HYDERABAD, Sept 22: 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.Reddys is still evaluating potential impact of the
issue. As a precautionary measure, Dr Reddys 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 Reddys spokesperson told PTI in
an email reply.
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 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 Reddys 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 USA market following the alleged cancer
causing impurity-NDMA. (PTI)
Follow our WhatsApp channel
