Sanofi to Withdraw Zantac After FDA Warns of Carcinogens

Sanofi SNY will have to withdraw its heartburn drug, Zantac, from U.S. markets, following FDA’s request.

The FDA has requested drugmakers marketing ranitidine, which is widely available by the brand name of Zantac, to immediately withdraw all prescription and OTC versions from the market. The FDA in its investigations observed that the ranitidine medications, which are approved for treating heartburn associated with acid indigestion, contain a carcinogenic contaminant, N-Nitrosodimethylamine ("NDMA").

Please note that in October 2019 Sanofi initiated a voluntary recall of all Zantac over-the-counter (“OTC”) versions — Zantac 150, Zantac 150 Cool Mint, and Zantac 75 — in the United States. The decision was made by the company as a precautionary measure following a public statement from the FDA in September, alerting about a possible contamination of ranitidine medications.

Due to recall of Zantac, Sanofi reported that sales of its Consumer Healthcare GBU declined 12.8% in the United States in the fourth quarter 2019. Complete withdrawal of the drug will further impact sales unfavorably in 2020. A few other generic drugmakers marketing ranitidine medications had also initiated voluntary recall of the drugs last year, including Perrigo PRGO and Lannett Company LCI.

Shares of Sanofi have lost 14.6% so far this year compared with the industry’s decrease of 11.1%.

Although low-levels of NDMA do not increase risk of cancer, the FDA has determined that NDMA in some ranitidine products increases with time and when medications are stored at higher than room temperatures. These can lead to consumer exposure to unacceptable levels of NDMA, which the agency states may cause cancer.

However, director of the FDA’s Center for Drug Evaluation and Research stated that though the agency had not observed unacceptable levels of NDMA in many of the samples that were tested, it was unsure of storage duration and conditions of the samples. Hence, as a precaution, the FDA decided that ranitidine medications should not be available to consumers and patients unless its quality can be assured.

With this withdrawal request, ranitidine medications will not be available for new or existing prescriptions or OTC use in the United States. The FDA has suggested alternative drugs for use, including famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (AstraZeneca’s AZN Nexium), lansoprazole (Takeda Pharmaceuticals’ Prevacid) or omeprazole (Prilosec). These medications are not found to contain NDMA.

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