A few months ago, the U.S. Food and Drug Administration (FDA) recalled several generic blood pressure medications manufactured by Mylan Pharmaceuticals. Since then, over 104 lots of valsartan tablets and valsartan-combo tablets have been recalled. Regulators have found that the often-prescribed heart drug actually contains a carcinogen.
The three medicines that have been recalled thus far include valsartan tablets, valsartan with hydrochlorothiazide and valsartan with amlodipine. When the FDA recall was originally announced, they noted that those medications were found to contain trace amounts of N-nitrosodiethylamine (NDEA), a chemical that is known to cause cancer. Drinking water and foods in areas that have high levels of industrial waste and air pollution have routinely tested positive for this particular carcinogen.
Since the recall was first announced, the FDA has been working diligently to identify the origin of this contamination. So far, regulators have honed in on a few different Chinese and Indian factories where many of the generic drug makers got their valsartan supply from. The FDA has issued an "import alert," prohibiting the drugs from suspect manufacturers from entering the U.S.
Although an FDA spokesperson notes that they've determined that the defective drug was distributed in this country from March 2017 through November 2018, she says that they've begun testing all "sartan" medicines for potential contamination. Diovan, which is a brand-name drug produced by the manufacturer Novartis, has yet to test positive for any carcinogen.
She also noted that since this contamination was initially discovered a few months ago, regulators would have expected the need for recalls to decrease by now. She says this hasn't been the case though.
The spokesperson also points out that while patients may be motivated to stop taking their medication over the recalls, they shouldn't. Doing so can put their health in further jeopardy. Instead, this recall should prompt patients to talk with their doctors about alternative therapies and the adverse symptoms that they may be experiencing instead.
Most consumers assume that any medication on the market has been thoroughly tested and is safe for use by the time it is given to them. The truth is that many pharmaceutical companies fail to disclose known side effects that may put an individual's life in danger. That failure can leave patients with serious injuries and is nothing short of negligence.