Tuesday, October 19, 2021
HomeWeekly RoundupMore countries and companies recall heartburn drug Zantac

More countries and companies recall heartburn drug Zantac

US retailer CVS has become the latest to suspend the sale of a heartburn drug being investigated for links to cancer. BBC News reports that it follows concern in several countries over the presence of impurities in Zantac and other ranitidine products. Canada and France have already announced Zantac recalls. The US and the EU are investigating.

Health authorities say there is no immediate risk, but patients have been advised to consult a doctor who can prescribe alternatives to ranitidine.

On 13 September, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published their decisions to review the presence of N-nitrosodimethylamine (NDMA) in medicines containing the drug ranitidine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies.

NDMA is found in water and foods, including meats, dairy products, and vegetables, but is not expected to cause harm when ingested in very low levels, EMA says.

CVS's announcement on Saturday said it was suspending the sale of Zantac and CVS Health brand ranitidine products "out of an abundance of caution".
"Zantac brand products and CVS brand ranitidine products have not been recalled, and the FDA is not recommending that patients stop taking ranitidine at this time," the company said. Walgreens, Walmart and Rite Aid in the US had earlier taken a similar decision.

Canada and France have removed the drugs from pharmacy shelves. A number of other countries have followed suit. Bangladesh on Sunday issued a temporary ban on the import, production and sale of ranitidine while it investigates the links to cancer.

The report says drug makers are also recalling products containing NDMA. Sandoz, owned by Novartis, said it was recalling "several batches of its ranitidine-containing medicines". The recalls were "under way or pending" in Australia, Austria, Belgium, Canada, Croatia, the Czech Republic, Denmark, Finland, Germany, Hungary, North Macedonia, Portugal, Slovakia, Slovenia, Sweden, Switzerland and the US.
Apotex also said it was recalling ranitidine tablets in the US.

But, the report says, health regulators are urging people taking ranitidine not to discontinue it immediately. The FDA said, however, that those taking it by prescription should contact health professionals about alternatives. And those buying it over the counter could consider other options.

South Africans are advised to return any heartburn medicines containing ranitidine. And, says an eNCA report, all marketing of the products has been banned in South Africa.

The local Health Products Regulatory Authority says 20 companies are affected in South Africa. Mlungisi Wondo, from the SA Health Products Regulatory Authority, said, "we told them not to release any products they are having and then also quarantined with companies that were affected." "Sandos decided to recall on their own immediately. We don't want to release the products until we know the root cause."

However, the report says, the authority has sought to allay the fears of patients here. Wondo said, "we take the contamination very serious hence minimising the products from the owners, they mustn't release, it's important to start with healthcare providers that they know and substitute, there is a lot of products in that range, on the patients side we will request they must go back to their healthcare workers to substitute."

[link url="https://www.bbc.com/news/health-49868852"]BBC News report[/link]

[link url="https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine"]FDA statements[/link]

[link url="https://www.enca.com/life/sa-advised-return-ranitidine-heartburn-medicine"]eNCA report[/link]

Subscribe to our Newsletter

Receive Medical Brief's free weekly e-newsletter.

* indicates required