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Cyprus remembers heartburn medicine, possible cancer link



The pharmaceutical services on Friday called on all medications containing ranitidine as a precautionary concern for cancer relatedness.

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

Animal tests showed that a particular drug, NDMA, had possible links to cancer.

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

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

The decision to stop distribution is the lead until the European Medicines Agency determines the drug's safety, authorities said.

who regularly takes the medication should seek advice from the doctor or pharmacist about alternative medication.

The US and European drug regulators last week said they reviewed the safety of ranitidine after finding evidence of a probable carcinogenic impurity in some versions of the drug.

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

The impurity of ranitidine was first flagged to the regulators by Valisure, a online pharmacy that tests the medicine it sells for deficiencies.

In its report, Valisure said it found impurities in both Sanofi SA's brand 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 ̵

1; and lower – amounts of NDMA in the drugs.

David Light, CEO of Valair, said the company believes that because ranitidine is unstable, the impurity can be formed on its own, rather than being introduced by problems in the production process. He said it is possible that the impurity has been in the fabric as long as it has been on the market.

"There seems to be an inherent problem with the drug itself," Light said in an interview. "There are many concerns that in our minds justify remembering this product completely."

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

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

The regulators have remembered these substances since last year, and the FDA expanded its investigation of impurities beyond that drug class last month. [19659002]


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