Lawsuits Flow in Over Tainted Blood Pressure Drugs

Valsartan Bottle sitting on shelf

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After several recalls were issued regarding potential carcinogens tainting popular blood pressure medications, it didn’t take long before the first lawsuits were filed. And there could be thousands to come.

According to Bloomberg, dozens of lawsuits have already been filed, which could signal a wave of potential litigation. One attorney cited by Bloomberg said he anticipates more than 2,000 lawsuits associated from claims that the alleged carcinogens within the medications are linked to the development of cancer from patients who took the blood pressure medications. In addition to the potential development of cancer, some attorneys are also taking a look at potential damage to the liver from the medications to include in lawsuits. Shortly after it announced the start of the recall in July, the U.S. Food and Drug Administration (FDA) estimated that for every 8,000 people who took the highest dose of valsartan, there would be one additional case of cancer. Attorneys suggested that the claims against the drug companies over the carcinogens are valued at more than $91 million, Bloomberg said.

Over the course of the past 12 months, the FDA has issued a number of recalls associated with carcinogens found in angiotensin II receptor blocker (ARB) medications. In March, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals. The FDA said the medication used to treat high blood pressure and heart failure contained an impurity called N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), a known carcinogen. NDMA is a known environmental contaminant. For context, it is found in water and foods including meats, dairy products and vegetables.

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Last year, there were multiple recalls issued for blood pressure medications that contained other carcinogenic impurities. In November, Teva Pharmaceutical issued a voluntary recall for combination forms of its blood pressure drug Amlodipine due to cancer-causing impurities discovered in the tablets. Teva said the combinations of Amlodipine, which includes Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets contained N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. Teva’s pills were manufactured in India by Mylan.

Teva’s announcement came hard on the heels after the FDA issued a voluntary recall for lots of Irbesartan tablets developed by N.Y.-based ScieGen Pharmaceuticals due to the presence of NDEA. The ScieGen tablets were also manufactured in India, but by Aurobindo Pharma Limited. Before that, in July, the FDA issued a voluntary recall of drugs that contained the active ingredient valsartan, In the July recall, an impurity known as N-nitrosodimethylamine (NDMA), another carcinogen, was found in the products manufactured by Zhejiang Huahai Pharmaceutical Co.

The companies associated with the manufacturing and distribution of the tainted medications are and will be, the subject of the lawsuits.

The FDA initiated an investigation into the growing number of carcinogen-tainted blood pressure medications. Before his departure from the regulatory agency, former Commissioner Scott Gottlieb said the impurities may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients. Gottlieb said the FDA has developed sophisticated testing methods to track impurities in ARB medications, which work by blocking a substance in the body known as angiotensin that causes blood vessels to tighten.

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