09 October 2019 10:48
Heartburn medicine pulled by GlaxoSmithKline while it investigates source of impurity GlaxoSmithKline is recalling the popular heartburn medicine Zantac in all markets, days after the US Food and Drug Administration (FDA) found "unacceptable" levels of probable cancer-causing impurity in the drug. Zantac, also sold generically as ranitidine, is the latest drug in which cancer-causing impurities have been found. Britain's medicines watchdog said GlaxoSmithKline (GSK) was recalling four prescription-only Zantac medicines – a syrup, an injection and tablets of 150mg and 300mg dosages – over an potential carcinogen called N-nitrosodimethylamine (NDMA) Over-the-counter 75mg dosage Zantac products are produced by a different company and are not affected by the recall, it added. "GSK informed the MHRA [Medicines and Healthcare products Regulatory Agency] of our decision to suspend the release, distribution and supply of all dose forms of Zantac products," a company spokesman confirmed to Reuters. The MHRA said healthcare professionals were told on Monday to stop supplying the products immediately, quarantine all remaining stock and return it to their supplier.
"We are advising that patients should not stop taking their medication, and do not need to see their doctor until their next routine appointment but should seek their doctor's advice if they have any concerns," the MHRA said. US and European health regulators said last month they were reviewing the safety of ranitidine, after online pharmacy Valisure flagged the impurities. The FDA said Valisure's higher-temperature testing method generated very high levels of NDMA from the ranitidine drugs. The US regulator has asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency. Last week, Walmart joined pharmacy chains CVS Health Corp, Walgreens Boots Alliance Inc and Rite Aid Corp in suspending the sale of over-the-counter heartburn drugs containing ranitidine.
However, the recall is a precautionary measure and the MHRA is advising that patients who have been prescribed Zantac do not need to stop taking their medication. Over-the-counter products are produced by a different company so are not affected by this recall. Dr Andrew Gray, for MHRA said: "Whilst this action is precautionary, the MHRA takes patient safety very seriously. "Patients should keep taking their current medicines but should speak to their doctor or pharmacist if they are concerned and should seek their doctor's advice before stopping any prescribed medicines. "We have asked companies to quarantine batches of potentially affected medicines whilst we investigate and we will take action as necessary, including product recalls where appropriate.
In September, three months after Valisure first alerted the FDA to its findings, the agency issued a safety alert, saying its own testing found "low levels" of NDMA in Ranitidine. It is now calling those levels "unacceptable," and told CBS News it is now investigating what happens to Ranitidine inside the body after it's exposed to stomach acid. "What we've been petitioning for is for the complete recall of all Ranitidine products — brand, generic doesn't matter — doesn't matter who made it or what lot number it is," Light said. Zantac's maker, Sanofi, told CBS News that Mitch's study has limitations and that the company is working closely with the FDA and doing its own "robust testing." While Zantac is still being sold, some generic makers have issued voluntary recalls. Pharmaceuticals giant GlaxoSmithKline has issued an urgent recall of a popular heartburn and stomach ulcer medicine over contamination fears of a chemical linked to cancer. The Department of Health's Medicines and Healthcare products Regulatory Agency (MHRA) sent an alert to healthcare professionals calling for all unexpired stocks of four types of Zantac to be returned. The recall is due to possible contamination of ranitidine, the active substance in the medication which reduces stomach acid levels, with an impurity linked to the development of certain cancers. However, doctors and pharmacists have been told to stop supplying the product immediately and to return all remaining stock to their supplier. Over-the-counter products that also bear the Zantac name are made by a different company and are unaffected, the MHRA said. The MHRA is investigating possible contamination of other ranitidine medicines and said it would provide updates as the investigation progresses. It asked manufacturers to quarantine all ranitidine products which may contain the active pharmaceutical ingredient potentially affected by the issue. Dr Andrew Gray, MHRA deputy director of inspections, enforcement and standards, said: "Whilst this action is precautionary, the MHRA takes patient safety very seriously. "Patients should keep taking their current medicines but should speak to their doctor or pharmacist if they are concerned and should seek their doctor's advice before stopping any prescribed medicines." He added: "Currently, there is no evidence that medicines containing nitrosamines have caused any harm to patients, but the agency is closely monitoring the situation, and working with other regulatory agencies around the world."