into factories located in India and the People’s Republic of China. The decision to move the manufacturing of generic varieties of Valsartan offshore was a fateful one as it was later discovered that some batches made in these factories were contaminated with potent carcinogens which later found their way into the U.S. drug supply.

Beginning in 2018, the U.S. Food and Drug Administration (FDA) began wide-ranging recalls of generic Valsartan.  Now, individuals suffering from various forms of cancer are suing these generic manufacturers and their lawsuits have been consolidated into a large multidistrict litigation (MDL-2875) taking place in federal court in New Jersey.

Contamination of Generic Valsartan Supplies

Valsartan is manufactured in generic formats by firms around the world. Most of the “Active Pharmaceutical Ingredient” (API) for generic Valsartan is itself subcontracted out to a handful of factories in the People’s Republic of China and India. FDA testing of certain generic brands of Valsartan revealed that some batches were contaminated with N-Nitrosodimethylamine (NDMA), an extremely potent carcinogen.  In 2018, the FDA announced recalls of contaminated batches of Valsartan as well as other similar medications such as Losartan and Irbesartan. The complete list of recalled batches and manufacturers can be found here.

It is believed that improper manufacturing processes at plants in Zhejiang, China, and Telangana, India, are to blame for NDMA contamination. These factories were outsourced by generic drug manufacturers to maximize the profitability of their brands and operated with little or no oversight or monitoring for safety and quality. Consequently, contaminated medications made their way through the supply chain and into batches circulated through the United States, Canada, and Europe.

Here is a list of some of the larger generic Valsartan manufacturers:

What Are the Risks from NDMA Contamination?

NDMA is a Group 2A carcinogen meaning that it is likely to cause cancer in humans because research has shown it to cause cancer in animals. Animals exposed to NDMA for periods over several weeks tended to show some development of liver and lung cancers as well as other types of cancer.  

A prospective study published in a 2011 issue of the American Journal of Clinical Nutrition found that NDMA is associated with a higher incidence of gastrointestinal cancer as well as rectal cancer in humans. Other studies have linked NDMA to higher incidences of esophageal, oral cavity, and pharynx cancers.

Valsartan Lawsuits

The first lawsuits naming manufacturers for their role in placing contaminated Valsartan into the drug supply began cropping up in state courts in 2018. Many of these lawsuits were removed to federal courts and in 2019 consolidated into single multidistrict litigation (MDL-2875). As of August 2020, there were 339 plaintiffs involved in this MDL.

The majority of the complaints filed by injured parties in the MDL assert that they were prescribed certain generic forms of Valsartan which were contaminated with NDMA and that in turn, they believe that the contamination is behind their cancer diagnosis. In particular, some claimants allege that contaminated Valsartan is behind a range of gastrointestinal and gastroesophageal cancers as well as liver and pancreatic cancers. Finally, claimants allege that the manufacturers were, at a minimum, negligent in their manufacturing processes and safety/quality control standards.

It is important to note that not all batches of generic Valsartan were contaminated. Lawsuits are focused entirely on generic batches that were subject to FDA recall. The domestic brands of Valsartan, such as those marketed by Novartis, under the brand name Diovan, are not part of the FDA recall.

Additionally, some potential claims alleging illness from contaminated generic Valsartan may be thwarted by the applicable statute of limitations in each state. Accordingly, if you believe you have taken contaminated generic Valsartan and have suffered an injury, you should consult with an attorney as soon as possible. An attorney can advise you about the statute of limitations and other matters that could affect your ability to file.

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2) “Leanne Gentry et al. v. Solco Healthcare U.S., LLC et al.” https://ecf.mowd.uscourts.gov/doc1/10916957329

3) Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6134800/#:~:text=Valsartan%20is%20an%20angiotensin%20II,treat%20hypertension%20and%20heart%20failure.&text=In%20July%202018%2C%20some%20valsartan,N%2Dnitrosodimethylamine%20(NDMA).

4) FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)” https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan

5) “Plaintiffs: Valsartan Manufacturers Should Have Known About NDMA Contamination” https://newyork.legalexaminer.com/health/plaintiffs-valsartan-manufacturers-should-have-known-about-ndma-contamination/

6) “Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan” https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and

7) “FDA Expands Valsartan Products Recall” https://www.pharmacytimes.com/resource-centers/cardiovascular-health/fda-expands-valsartan-products-recall

8) “Valsartan, Losartan & Other BP Med Recalls 2018-19” https://www.webmd.com/hypertension-high-blood-pressure/valsartan-losatran-bp-med-recalls-2018-19

9) “NDMA, a contaminant found in multiple drugs, has industry seeking sources and solutions” https://cen.acs.org/pharmaceuticals/pharmaceutical-chemicals/NDMA-contaminant-found-multiple-drugs/98/i15

10) “What We Know about the Possible Carcinogen Found in Zantac” https://www.scientificamerican.com/article/what-we-know-about-the-possible-carcinogen-found-in-zantac/

11) “Does NDMA Cause Cancer?” https://www.verywellhealth.com/ndma-cancer-risk-5083965

12) “N-Nitrosodimethylamine” https://pubchem.ncbi.nlm.nih.gov/compound/N-Nitrosodimethylamine

13) “Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6134800/

14) “A survey of feeding N-nitrosodimethylamine (NDMA) to domestic animals over an 18 year period” https://pubmed.ncbi.nlm.nih.gov/7228298/

15) “Dietary intakes of nitrate, nitrite and NDMA in the Finnish Mobile Clinic Health Examination Survey” https://pubmed.ncbi.nlm.nih.gov/8799716/

16) “Inflammatory bowel disease stimulates formation of carcinogenic N-nitroso compounds” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1774505/

Last Updated November 3, 2020

Generally, hearing loss is considered preventable. If properly fit hearing protective devices are consistently and routinely worn under situations involving loud noise exposure, tinnitus and noise-induced hearing loss can be avoided. Otherwise, damage done to the hearing of veterans can be debilitating. Tinnitus can make it difficult to sleep, concentrate, or relax; and progressive hearing loss is linked to anxiety, depression, heart disease, and impaired cognitive function.

Hearing Loss Symptoms and Causes in Military Veterans

According to the Hearing Loss Association of America, there are three types of hearing loss:

Conductive Hearing Loss

Conducting hearing loss is usually characterized by a malformation in either the outer ear, ear canal, or middle ear structure. It can also be caused by other factors such as a severe ear infection, benign tumors, hereditary disorders, or even impacted ear wax. This type of hearing loss is generally treated with either surgery, antibiotic medications, or with the assistance of hearing devices, such as cochlear implants or hearing aids.

Sensorineural Hearing Loss

Sensorineural hearing loss is typically caused by factors such as exposure to loud noise, head trauma, viral infections/autoimmune responses, Meniere’s disease, otosclerosis, or just plain aging. Irreversible sensorineural hearing loss, the most common form, is usually treated with hearing aids or surgically implanted devices such as cochlear implants.

Mixed Hearing Loss

A combination of conductive damage in the outer or middle ear combined with sensorineural damage in the inner ear and/or the auditory nerve.

In addition to hearing loss, many veterans suffer and cope with Tinnitus. In fact, it is the number one disability among veterans and affects nearly 10% of American adults. Described as ringing/buzzing sounds, or high-pitched whistles – the origins or tinnitus can actually be attributed to a number of causes. It could result from close proximity to an Improvised Explosive Device (IED) blast, repeated exposure to long rifle fire engagements, long term exposure to loud equipment, or something as mundane as a switch in medication. However, it is known that tinnitus and hearing loss often go hand-in-hand and tinnitus is often the first symptom of hearing damage.

