FDA Approves Celecoxib in an Oral Solution

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On May 6, the U.S. Food & Drug Administration (FDA) approved a 25 mg/mL dose of an oral solution of celecoxib (Elyxyb) to treat adults with acute migraine with or without aura.¹ Although not FDA approved to treat other types of pain, the non-steroidal anti-inflammatory drug (NSAID) possibly be used off label for pain management in patients unable to swallow solid dosage forms.

The solution carries the same boxed warnings as celecoxib (Celebrex) in its original capsule formulation.^2,3 These warnings include an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may occur early during use and may increase with duration of use. Like celecoxib in a capsule, the oral solution is also contraindicated in the setting of coronary artery bypass graft surgery. Additionally, NSAIDs cause an increased risk of serious gastrointestinal adverse events, such as bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events may occur at any time during use and without warning.

Elderly patients and patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding are at greater risk for these serious events.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Dr. Reddy’s Laboratories. News release: Dr. Reddy’s Laboratories received approval for their NDA, Elyxyb (celecoxib oral solution) 25 mg/mL, in the U.S. 2020 May 6.
2. U.S. Food & Drug Administration. Prescribing information eylxyb. 2020 May 5.
3. U.S. Food & Drug Administration. Prescribing information celebrex. 2019 May 3.