According to the U.S. Food and Drug Administration (FDA), Duexis — a single-tablet combination product containing ibuprofen, a nonsteroidal anti‐inflammatory drug (NSAID), and famotidine, a histamine H2–receptor blocker — will no longer be manufactured.

Duexis is indicated to treat pain and inflammation associated with osteoarthritis (OA) and rheumatoid arthritis (RA), as well as to reduce the risk of developing upper gastrointestinal ulcers.

According to available information, the decision to no longer manufacture Duexis and the generics (listed below) was business-related and not related to safety, quality, efficacy or an imposed recall.

Impact on workers’ compensation and auto no-fault

Although OA and RA are conditions not typically caused by a workers’ compensation or auto injury, ibuprofen and famotidine may be used to treat pain and inflammation due to other causes. According to treatment guidelines, Duexis is not recommended as a first-line therapy for either of these conditions. In addition, brand-name Duexis and its generics cost more than the single-ingredient products in non-combination form.

A review of transactional data from our book of business revealed low utilization of Duexis, and the generic ibuprofen-famotidine products manufactured by Horizon, Lupin, and Teva.

Until supplies of these products have been exhausted, they may still be dispensed at a pharmacy. Alternatively, patients may obtain a prescription for generic ibuprofen-famotidine product distributed by another manufacturer (e.g., Ascend Laboratories, Camber Pharmaceuticals) or obtain them as separate products – ibuprofen and famotidine – available over-the-counter (OTC) or by prescription.

Patients should contact their prescriber or health care provider if they have any questions about ongoing use of ibuprofen and famotidine.

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:

1. FDA Drug Shortages. Ibuprofen and Famotidine Tablets. Horizon Therapeutics (8/17/2023) and Teva Pharmaceuticals (1/25/2023). Available at: FDA Drug Shortages.
2. ODG by MCG Treatment Guidelines [database online]. Ibuprofen/Famotidine. An MCG Health Company. Last updated April 1, 2022. Accessed on September 5, 2023.
3. Duexis (ibuprofen-famotidine) package insert. Horizon Therapeutics; 2021. Available at. Duexis Package Insert.