January 4, 2019
The U.S. Food and Drug Administration (FDA) has expanded its list of recalled drugs commonly used to treat high blood pressure and heart failure because they contain a possible cancer-causing agent.
This week Aurobindo Pharma USA announced a voluntary recall of 78 lots of valsartan tablets, and Torrent Pharmaceuticals expanded its voluntary recall of losartan potassium tablets to a total of 10 lots.
The ongoing recall applies to specific angiotensin II receptor blockers (ARBs) found to have trace amounts of the chemicals N-nitrosodiethylamine (NDEA) or N-nitrosodimethylamine (NDMA) above the acceptable daily intake levels.
NDEA was detected in these newly recalled drugs. The FDA describes it as “a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes.” The agency suspects that the carcinogens were introduced in the manufacturing operation.
“The drugs affected appear to be only ARBs, or combination drugs that include an ARB,” says Sarah Samaan, MD, a cardiologist with Baylor Regional Medical Center in Plano, Texas. “These are very effective and safe drugs in general, with few side effects, so they are widely used. We typically use them to treat blood pressure, but they may also be used for heart failure and kidney protection.”
ARBs work by blocking the action of angiotensin, a chemical in the body that narrows blood vessels, according to the Mayo Clinic.
What to Do if You’re Taking the Drug
The FDA stresses that patients taking a recalled ARB should continue taking their current medication until their pharmacist can offer a replacement drug or their doctor prescribes a different medication that treats the same condition.
“The risk of some sort sort of serious outcome from high blood pressure right now is the higher risk than the potential carcinogen effect of the contaminant,” says Michael Ganio, PharmD, director of pharmacy practice and quality at the American Society of Health-System Pharmacists in Bethesda, Maryland. “Having a stroke or some sort of cardiovascular event is very serious, and if patients stop taking their blood pressure medication without consulting their prescriber, they’re at risk for some sort of serious health event.”
Dr. Samaan advises that if a patient does need a replacement medication, their doctor will likely try to choose another drug in the same family.
“Since the drugs may take several weeks to reach the full effect, your blood pressure may be somewhat erratic at first,” she says.
How to Find Out More
This FDA recall of certain valsartan products and other ARBs began in July 2018, and the investigation is ongoing. The agency stresses that not all valsartan and related products are under recall, only specific lots. To keep up with news on which products are being recalled, consumers are advised to monitor the FDA website.
“I recommend if the patients have any questions at all, whether they think they are affected or not, the pharmacist is a very accessible resource for them and they should call their local pharmacist if they have any concerns about their medication,” says Dr. Ganio.
To get a better understanding of the scope of the problem, the FDA encourages patients and healthcare providers to report any adverse events related to these drugs to its MedWatch program.
“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market,” said Scott Gottlieb, MD, FDA Commissioner, in a statement. “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.”