Veterans and those on active duty generally have a higher risk of permanent hearing loss. Common causes of hearing loss among veterans include:

Firearms and Explosive Weapons Noise

Constant exposure to the operation of some military weapons, especially those that create noise over 140 decibels will put anyone at greater risk for loss of hearing. Additionally, they can cause “high-frequency” hearing loss making it difficult to hear anything that is 2000 hertz or higher (high-pitched voices; noisy conversions in crowded rooms; use of consonants in speech).

Ship Engines and Carrier Deck Noise

Navy veterans, especially those involved with naval aviation, are at high risk due to the loud noise involved with engine room and carrier deck operations. Engine noise can frequently exceed 112 decibels and result in hearing loss later in life. On the other hand, jet engines routinely produce sounds in excess of 160 decibels creating greater risks for pilots and deck crews of high-frequency hearing loss and tinnitus.

Jet Fuel Exposure

Kerosene-based military-grade jet fuel (also sometimes referred to as JP-8) is made up of a combination of petrochemicals that when combusted, can produce fumes interfering with neurological pathways in the brain that decipher speech and language.  Combined with other loud noise factors, jet fuel can increase a veteran or servicemember’s risk for later developing tinnitus or hearing loss.

How to Prevent Service-Related Hearing Loss

Without a doubt, hearing protection devices are key to protecting the hearing of servicemembers against damaging noise levels which can result in hearing loss or tinnitus.  

Typical hearing protection devices include:

• Triple/Quad Flange Earplugs
• Tactical Earplugs
• Tactical Communication and Protective Systems (TCAPS)
• Noise Muffs
• Foam Earplugs

According to the Hearing Center of Excellence, hearing protection devices do not ordinarily cause decreased situational awareness. Service members need to choose proper hearing protection based upon the environment, situation, noise type, and level of noise to which they are exposed.

3M Combat Arms Earplugs – Defective Protection Devices

Between 2003 and 2015, it is believed that the U.S. military purchased at least one pair of “Combat Arms” earplugs for every serviceman and servicewoman sent abroad for foreign deployment. Manufactured by a subsidiary of one of the world’s largest corporations, the 3M Company of Minnetonka, Minnesota, these earplugs were furnished to this nation’s fighting men and women for the ostensible purpose of protecting their hearing from the loud and often concussive sounds experienced during combat and training. However, veterans who were equipped with these devices now report that they experience a multitude of hearing issues which they believe stem from the defective design of the 3M Combat Arms earplugs.  

In July 2018, 3M agreed to settle a whistleblower claim brought under the False Claims Act by a competitor in U.S. ex rel. Moldex-Metric, Inc. vs. 3M Co. The allegations in that suit focused on the false statements 3M and Aearon made to the U.S. Government concerning the defective nature of the earplugs. However, as part of the settlement, 3M made no admission as to its liability or wrongdoing.

The Veterans Administration and Hearing Loss

The Veterans Administration does provide benefits and compensation for service-related disabilities involving hearing loss and tinnitus. Typically veterans must establish that their hearing issues were caused by military duty and establish:

• A current diagnosis of a hearing condition
• Evidence of an event in service that caused the condition
• A medical opinion linking the hearing issue to the service-related event

The hearing condition diagnosis, in order to be deemed service-related, must be conducted by a licensed audiologist and involve two tests:

• Maryland CNC Test
• Puretone Audiometric Test

The Veterans Administration will use these auditory test results and its regulatory formula to determine an actual rating to assign. Typically, ratings for hearing loss are 0% or 10%. Severe or profound hearing loss can qualify for a higher rating.

Noise-Induced Hearing Loss Treatment

Noise-induced hearing trauma is usually permanent in nature and at the moment, cannot be remedied with surgery or procedures removing fluid or wax blockages. Standard options to treat or ameliorate noise-induced hearing damage to involve:

Hearing Aids

Damage to the inner ear and resulting hearing loss can be remedied with a hearing aid. An audiologist can review the service member’s case file and discuss options for a device type that will present the best fit.

