FDA recalls high blood pressure, heart failure medication over cancer risk

Modesto Morganelli
Luglio 16, 2018

The FDA has announced a voluntary recall of several drugs that contain the heart drug valsartan because a possible carcinogen was found in the recalled products. There has been an impurity found in valsartan called N-nitrosodimethylamine (NDMA).

The human carcinogen NDMA is an organic chemical that is also used to make liquid rocket fuel, softeners, and lubricants.

According to the FDA, the presence of NDMA is these drugs was unexpected.

-Valsartan, manufactured by Teva Pharmaceuticals Industries Ltd. "This is why we've asked these companies to take immediate action to protect patients", Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said.

The FDA adds that patients taking recalled products for serious medical conditions should continue to take their medication until they have a replacement product. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", FDA Commissioner Scott Gottlieb, MD, said in the statement.

Valsartan is off patent and is used as a component of other generic medicines, but not all medicines containing the ingredient are involved, according to the FDA. "As we seek the removal of certain drug products today, our drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications".

To determine if you're medication has been recalled, look at the drug name and company name on the label of your prescription bottle.

Earlier this month, European authorities recalled drugs that had valsartan that were supplied by a Chinese drugmaker over concerns they may contain NDMA, as reported by Medscape Medical News. Pharmacies in the United Kingdom are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.

It could include another valsartan product not affected by this recall or an alternative treatment option. You should also follow the recall instructions provided by the specific company.

For more information, visit the FDA's website.

The FDA will continue to investigate this issue and provide additional information when it becomes available.

Altre relazioniGrafFiotech

Discuti questo articolo

Segui i nostri GIORNALE