Nearly two dozen countries worldwide have announced a recall for generic Diovan, indicating that impurities were detected in the hypertension and heart drug that may cause cancer.
The valsartan recall was announced on July 5, after batches of the active ingredient, supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for N-nitrosodimethylamine (NDMA). The recall affects about 2,300 batches of valsartan and valsartan HCT shipped throughout Europe and Canada, but it does not appear the recalled medications were shipped in the United States.
The European Medicines Agency (EMA) issued a press release announcing a safety review of the drugs the same day the worldwide generic Diovan recall was announced.
“NDMA is classified as a probably human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the wat the active substance was manufactured,” the EMA press release states. “While the review is underway, national authorities across the EU are recalling the medicines containing valsartan supplied by Zhejiang Huahai.”
The review will look at the levels of NDMA found in valsartan and the potential health effects, as well as what can be done for patients who have taken them, and how future contamination can be prevented.
Officials in the U.S. Food and Drug Administration (FDA) have declined to say whether any of the batches were shipped to the United States, and are not recalling any valsartan at this time.
The FDA reviewed Diovan and similar medications in 2010, after some data suggested they may increase the risk of cancer. However, in 2011, the FDA reviewers indicated they could find no link between the drugs, known as angiotensin receptor blockers (ARBs) and cancer.
It is unclear whether the 2010 review and cancer concerns are connected in any way to last week’s recall. Valsartan was originally developed and sold by Novartis, and is now off-patent and sold as a generic.