Mylan Warned About Potential Cancer-Causing Contaminants in Valsartan

In 2018, the U.S. Food and Drug Administration (FDA) recalled valsartan manufactured by Zhejiang Huahai Pharmaceutical Co because it was contaminated with N-nitrosodimethylamine (NDMA). NDMA is a carcinogen and may cause liver problems.

Since then, the FDA has issued other warnings and voluntary recalls for valsartan and other angiotensin II receptor blockers (ARBs).

November 2019 Valsartan Warning

In late May and early June 2019, the FDA inspected Mylan Laboratories, Limited’s drug manufacturing plant in Andhra Pradesh, India, and found significant safety problems at the plant. After the inspection, the FDA shared its findings with Mylan, and Mylan responded to the FDA’s concerns. However, the FDA found Mylan’s response inadequate because it Woman Looking at a Warning Letter for Valsartandid not provide enough detail about the corrective action it would take to prevent future problems.

Accordingly, on November 5, 2019, the FDA warned Mylan that it had several “significant deviations” from good manufacturing practices, and the agency warned Mylan of serious consequences if it did not make changes to correct the deviations.

Specifically, the FDA found that Mylan:

  • Did not have adequate written procedures for receiving, identifying, testing, and handling raw materials. Furthermore, Mylan’s existing procedures did not prevent NDMA contamination or other dangerous contaminants.
  • Did not clean equipment to prevent contamination that would change the quality of the active pharmaceutical ingredients from the established specifications

The FDA specifically noted that these deviations may not be the only safety problems at Mylan’s Andhra Pradesh, India plant and that the burden of identifying and fixing these deviations is on the pharmaceutical manufacturer. In its letter to Mylan, the FDA recommended possible corrective actions and strongly encouraged the pharmaceutical company to hire independent, qualified, third-party reviewers to assess specific safety procedures in the plant.

What Valsartan Users Need to Know Now

Your doctor recommends that you take valsartan to treat your high blood pressure or congestive heart failure. You agree with your doctor’s recommendation, fill your prescription, and take your medication as directed. However, there is no way for you to know if your blood pressure medication was contaminated with dangerous, potentially cancer-causing substances during manufacturing. You should speak with your pharmacists about the origins of your medication and to your doctor about whether the benefits of valsartan outweigh the potential dangers.

Additionally, you should make sure that your legal rights are protected if:

  • You have taken valsartan since 2015
  • You have taken valsartan for at least one year

You may have already developed, or you may be at risk of developing liver cancer, colorectal cancer, or stomach cancer. Your whole life may change, and you could face significant expenses that include but are not limited to:

  • Medical costs for doctors’ visits, hospitalizations, cancer treatments, and rehabilitation therapies
  • Lost income for time that you cannot work due to cancer or cancer treatment
  • Out of pocket expenses that come with cancer or cancer or cancer treatment
  • Physical pain and emotional suffering that may be among the most serious side effects of cancer or cancer treatment

An experienced injury lawyer can help you get the recovery that you deserve. Other people have already filed class-action lawsuits against other pharmaceutical companies because of NDMA contamination of valsartan. One class action is against Zhejiang Huahai Pharmaceutical Co. and it alleges that the pharmaceutical company destroyed evidence and willingly and recklessly allowed contaminated valsartan to be sold. Another lawsuit requests that anyone who took contaminated valsartan be provided with free medical monitoring so that any cancer that develops can be diagnosed and treated quickly.

It may be too soon to know whether anyone was hurt by the potentially dangerous practices at Mylan Laboratories in India. However, it is not too soon to start protecting your rights.

If you’ve developed cancer after taking valsartan or you are concerned about potential cancer from your blood pressure or heart medication, then we encourage you to contact Keefe Disability Law today to learn more about your rights and protecting your possible recovery.

 

John L. Keefe
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Founding Attorney, Massachusetts Social Security Disability Lawyer
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