FDA Issues Warning Update on "Stay-Awake" Drug, Provigil
The U.S. Food and Drug Administration (FDA) and pharmaceutical manufacturer, Cephalon, have notified physicians of a change to the warning which accompanies Provigil -- a drug used in the treatment of narcolepsy and obstructive sleep apnea. The drug has recently been linked to life-threatening skin infections and other serious hypersensitivity reactions, as well as to adverse psychiatric symptoms, such as anxiety, mania, hallucinations, and suicidal ideation.
The warning states that patients using Provigil should discontinue its use if they experience any of these symptoms, and contact their physician immediately. The warning also advises that Provigil is not approved for use in children for any reason.
The warning comes one month after the FDA issued a warning related to Cephalon's Fentora, a cancer pain medication linked to unexplained overdoses.
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- An FDA warning regarding Cephalon's cancer pain medication, Fentora
- 54 prescription drugs that recently received warning label updates or corrections
- Heart-imaging drugs that the FDA has linked to injuries and fatalities
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