Dr. Reddy's Laboratories Limited. said that it is suspending supply of its drug Ranitidine worldwide as a precautionary measure, following the ongoing probe by the U.S. Food and Drug Administration into the reported impurity N-nitrosodimethylamine in it at low levels.
Ranitidine is an Over-The-Counter and prescription drug which decreases the amount of acid created by the stomach.
"Dr. Reddy's is still evaluating potential impact of the issue. As a precautionary measure, Dr. Reddy's is suspending all shipments worldwide of Ranitidine products until the investigation by the FDA outcome is available.
We have both a prescription and an over-the-counter portfolio of the product," Dr. Reddy's spokesperson told PTI in an email reply.
The FDA in a statement on Sept. 13 had said it is working with international regulators and industry partners to determine the source of this impurity in Ranitidine and examining levels of NDMA in Ranitidine and evaluating any possible risk to patients.
Though the FDA is not calling for individuals to stop taking Ranitidine at this time, however, patients taking the prescription and wishing to discontinue its use should talk to their health care professionals about other treatment options, the U.S. drug regulator said.
"We expect to provide an update in the coming days. The FDA is not calling for individuals to stop taking Ranitidine at this time.
Consumers and health care professionals should report any adverse reactions with Ranitidine to the FDA's MedWatch program to help the agency better understand the scope of the problem," Dr. Reddy's said.
The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines such as Valsartan since last year.
Aurobindo Pharma, Torrent Pharmaceuticals, Hetero Labs and many other multinationals have voluntarily recalled Valsartan from the U.S. market following the alleged cancer causing impurity-NDMA.
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