Cochlear Implants

More severe types of hearing loss may be more suited to a cochlear implant. This device amplifies sound and directs it into the ear canal, bypassing damaged areas in the ear structure. Service members interested in this type of solution should consult their audiologist as well as an Ear-Nose and Throat (ENT) specialist.

Last Updated November 13, 2020

Valsartan is the generic name for anti-hypertension medication frequently marketed under the names Diovan and Prexxartan in the United States. It is part of a class of drugs known as Angiotensin II Receptor Blockers (ARBs) used to primarily treat high blood pressure, heart failure, and diabetic nephropathy (kidney disease). ARBs are widely accepted within the medical community as a valuable tool to help combat the range of complications associated with type-2 diabetes. However, since moving “off-patent” and into the market for generic availability, Valsartan found itself the focus of unwanted scrutiny and lawsuits after certain batches were contaminated with N-Nitrosodimethylamine (NDMA), an extremely potent carcinogen.

Many of the claims involving Valsartan have been consolidated into multidistrict litigation (MDL) now before a federal court in New Jersey (MDL-2875). In these lawsuits, claimants allege that the manufacturers of contaminated Valsartan knew or should have known about the NDMA issue going back to at least 2012, and that they failed to warn patients and physicians about the risk.

Valsartan and Cancer Risk

As a preliminary matter, it’s important to know that not every batch of Valsartan was contaminated with NDMA. Only certain batches of Valsartan and other ARBs were subject to testing and recall. A complete list of the recalled ARBs can be found here.

NDMA is an organic chemical that is listed by the International Agency for Research on Cancer (IARC) as a group 2A carcinogen – meaning it is likely to cause cancer in humans because research has shown it to cause cancer in animals. In animal studies, NDMA has been shown to be acutely toxic to rats and even short bursts of exposure can lead to multiple organ damage in other animals. NDMA can occur both in nature or as the result of industrial manufacturing processes.

Once Valsartan became available for manufacture by generic pharmaceutical firms, most of the fabrication of its “Active Pharmaceutical Ingredient” (API) was outsourced to factories in India and the People’s Republic of China. It is believed that two facilities in particular – in Zhejiang, China, and Telangana, India, produced the API for Valsartan and are also to blame for the batches contaminated with NDMA. These batches of medication later were processed through the supply-chains throughout the United States, Canada, and Europe.

Later testing by the European Medicines Agency (EMA) and the FDA discovered the presence of N-Nitrosodiethylamine (NDEA) in other batches of ARBs from the same factories in China and India. NDEA is another similarly potent carcinogen and it is believed the poor production environment in these factories created the opportunity for both NDMA and NDEA to form as a byproduct of manufacturing.

FDA Recall

The U.S. Food and Drug Administration (FDA) began a series of voluntary recalls in 2018 following testing of batches of generic Valsartan. Since then, the FDA has continued its investigation into contaminated Valsartan as well as other ARBs such as Losartan and Irbesartan. The FDA estimates that based on its own testing NDMA and NDEA may have been present in contaminated ARB batches for up to four years.  

The FDA offered some perspective on the risk associated with contaminated ARBs. In its updated announcement, the agency estimated that if 8,000 patients took 320mg of valsartan (the highest dose) contaminated with NDMA, there may be one additional cancer case during the lifetimes of those patients. The estimate is based upon average impurity levels in a single tablet of valsartan.

Last Updated December 9, 2020

Proton Pump Inhibitors (PPIs) are prescription and over-the-counter (OTC) drugs that are designed to limit the production of digestive acid in the stomach. In patients who suffer from maladies such as Gastro-Esophageal Reflux Disease (GERD), ulcers, or other digestive conditions, PPIs are a potent tool in the arsenal to combat painful symptoms. Today, there are several brands of PPIs on the market that have generated several billions of dollars for global pharmaceutical manufacturers.

