Zantac - MHRA drug alert issued as GlaxoSmithKline recalls all unexpired stock

Packages and pills of Zantac seen

Packages and pills of Zantac seen

GlaxoSmithKline GSK.L on Tuesday said it is recalling the popular heartburn medicine Zantac in all markets as a "precaution", days after the U.S. Food and Drug Administration found "unacceptable" levels of probable cancer-causing impurity in the drug.

Around 6 million prescriptions for ranitidine had been issued in England final twelve months, essentially based completely on NHS Digital.

The four products affected are Zantac 150mg/10ml Syrup, Zantac 50mg/2ml Injection, Zantac 150mg Tablets and Zantac 300mg Tablets - all of which are prescription-only medicines.

Over-the-counter products that also bear the Zantac name are made by a different company and are unaffected, the MHRA said.

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.

"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".

"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".

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.

United Kingdom doctors are being told to stop prescribing four types of a heartburn medication called Zantac or ranitidine as a "precautionary measure". Canada's health authorities have also asked makers of the drug to halt distribution as they gathers more information.

The impurity was believed to have been introduced by changes in the manufacturing process.

Notícias recomendadas

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.