Multiple pharmas pull ranitidine stomach drugs amid growing cancer scare

Ranitidine hydrochloride is commonly used for treatment of ulcers of stomach and intestine

Ranitidine hydrochloride is commonly used for treatment of ulcers of stomach and intestine

The recall follows the company's announcement last week that it would halt shipments of the stomach-acid-reducing drugs.

Strides said the product will be manufactured at Alathur facility in Chennai and will be marketed by Strides Pharma in the USA market.

While the drug, popularly indicated for acidity, has been sold without any issue in pharmacies so far, companies that have it in their over-the-counter portfolio as well as Active Pharmaceutical Ingredients (APIs) are still evaluating the impact.

However the FDA has said that not all ranitidine medicines marketed across the United States are being recalled, and the regulator is not recommending that people stop taking all ranitidine drugs at this time. And Sanofi, which produces the brand-name Zantac, is not yet making any moves.

South Korea's health authorities said Thursday that they will suspend the manufacturing and sales of some ranitidine drug products that contain a probable human carcinogen.

For now, the FDA is investigating ranitidine products from numerous manufacturers, including Sandoz Inc., to see "whether low levels of NDMA recently discovered in ranitidine pose a risk to patients".

The approved product is a generic version of Vesicare tablets of Astellas Pharma US, Inc.

NDMA is one of three cancer-causing substances identified in widespread recalls of the blood pressure and heart medications losartan, valsartan and irbesartan since July 2018.

"As advised in our earlier notification to the Stock Exchanges on September 25, 2019, Strides has received an Information Request (IR) from the USFDA to provide test data related to Nnitrosodimethylamine (NDMA) impurities in Ranitidine tablets".

That prompted the ministry to halt the import, production and sale of all brand-name and generic drugs containing ranitidine. Saraca Pharma, another Hyderabad-based, API maker, has also been featured in reports.

" Additionally, the U.S. Food and Drug Administration (FDA) is urging anyone now taking the recalled ranitidine "to follow the recall instructions provided by Sandoz".

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