Federal regulators are warning consumers of a shortage of certain blood pressure medications, amid recalls of the drugs due to a low cancer risk.
Angiotensin II receptor blocker, or “ARB,” medicines treat high blood pressure and heart failure. Generic versions of the drug, including valsartan, irbesartan, losartan and others, have been recalled in recent months following the discovery of potentially cancer causing impurities in them.
The recalls are beginning to make themselves felt, the FDA announced last week.
“Valsartan products are in shortage, and we know that other types of products may fall into shortage soon,” the FDA said in a statement Friday, Jan. 25.
The FDA said it was informed last summer that some medication ingredients manufactured by a particular Chinese pharmaceutical company were tainted. The FDA’s subsequent investigation has led to the recall of a number of drugs containing “probable carcinogens,” chemicals NDMA and NDEA.
The FDA has now placed an import alert on all products manufactured by Zhejiang Huahai Pharmaceuticals, meaning anything produced by the company won’t be allowed into the country.
The risk to patients taking these medications of actually contracting cancer is low, the FDA said, but “this doesn’t diminish the significance of this episode or our concerns.” FDA scientists estimate that 8,000 people taking the highest daily dose of valsartan tainted with NDMA for four years would produce one extra case of cancer beyond the average rate.
“While consumers should limit exposure to NDMA and NDEA,” the FDA said, “these impurities exist in other ingested products, such as some charcoal grilled food items.”
The FDA is telling patients to continue taking the recalled drugs until their pharmacists provide alternative medications or their doctors prescribe other treatments.
“[Our] goal,” the FDA said, “is to balance the risk of patients ingesting low levels of the impurities…with the risk that there is a shortage of certain ARBs, which may impact patients’ ability to access the medicine they need.”
The FDA’s full statement can be read here.
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