Multiple pharmas pull ranitidine stomach drugs amid growing cancer scare
Supplies of the heartburn drug ranitidine have been recalled globally following a cancer scare involving multiple pharma companies, where a carcinogenic impurity is suspected to be present in the medicine.
Drugmakers such as Dr Reddy’s and GlaxoSmthKline have recalled their versions of the drug in some markets, and India’s Strides Pharma is the latest company to halt sales of the drug
The FDA alerted healthcare professionals to a voluntary recall of the over-the-counter drug available in Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp.
The regulator has previously called for recalls of ranitidine-based drugs from Sandoz, in the safety scare that has been building since mid-September when the FDA first raised concerns about the issue.
The FDA said the medicines may contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA), classed as a probable human carcinogen.
However the FDA has said that not all ranitidine medicines marketed across the US are being recalled, and the regulator is not recommending that people stop taking all ranitidine drugs at this time.
Ranitidine is known in some cases under the brand name Zantac and is used to prevent and relieve heartburn associated with acid ingestion and sour stomach.
The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called angiotensin II receptor blockers since last year.
The European Medicines Agency has also asked its CHMP scientific committee to issue guidance on avoiding nitrosamines in human medicines.
Earlier this month the EMA’s executive director Professor Guido Rasi said the regulator had also asked the committee to evaluate all available scientific evidence on the presence of nitrosamines in medicines and advise regulators on actions to take if companies find these chemicals in their medicines.
The CHMP will also consider whether to provide guidance for medicines other than those containing chemically synthesised active substances.
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