FDA Issues Recall on Valsartan Due to Impurity

The FDA has issued a recall on several common drugs that contain an ingredient called valsartan, including several which are used to treat high blood pressure and heart failure. The recall was issued recently due to an “impurity” that’s classified as a probable carcinogen based on lab results.

The impurity is a substance known as “N-nitrosodimethylamine” or “NDMA” for short. Trace amounts of the substance were found in valsartan from manufacturers Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries. In total, medicines sold by more than two dozen names and companies are affected by the recall.

The FDA took action after 22 other countries issued a recall of their own on more than 2,000 batches of valsartan. According to a news release from the organization, the NDMA’s presence is believed to have been an “unexpected” result of changes in the way valsartan is manufactured.

Valsartan is an extremely important ingredient because it’s off-patent, which means it can be used in a wide variety of generic drugs. However, not all generic drugs that use this ingredient are involved in the recall. Likewise, the recall does not affect name-brand drugs. The FDA’s drug shortages team is working to ensure that patients who depend on these drugs will be have an adequate supply of drugs without this impurity until the manufacturing flaw can be corrected.

Experts offered four important pieces of advice for patients in the wake of this drug recall:

• Not all valsartan drugs are affected by the recall
• Valsartan alternatives are available
• The cancer risk from exposure to NDMA is unknown and depends largely on the size and frequency of the exposure
• Taking medicines is not a good substitute for lifestyle changes when it comes to your overall health

Alternatives for these drugs offer valsartan, sometimes in combination with another ingredient known as amlodipine. It seems that many of these and several other drugs were not affected by the impurity and are therefore safe to continue use. If you have any questions, it’s highly advised you speak with your doctor to find out if the medication you’ve been taking is part of the recall.

Your Rights in Defective Drug Cases

Pharmaceutical companies have a duty of care to ensure that the products they release to the market are safe for consumption and have no negative consequences that could jeopardize the health of the people they are prescribed to. Despite this duty and often rigorous and repeated testing, dangerous or defective drugs can reach the market. When this happens, you as the consumer have the right to hold them responsible for the damages their product causes if you suffer negative effects from it.

In order to file a defective drug case, you must show that you have taken the drug, you suffered negative health effects by taking the drug, and that the health effects you experienced can be directly attributed to your use of the affected medicine. Doing so isn’t always the easiest task, which is why it’s strongly advised that you speak with a Baltimore defective product attorney.