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Europe, Canada start recall of Zantac drug versions after carcinogen scare

Bloomberg September 19 | Updated on September 19, 2019 Published on September 19, 2019

The series of actions is aimed at getting contaminated drugs off pharmacy shelves   -  ajt

Drugmakers and global public-health regulators are taking steps to remove supplies of a popular heartburn medication that may have become tainted with a cancer-causing agent from the market.

Novartis AG’s Sandoz unit said on Wednesday that it was halting worldwide distribution of generic versions of the stomach drug Zantac, just days after regulators in the US and Europe began investigating the discovery of a likely human carcinogen called NDMA, or N-Nitrosodimethylamine, in the medications.

Some versions of Zantac, which is also known by the generic name ranitidine, have also been recalled in Europe and Canada as well.

The moves are the latest in a series of actions aimed at getting drugs tainted with potentially deadly contaminants off pharmacy shelves. Since last year, the US Food and Drug Administration (FDA) has been overseeing a recall of a type of generic blood-pressure pills that originated in China and India and were contaminated with NDMA.

On Friday, the FDA and Europe’s top drug regulator said that they were examining NDMA levels in Zantac and its generic forms and whether they pose any risk to patients. Ranitidine is taken by millions of people worldwide to treat gastrointestinal disorders and discomfort. Sandoz is one of several generic-drug makers that distribute it. French drugmaker Sanofi makes branded Zantac sold without a prescription.

“A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the US,” said Eric Althoff, a spokesman for Novartis.

Some countries in the European Union are recalling ranitidine containing an active ingredient made by an India-based manufacturer, Saraca Laboratories Ltd, said Germany’s Federal Institute for Drugs and Medical Devices in a statement.

Published on September 19, 2019
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