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21 Sep 2019
Cyprus recalls heartburn drug, possible cancer link

The pharmaceutical services on Friday recalled every medication containing ranitidine as a precautionary measure over concern of its link to cancer.

The detection of low levels of a probable carcinogen called NDMA in ranitidine was announced by the US watchdog FDA last week.

Tests on animals showed that a particular substance, NDMA, had possible links to cancer.

Ranitidine is used to block stomach acid, and is commonly taken for heartburn.

The products available in Cyprus that contain ranitidine were Zantac tablets, Zantac injection, Ranitidine Accord tablets, Lumaren tablets, Lumaren injection and Verlost oral solution.

The decision to stop its distribution is precautionary until the European Medicines agency determines the drug’s safety, the authorities said.

Patients who regularly take the medicine should seek the advice of their doctor or their pharmacist for alternative medication.

U.S. and European drug regulators last week said they were reviewing the safety of ranitidine after they found traces of a probable cancer-causing impurity in some versions of the medicine.

The U.S. Food and Drug Administration said it had found traces of the impurity, called N-nitrosodimethylamine (NDMA), in some of drugs with ranitidine in them.

The impurity in ranitidine was first flagged to the regulators by Valisure, an online pharmacy that tests the medication it sells for flaws.

Valisure said in its report that it found the impurity in both Sanofi SA’s branded Zantac as well as generic versions of the drug, Reuters reported. But the FDA would not confirm in which versions of the drug it had found the impurity, noting that it found quite different – and lower – amounts of NDMA in the drugs.

David Light, Valisure’s chief executive officer, said his company believes that because ranitidine is unstable, the impurity can form on its own, rather than being introduced by problems in the manufacturing process. He said its possible that the impurity has been in the drug for as long as it has been on the market.

“It seems to be that there’s an inherent problem with the drug itself,” Light said in an interview. “There’s a lot of concerns that, in our mind, justify completely recalling this product.”

The FDA said it has not determined how long the impurity has been present in Zantac.

NDMA is one of the impurities that has been found in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs). Those impurities are believed to have been introduced by recent changes in the manufacturing processes for ARBs.

Regulators have been recalling those drugs since last year, and the FDA expanded its investigation of the impurities beyond that class of drugs last month.

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