trending Market Intelligence /marketintelligence/en/news-insights/trending/mTJauurKtUj-pViDB4_9TA2 content esgSubNav
In This List

Zantac, generics under review in EU, US after cancer-causing impurity discovered

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Zantac, generics under review in EU, US after cancer-causing impurity discovered

Popular stomach medicine ranitidine, marketed by French drugmaker Sanofi as Zantac, is being reviewed by U.S. and EU regulators after tests showed that some of these products contained a potentially cancer-causing impurity.

Ranitidine drugs, which are also available as generics, are used to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers.

The European Medicines Agency, which is carrying out the review at the request of the European Commission, said some ranitidine medicines contained an impurity called N-nitrosodimethylamine, or NDMA, a probable human carcinogen.

The EMA and U.S. Food and Drug Administration are evaluating the data to assess whether patients using ranitidine are at any risk from the presence of NDMA, and both agencies will provide updates when available. The EMA noted that alternatives to ranitidine are available to treat the same conditions.

Separately, the FDA said it is working with international regulators and industry partners to determine the origin of the impurity. The U.S. is not, at this time, asking patients to stop taking the medicine, but recommended that patients taking a prescription version of the drug should talk to their physicians if they have any concerns.

NDMA and similar compounds known as nitrosamines were found in several blood pressure medicines known as "sartans" in 2018, sparking global recalls and investigations. Several companies like Teva Pharmaceutical Industries Ltd., Mylan NV and Major Pharmaceuticals, Inc., among others, voluntarily recalled certain high blood pressure and heart medicines containing the compounds. Strict new manufacturing requirements were later set for these medicines.

The EMA noted in its Sept. 13 press release that the agency is working on guidance for avoiding nitrosamines in other classes of medicines.