[tt] Modafinil to carry warnings

[Hughes, James J.]

http://www.medpagetoday.com/ProductAlert/Prescriptions/dh/7108

Modafinil (Provigil) Will Carry Hypersensitivity Reaction Warning
			  	
By Peggy Peck, Executive Editor, MedPage Today

October 25, 2007

ROCKVILLE, Md., Oct. 25 -- The FDA said Cephalon has agreed to update
the modafinil (Provigil) label to include a warning about increased risk
of Stevens-Johnson syndrome and other serious rashes and
hypersensitivity reactions.

In a letter to physicians, Jeffrey M. Dayno, M.D., vice president for
medical services of Cephalon, warned that worldwide post-marketing
revealed rare cases of serious or life-threatening rash, including SJS,
toxic epidermal necrolysis, and drug rash with eosinophilia and systemic
symptoms in adults and children.

Moreover, multi-organ hypersensitivity reactions "including at least one
fatality in post-marketing experience, have occurred in close temporal
association to the initiation of modafinil," he wrote.

He said the drug should be stopped at the first sign of rash or other
hypersensitivity reaction, and patients should be advised to immediately
call their physicians.

Dr. Dayno also reminded clinicians that modafinil "is not approved for
pediatric patients for any indication" and that the drug can cause
psychiatric symptoms including anxiety, mania, hallucinations, and
suicidal ideation.

In clinical trials in pediatric patients, the rate of rash resulting in
discontinuation of the drug was about 0.8% (13 per 1,585), a rate that
included one confirmed case of SJS and one case of apparent multi-organ
hypersensitivity reaction. Also in the trials were several reported
cases of fever along with vomiting and leukopenia.

No serious rashes were reported in clinical trials of adults (0 per
4,264), according to Dr. Dayno.

Angioedema has also been reported in patients taking modafinil, and Dr.
Dayno said patients should be advised to immediately stop the drug if
they experience swelling of the face, eyes, lips, tongue, or larynx
and/or difficulty in swallowing, breathing, or hoarseness.

Modafinil is a central nervous system stimulant that is used for
treatment of sleep disorders such as narcolepsy and shift-work sleep
disorder. It is also used along with continuous positive airway pressure
(CPAP) devices to treat obstructive sleep apnea-hypopnea syndrome.