- Novartis' Sandoz unit this week said it is recalling its prescription ranitidine capsules in the U.S. after confirming contamination with the carcinogen N-Nitrosodimethylamine, or NMDA.
- The move builds on the Swiss drugmaker's decision last week to stop distribution of the drug around the world and to recall it in Canada. Now, it's asking pharmacies and stores in the U.S. to return their supplies of the heartburn drug, commonly known under its brand name Zantac.
- GlaxoSmithKline, meanwhile, confirmed that it initiated a voluntary recall of Zantac products manufactured with active ingredient sourced from Saraca Laboratories and Dr Reddy's in countries where the British pharma giant sells the drug. GSK does not supply ranitidine in the U.S.
Moves by Novartis and GlaxoSmithKline to curtail distribution of ranitidine product, which is sold in generic form by many different drugmakers, may be just the beginning.
Canadian regulators last week asked all companies selling the medicine in the country to stop shipping the drug, saying "current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer."
The contaminant, NMDA, has already wreaked havoc on supplies of a group of generic blood pressure medicines known as sartans. After impurities were first detected, regulatory warnings spread and a steady drip of recalls began, with the latest coming just this month, according to a running tally kept by the Food and Drug Administration.
NMDA is a known environmental contaminant and may be present in low levels in food and water. The FDA in January said it believes that chemical reactions in drug manufacturing may have caused the higher levels of carcinogen contamination in the sartan drugs.
The agency has been racing to cope with the issue. When the heart treatment contamination was first found, the FDA didn't have its own test, according to Bloomberg. Now, the regulator has posted testing protocols and is asking companies to do laboratory testing on NDMA in ranitidine.
"We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking the medicines they need without concern," acting FDA Commissioner Ned Sharpless said in a statement yesterday.