FDA announces more valsartan recalls, issues warning letter to API manufacturer
Pharmacists can monitor list of recalls that FDA is updating
The valsartan recalls continued this month when FDA alerted patients and health professionals that Teva Pharmaceuticals issued a voluntary recall of valsartan-containing products manufactured using active pharmaceutical ingredient (API) from Mylan Pharmaceuticals. Mylan voluntarily recalled valsartan-containing products in November 2018.
FDA said the valsartan investigation is ongoing and they will continue to test all angiotensin II receptor blockers (ARBs) for the presence of N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). The steps for synthesizing other ARBs are similar to those for valsartan.
In previous Pharmacy Today coverage of the recalls dating back to September 2018, FDA described the events that led up to the recall. In June 2018, U.S. manufacturer Prinston Pharmaceuticals Inc. had contacted FDA‘s Center for Drug Evaluation and Research to inform the agency that it had stopped manufacturing valsartan products because it had detected trace amounts of NDMA in valsartan API supplied by Chinese manufacturer Zhejiang Huahai Pharmaceutical (ZHP) Co. Although the amounts of NDMA that Prinston detected were small, FDA considers them to be unacceptable because NDMA is classified as a probable human carcinogen.
On December 11, 2018, FDA sent a warning letter to ZHP outlining its violations, including impurity control, change control, and cross contamination from one manufacturing process line to another. FDA said it was still looking into the root cause of the impurity.
“We’re continuing to investigate and take action to protect patient health and safety from products in this angiotensin II receptor blocker class that have been found to have dangerous impurities. As part of that investigation, we’ve uncovered serious manufacturing violations at ZHP, which is one of the manufacturing facilities that has been linked to these products. The issues cited in the warning letter are associated with the nitrosamine impurities found in these drugs, and these violations reveal a disturbing lack of oversight at this API manufacturer that puts patients at risk,” said FDA Commissioner Scott Gottlieb, MD, in the FDA statement.
FDA put ZHP on import alert back in September 2018, blocking all API from legally entering the United States.
FDA said that patients should continue taking their current medicine until their pharmacist provides a replacement or their health care provider can prescribe an alternative therapy.
“It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition,” said FDA.