March 21, 2023

FDA Approves Combogesic for Short Term Management of Mild to Moderate Pain

The FDA recently approved Combogesic® (acetaminophen and ibuprofen) tablets for the short term management of mild to moderate acute pain. This approval is for a single tablet that contains 325 mg of acetaminophen and 97.5 mg of ibuprofen.

Both acetaminophen and ibuprofen are common drugs used for pain management in workers’ comp. This new medication could see utilization in workers’ comp, and as a new brand drug may incur higher costs when generic medications are readily available.

According to the FDA-approved drug label, Combogesic features similar warnings that respectively come with acetaminophen and ibuprofen products.

Acetaminophen can be associated with cases of acute liver failure, usually when doses of acetaminophen exceed 4,000 milligrams per day, often involving more than one acetaminophen containing product. Like any NSAID, Combogesic can cause increased risk of serious cardiovascular thrombotic events, and serious gastrointestinal adverse events.

The drug label states that the lowest effective dosage for the shortest duration should be used, and that this product should not be used with other acetaminophen-containing products. Up to three tablets every six hours may be used, up to a maximum of 12 tablets a day.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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