The discovery that certain ranitidine medicines contained N-nitrosodimethylamine (NDMA), a probable carcinogen, was made by online pharmacy Valisure and disclosed to the US Food and Drug Administration (FDA) by a Citizen Petition, last month.
Following this, various companies have issued voluntary recalls, national regulators have recommended withdrawal of certain products from the market, and lawsuits have begun on behalf of consumers.
The treatment itself is commonly used for gastrointestinal conditions, such as heartburn, indigestion, and gastric ulcers.
Sanofi begins voluntary recall
The latest two companies to voluntarily recall their products from the market are Dr Reddy’s and Sanofi.
The latter company has recalled its branded Zantac over-the-counter (OTC) product, which is the most identifiable ranitidine-based product, after having arrived on the market in 1981 and establishing itself as one of the best-selling drugs of all time, with $97.4bn (€87.5bn) in lifetime sales, according to EvaluatePharma.
Sales have since slowed down, with it now being off-patent, but the drug brought in approximately $128m during 2018 for Sanofi.
Sanofi explained that it had voluntarily withdrawn the product from the US and Canada as a ‘precautionary measure’ due to the potential for contamination with NDMA.
Outside of these countries, Sanofi will continue to sell the treatment, as it specified that the active pharmaceutical ingredients (APIs) are sourced from different suppliers to the product delivered to the US and Canadian markets.
A spokesperson for Sanofi was not immediately available for comment.
Dr Reddy’s joins move to issue recalls
Dr Reddy’s announced yesterday that it had initiated a voluntary nationwide recall in the US on October 1, at the retail level for OTC products and at the consumer level for prescription products.
The action was taken after the company confirmed that the FDA had discovered contamination of its ranitidine products, with NDMA levels above what is deemed acceptable by the agency.
Dr Reddy’s recall involves all of its ranitidine medicines sold in the US.
