May 9, 2020

FDA Approves Elyxyb Oral Solution for Migraines

The FDA has approved Elyxyb (celecoxib) oral solution for the acute treatment of migraine with or without aura. This drug is a nonsteroidal anti-inflammatory drug and is not indicated for the preventive treatment of migraine.

According to the FDA-approved drug label, the recommended and maximum dose of Elyxyb is 120 mg taken orally, with or without food. Elyxyb should be used for the fewest number of days possible per month on an as-needed basis.

Like all NSAIDs, Elyxyb can cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. These risks can increase with duration of use.

Furthermore, as an NSAID, Elyxyb may cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach of intestines, which can be fatal. These events can occur at anytime during use and without warning symptoms. Elderly patients and patients with a history of GI disorders are at greater risk of serious GI events.

For further information, read the FDA-approved drug label.

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