Now, decades after first being introduced onto the market, questions have emerged concerning the potential for illness and disease associated with long-term PPI use. Medical journals and research professionals have raised the possibility of PPIs being linked to kidney injuries and increased risk of permanent renal failure. In 2014, the U.S. Food and Drug Administration (FDA) imposed a requirement that all PPIs carry warnings on their labels concerning a kidney-disease precursor condition known as Acute Interstitial Nephritis (AIN).

How Do PPIs Function?

PPIs are ingested and dissolve straight into the bloodstream. When they reach a certain type of acid-producing cellular tissue in the lining of the stomach, they disrupt the production of acid-pumping enzymes.

How Long Does It Take PPIs to Work?

PPIs are meant to be taken as part of a planned regimen that accrues over several weeks. They are not meant to be taken “on-demand” or to provide immediate relief like other medications such as antacids or histamine blockers.

How Many Brands of PPIs Are On The Market?

There are several brands of OTC and prescription PPI brands on the market in the United States:

What Are the Approved Uses for PPIs?

The FDA has approved PPIs for use in adults to treat: GERD; gastric ulcer risk; Helicobacter pylori; duodenal ulcers and Zollinger-Ellison syndrome. Dosages and duration for use of PPIs will depend upon the particular brand of PPI as not all brands are exactly similar or approved for all types of illness.

What Are the More Common Side Effects Associated with PPIs?

Documented side effects from PPIs use include:

• Headache
• Nausea
• Stomach Pain
• Gas
• Constipation
• Diarrhea
• Rash
• Vomiting
• Constipation
• Fever
• Cold or Flu-like Symptoms

Are There More Serious Side Effects Associated with PPIs?

There are some more serious conditions associated with PPIs where the FDA has either taken the additional step of issuing safety communications or warnings. These include:

• Acute Interstitial Nephritis (AIN)
• Hypomagnesemia
• Clostridium Difficile Associated Diarrhea (CDAD)
• Small Intestine Bacterial Overgrowth (SIBO)
• Hip/Wrist/Spinal Fracture Risk

What is Acute Interstitial Nephritis?

AIN is a kidney disorder in which the spaces between kidney tubules become inflamed and swollen. If left unchecked, AIN can deteriorate kidney function to the point where sufferers develop Chronic Kidney Disease (CKD). Long term suffering from CKD can eventually lead to End-Stage Renal Disease (ESRD) – also known as complete renal failure. ESRD requires either a kidney transplant or dialysis for continued survival.

Do PPIs Interact with Any Other Medications?

Omeprazole, the most commonly prescribed and purchased PPI is believed to interact with at least 194 other drugs on the market. If these interactions, at least 16 are believed to be serious, 132 are thought to be moderate and 46 are minor. One of the more serious drug interactions with omeprazole (and esomeprazole) involves the blood-thinner clopidogrel (also sold under the brand names: Ceruvin, Clopilet, and Plavix). Omeprazole and esomeprazole both stall the production of the enzyme CYP2C19 which is critical to the body’s ability to metabolize clopidogrel. The FDA issued a warning in 2009 asking patients taking clopidogrel to avoid taking omeprazole and esomeprazole.

Is It True That Some PPI Manufacturers Are Involved in Lawsuits?

Yes. Lawsuits alleging kidney disease and renal injuries from PPI use were initially filed in 2016. One of the first victims to file suit was Charles Bowers, a Tennessee man who took Nexium from 2003-2008 until he was diagnosed with acute kidney disease. Mr. Bowers currently undergoes kidney dialysis 3 days a week while he awaits a kidney transplant. From there, individuals filing lawsuits naming PPI manufacturers like AstraZeneca (among others) have mushroomed considerably. Cases from across the country have now been merged into single multidistrict litigation taking place in federal court in New Jersey (MDL-2789).