A possible human carcinogen has been found in heart failure and blood pressure medications distributed across the U.S., leading three companies to voluntarily recall their products. The U.S. Food and Drug Administration (FDA) explained in an announcement on July 13, 2018, that some medications containing the active ingredient valsartan have been contaminated with N-nitrosodimethylamine (NDMA), a substance that may cause cancer. Not all medications containing valsartan are part of the blood pressure medication recall, however, only those believed to be tainted with NDMA.
The companies participating in the blood pressure medications recall are Teva Pharmaceuticals Industries Ltd., Prinston Pharmaceutical (also known as Solco Healthcare), and Major Pharmaceuticals. According to the FDA, a change in the way valsartan is manufactured is believed to have led to the contamination of the medications with NDMA. The announcement noted that the agency is investigating both the potential effects on consumers as well as methods of eliminating future contamination of the medication.
“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,” FDA Commissioner Scott Gottlieb, M.D., said in a press release.
Consumers who are currently taking heart failure or blood pressure medications that may be part of the recall are being advised to continue taking the medication until they obtain a replacement.
“Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” the recall announcement by Prinston Pharmaceuticals noted.
The FDA suggests that patients check their prescription bottles for manufacturer information to determine whether their specific medication has been recalled. If the information is not on the label, they should contact the pharmacy where the prescription was filled to learn whether or not it is part of the recall.
The three pharmaceutical companies involved in the recall are also reaching out to retail pharmacies and hospitals as well as wholesalers to check their inventory and remove any products included in the recall. Patients and physicians are asked to work together to determine suitable replacements for the blood pressure and heart failure medications until the situation is resolved.
According to the FDA, the original source of the contamination is valsartan supplied to the three companies by a Chinese manufacturer. Zhejiang Huahai Pharmaceuticals, of Linhai, China, distributed the NDMA-tainted valsartan to all three companies. The distribution has since ended and officials are working to remove it from the supply chain. The FDA notes that other pharmaceutical companies did not use valsartan supplied by Zhejiang Huahai Pharmaceuticals, and therefore those valsartan-based medications are not part of the recall.
The three U.S. companies affected by the recall are not the only ones believed to have received a tainted supply from the China-based Zhejiang Huahai Pharmaceuticals. In May of 2018, the European Medicines Agency announced a recall of heart failure and blood pressure medications containing valsartan tainted with NDMA. Zhejiang Huahai Pharmaceuticals was also identified as the supplier in the European recall.
Patients who need more information or help in determining whether their medication is part of the recall are being urged to contact their pharmacist and doctor. More information, including the recall announcements listing the specific batch numbers of the recalled medication is available on the FDA website at www.FDA.gov.