High Carcinogen Levels Cause More Drug Recalls
The series of recalls of ranitidine (also known as Zantac) and nizatidine products grew longer with three US Food and Drug Administration (FDA) announcements on Tuesday and Wednesday.The 150 mg and 300 mg versions of the stomach acid treatment from New Jersey-based generic drugmaker Appco Pharma are being recalled. In addition, Denton Pharma and Northwind Pharmaceuticals also recalled all unexpired lots of ranitidine tablets, 150 mg and 300mg versions. Mylan on Wednesday also recalled three lots of the ulcer treatment nizatidine (including the 150mg and 300mg strengths).
All of the recalls are due to higher-than-acceptable levels of N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. To date, Appco has not received any adverse event reports related to use of the product. Northwind said in its recall that it has ceased distribution of its ranitidine products in the US while the manufacturer continues its efforts to test and investigate in cooperation with the FDA.
FDA previously announced the voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart and Rite-Aid and manufactured by Apotex Corp. Similarly, Sandoz announced a voluntary recall of 14 lots of prescription ranitidine capsules.
“Although many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in November, explaining the impurity levels the agency found.
Ranitidine products from Sandoz, Aurobindo and Dr Reddy's, for instance, were found to exceed the acceptable daily intake limit for NDMA, while ranitidine products from Strides Shasun and Watson did not, according to FDA’s analysis. Similar recalls have occurred in the UK too.
By 26 April, the European Medicines Agency is calling on companies to conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome and fill out either the template indicating “no risk identified” or “risk identified.”
FDA previously said some of the NDMA levels in the ranitidine medicines “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
Appco Recall and Denton and Northwind Recall and Mylan