Contamination of the heart drug valsartan may have been putting patients at risk for cancer, according to recent announcements by government agencies.

The heart drug valsartan is a generic medication used to treat a variety of cardiovascular conditions including hypertension, heart failure, and prevention of a second cardiac arrest following a first event. It is reportedly used in patients as young as six years old. Because the heart drug valsartan is no longer under patent and is a generic, it is made by multiple pharmaceutical manufacturers globally.

One of the manufacturers based in China and known as Zhejiang Huahai Pharmaceuticals was recently discovered to have released a batch of the heart drug valsartan that is allegedly impure. The news of the impurity was announced the European Medicines Agency (EMA)—the equivalent of the U.S. Food and Drug Administration (FDA)—in May 2018.

According to the EMA, the heart drug valsartan supplied by Zhejiang Huahai Pharmaceuticals contained N-nitrosodimethylamine (NDMA). This product has been identified as likely capable of producing cancer in humans by a number of worldwide health organizations. According to a recent CNN article, NDMA is an organic chemical that can accidentally find its way into pharmaceutical manufacturing.

NDMA is a byproduct of fish processing, as well as one that occurs by manufacturing pesticides. It is also used to make fuel for rockets. Because of this, the EMA and authorities in the United Kingdom (UK) instigated a campaign to get pharmacies to pull the potentially tainted heart drug valsartan and a similar product known as valsartan HCTZ from their shelves.

The U.S. Food and Drug Administration has stepped up to the plate by convincing three packagers of the generic remedy in the U.S. to voluntarily recall the drug products. Associated pharmacies have been asked to return batches of the potentially tainted heart drug valsartan and valsartan HCTZ to these manufacturers without delay. The FDA continues to investigate the levels of NDMA in the cardiovascular medicines and hopes to come up with a plan to prevent this problem from happening again.

According to the CNN article, the FDA estimates that the maximum dose given to 8,000 people over four years would likely produce only one additional instance of cancer. All changes in medication should be under the advice and over site of the prescribing physician. Sudden changes in drug regimen could be dangerous for overall heart health, according to the American Heart Association.

Additionally, it is important to know that only certain valsartan products have been recalled. Of concern are products produced or distributed by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals. The FDA is publishing updates as new packagers are added to the list. Patients can contact their local pharmacy for information on their supply and determine if a replacement is available from a different producer or distributor not believed to be connected to the China manufacturing site associated with the tainted heart drug valsartan.

In late summer, two plaintiffs have come forward to file a class action lawsuit against two manufacturers and two pharmacies in the U.S. District Court of New York. The valsartan lawsuit has yet to be certified by the court. If you took a valsartan medication, however, you may qualify to participate in a current class action investigation. Fill out our form to request a free legal consultation.