Provigil Warning!!!

For all of you that have been prescribed Provigil (modafinil) for MS-
related fatigue: the FDA has issued a warning that Provigil has been
linked to serious skin rashes and psychiatric symptoms.

Instead of me trying to restate these warnings, I give you this,
straight from the FDA letter:

a.. Skin rashes: "Rare cases of serious or life-threatening rash,
including SJS (Stevens-Johnson Syndrome), Toxic Epidermal Necrolysis
(TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)
have been reported in adults and children in worldwide post-marketing
experience. The reporting rate of TEN and SJS associated with
modafinil use, which is generally accepted to be an underestimate due
to underreporting, exceeds the background incidence rate. Estimates
of the background incidence rate for these serious skin reactions in
the general population range between 1 to 2 cases per million-person
years."

b.. "Psychiatric adverse experiences (including anxiety, mania,
hallucinations, and suicidalideation) have been reported in patients
treated with modafinil. Caution should be exercised when PROVIGIL is
given to patients with a history of psychosis, depression, or mania.
If psychiatric symptoms develop in association with PROVIGIL
administration, consider discontinuing PROVIGIL."

Bottom line: Contact your doctor if you are on Provigil and concerned
(and IMMEDIATELY contact your doctor if you experience ANY sort of
unusual rash or mood changes while taking Provigil).

Wednesday October 31, 2007

http://ms.about.com/b/2007/10/31/provigil-warning.htm