Dermatologic implications cited in new warnings for Modafinil

Dermatology Nursing, Feb, 2008 by Daniel B. Burfeind

Pavlovich-Danis, S.J. (2007, December 3). New warnings for Provigil: Dermatologic implications. Nursing Spectrum.

The Food and Drug Administration (2007) has issued new precautions and labeling changes for modafinil (Provigil[R]). Modafinil is a psychostimulant to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep disorder, hypopnea (shallow breathing) syndrome, shift work sleep disorder, and fatigue in patients with multiple sclerosis.

Modafinil has been associated with Stevens-Johnson's syndrome (SJS) and toxic epidermal necrosis (TEN). These diseases are severe forms of erythema multiforme, which is usually caused by a drug reaction, infection, or illness. SJS/TEN causes mucosal erosions with widespread erythematous, cutaneous macules, or target lesions that merge together with subsequent epidermal detachment.

Modafinil has also been associated with hypersensitivity, angioedema, drug rash with eosinophilia, and systemic symptoms, both in adults and children. Psychiatric symptoms including anxiety, mania, hallucinations, and suicidal ideation have been reported in patients taking modafinil therapy.

Patients must be given careful skin examinations when modafinil therapy is initiated or dosages adjusted. Benign rashes may also occur, but it is not possible to predict which may be serious and which may not. Patients should be advised to report any rashes and discontinue their modafinil therapy and see their health care provider. Patients should also be educated on the signs and symptoms for angioedema and anaphylaxis; swelling of the face, eyes, lips, tongue or larynx, difficulty in swallowing or breathing, and hoarseness. Patients and their families need to observe the patient for mood swings and/or behavioral changes, especially in those patients with a history of psychosis, depression, or mania.

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Reference

Food and Drug Administration. (2007). Provigil product information. Retrieved February 5, 2008, from http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil

Daniel B. Burfeind, RN, DNC, is a Nurse Educator, ICS/AmerisourceBergen, Cookstown, NJ; and a Dermatology Nursing Editorial Board Member.