FDA Recalls: Risk of Valsartan Contamination Should Not Be Ignored

Starting in July of this year, the U.S. Food & Drug Administration (FDA) began issuing a series of recalls for heart medication valsartan—most due to entire batches of the drug testing positive for N-Nitrosodiethylamine (NDEA), a chemical that can lead to liver damage, tumors and, with long-term exposure, dangerously low platelet counts.

Many more recalls have made recent headlines lately, and the growing list of recalled medications may be a result of increased scrutiny of drug manufacturers by the FDA. Scott Gottlieb, the FDA Commissioner, has said that dozens of chemists have been hired to review pharmaceutical companies with the goal of preventing dangerous or impure drugs from going onto the market. As of now, the FDA has not been able to concretely find the root cause of how the potentially carcinogenic contaminants were able to enter the medication during the manufacturing process.

What does this mean for the individuals who are taking any of these medications? Here’s the good news:

1. A majority of valsartan-containing drugs do not have the impurities. Many medications that contain valsartan have not been recalled at this time, simply because they were not created by the Chinese manufacturer that has tainted batches of it.
2. Even in the drugs that do contain impurities, the risk of getting cancer is extremely low. As per scientific estimates, approximately one additional case of cancer would occur if 8,000 people took the highest valsartan dose from a tainted batch every single day for four years. With that being said, it is important to continue taking any medication until speaking with a doctor, because the side effects of going off of it without guidance could be even more serious than the small risk of getting cancer.
3. Alternatives are available. Valsartan is not the only heart medications on the market. Currently, there are eight angiotensin receptor blocker (ARB) heart medications available on the market. These ARBs which include valsartan are all part of the same class of drugs, which means they can often be safely substituted for one another. Remember, however, to consult a doctor before making a change.

Luckily, the risk for serious harm is low, even for individuals who remain on the recalled medication while working on a new plan with their doctor. Even so, there is no acceptable level of exposure to these dangerous impurities, and patients with such conditions have enough troubles without damage done due to the negligence and oversight of large pharmaceutical manufacturers.

If you or a family member has been prescribed the drug valsartan and concerned about possible side effects, you should contact an attorney who is experienced in such matters to fully understand your legal options. Our law firm of Childers, Schlueter & Smith, LLC, is well-versed in drug and medical device litigation and might be able to help anyone who might have taken contaminated valsartan for any period of time. If you have questions, please give us a call at 1-800-641-0098. All initial inquiries are free of charge and without obligation.