Novartis halts distribution of ranitidine products, generic for Zantac®, as precaution during investigation of possible contamination

August 19, 2019 · Optum for Workers' Compensation

On September 18, 2019, Novartis announced it is stopping the distribution of its Sandoz division’s ranitidine, generic for Zantac®, until further notice. This decision was made as a result of the U.S. Food and Drug Administration (FDA) statement on September 13 that low levels of a human carcinogen were found in some ranitidine products. While the FDA has not officially recalled any ranitidine products, Novartis has decided to stop distributing its ranitidine products in all markets as a precaution while the contamination, and potential risk to patients, is being further investigated.

Availability and impact on workers’ compensation

Classified as a histamine (H2) blocker, ranitidine may be prescribed in workers’ compensation for the treatment and prevention of multiple conditions, including heartburn, ulcers and gastroesophageal reflux disease (GERD), secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Generic ranitidine has been commercially available for over twenty years. It is available over-the-counter and by prescription in several strengths and formulations. While Novartis is the only company, at this time, to halt distribution of its products, there are over twenty other manufacturers or distributors of ranitidine, such as Teva, Mylan, Perrigo and Major Pharmaceutical.

There is a minimal impact on our book of business for claimants using ranitidine products by Sandoz. If a claimant currently taking ranitidine has questions related to this situation, they should talk to their healthcare professional to determine if transitioning to another generic ranitidine product or a different medication in the same class, such as famotidine and nizatidine, is appropriate.

For more information from Novartis, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

Medpage Today®. Zantac Generic Pulled From Markets Worldwide. September 18, 2019. Available at: https://www.medpagetoday.com/gastroenterology/gerd/82238?xid=NL_breakingnewsalert_2019-09-18.
U.S. Food and Drug Administration. FDA Statement. Statement alerting patients and health care professionals of NDMA found in samples of ranitidine. September 13, 2019. Available at: https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine.