Zantac Generic Pulled From Markets World Wide
By John Gever Managing Editor, MedPage Today
One manufacturer of generic ranitidine (Zantac), Novartis’s Sandoz unit, has reportedly decided to halt distribution of the antacid drug until a contamination issue is resolved.
Last week, the FDA said some lots of ranitidine, a histamine H2 inhibitor, were found to contain small amounts of N-nitrosodimethylamine (NDMA), considered to be a human carcinogen. NDMA is a member of the nitrosamine family of chemicals also found to have contaminated some angiotensin receptor blocker drugs, sparking an uproar that still hasn’t died down.
Ranitidine is sold in both prescription and over-the-counter (OTC) forms primarily to relieve ratinidine,gastroesophageal reflux and for gastric and intestinal ulcer prevention. The FDA didn’t indicate which particular products were affected since they are not being recalled at this time; the generic drug is available from other companies besides Sandoz.
Although no recall was ordered, the FDA said last week that patients using OTC ranitidine “could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”
Patients taking prescription ranitidine who wish to switch to another medication should consult their physicians, the FDA said.