Valsartan Drug Recall: What You Need to Know Now

Do you or a loved one take medication for high blood pressure or a heart condition that contains valsartan? Or have you taken valsartan-containing medicine in the past? You could be at risk for certain cancers due to “unexpected impurities” discovered in some of these drugs.

Now the subject of an expanding recall and FDA investigation, valsartan is a generic ingredient contained in medications produced by a long list of drug manufacturers. And, while not all valsartan is being recalled, that originating from Zhejiang Huahai Pharmaceuticals (Huahai) in China, has been found to be contaminated by probable carcinogens.

This means that long-term use of medications made with the tainted valsartan may cause cancer, particularly of the liver or colorectal systems, according to medical professionals and researchers.

The problem

To date, some valsartan has been found by the US Food and Drug Administration, as well as other international regulatory entities like the European Medicines Agency, to be contaminated with two different cancer-causing chemicals: N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).

The contamination issue was first brought to light in July 2018, when Indian drug manufacturer Torrent Pharmaceuticals Limited, informed the FDA that they had found NDMA in the valsartan they had been using as the active pharmaceutical ingredient (API) in several products. Most of this contaminated valsartan had been produced by Huahai.

Torrent began a voluntary product recall at that time, and the FDA initiated their own testing, as well as inspections of Huahai’s facilities in eastern China to determine what had caused the contamination. More recently, as a result of the investigations and laboratory testing of both tainted and safe valsartan, the additional NDEA contamination was discovered in some products also originating from Huahai.

The FDA has put the Chinese manufacturer on an import alert as of late September 2018, which means they are now banned from importing their products into the United States. However, the contamination problem may have begun as early as 2012, according to reporting from Reuters.

What you should do if you take valsartan

If you have a current prescription for valsartan or a valsartan-containing medication, there are several courses of action you can take right away:

• If you know for certain that your valsartan product is under recall, talk to your doctor immediately about whether medical testing for certain cancers is advised. The higher risk of cancer associated with the recalled valsartan products comes from long-term exposure to the NDMA and NDEA chemicals, so if you have not been taking the affected product for very long, your risk may not be higher than that of people who were not exposed.
• Talk with your doctor to discuss your options for alternative medications. It is important to remember that not all valsartan is contaminated or under recall and is still considered safe. Never simply stop taking any medication prescribed to you before first consulting your doctor.
• Visit your pharmacy and ask whether any valsartan you were dispensed in the past has been recalled. In Pennsylvania, pharmacies are legally allowed to substitute lower-cost generic medications for brand-name drugs prescribed by your doctor unless specifically directed otherwise. This means that the valsartan you received at the pharmacy counter may not have been from a manufacturer you expected (or even knew of). This policy is intended to save consumers money, but can have unintended consequences. Your pharmacy will have a record of generic substitutions made in the past, as this is also required by law.

What to do if you suspect valsartan has caused your cancer

Because the tainted valsartan may have been on the market since 2012 or 2013, according to investigative reports, long-term exposure to the cancer-causing NDMA and NDEA chemicals is possible. If you have taken valsartan in the past and then developed cancer, especially of the liver, or if you’ve sustained other serious liver problems, you may be a victim of defective valsartan.

The good news is that you may have legal options to recover compensation for your injuries, and we would love to consult with you here at Westmoreland Injury Lawyers.

Don’t wait. If you or a loved one has developed cancer or suffered other injuries that you suspect may be related to taking valsartan, you may have a case. Contact us now to discuss your options for FREE. Our experienced attorneys have been fighting back against unethical practices in the pharmaceutical industry for over 25 years, and we are here to help YOU.