Dr Reddy's halts worldwide supply of Ranitidine
Dr Reddy's Laboratories Limited on Sunday said that it is suspending supply of its drug Ranitidine worldwide as a precautionary measure
Hyderabad: Dr Reddy's Laboratories Limited on Sunday said that it is suspending supply of its drug Ranitidine worldwide as a precautionary measure, following the ongoing probe by the US Food and Drug Administration into the reported impurity N-nitrosodimethylamine in it at low levels.
Ranitidine is an Over-The-Counter (OTC) 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 said.
The FDA in a statement on September 13 had said it is working with international regulators and industry partners to determine the source of this impurity in Ranitidine being manufactured by several companies RPT being manufactured by several companies 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 US 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.