There have been 3 drug regulatory agency warnings on Provigil from two countries (United States and United Kingdom). These are as follows:
United States, October 01, 2010: The FDA added “aggression” to the warning section of Provigil’s package insert. Source: “Provigil (Modafinil) tablets,” FDA Center for Drug Evaluation and Research, October 2010.
United Kingdom, August 01, 2010: The UK published new information in their Drug Safety Update newsletter about the European Medicines Agency decision regarding the stimulant Modafinil (Provigil). The agency has concluded that in the risks of the drug outweighed any type of benefit shown in clinical trials for any indication, save narcolepsy. Therefore it should NOT be used for any other treatment (except for narcolepsy), i.e. excessive sleepiness, “shift work sleep disorder”, etc. Source: “Modafinil: European Medicines Agency recommends restricted use,” MHRA, Drug Safety Update, Volume 4, Issue 1, August 2010.
United States, September 01, 2007: The Vice President of Medical Services at the drug company Cephalon sent out a letter to health care professionals informing them of new warnings for the company’s stimulant Provigil. “Updated Safety Information: Warnings regarding serious rash, including Stevens Johnson Syndrome [a life-threatening condition affecting the skin] and hypersensitivity reactions, and psychiatric symptoms. 1. Provigil can cause life-threatening skin and other serious hypersensitivity reactions… 2. Provigil is not approved for use in pediatric patients for any indication. 3. Provigil can cause psychiatric symptoms” including anxiety, mania, hallucinations, and suicidal ideation. Source: Jeffrey M. Dayno, M.D., “Dear Healthcare Professional,” Cephalon, September 2007.
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