The FDA slapped a new warning on Provigil, a drug for narcolepsy and other sleeping disorders made by Cephalon. The agency warned doctors of sensitivity reactions--including rare but potentially deadly Stevens-Johnson syndrome--and of psychiatric side effects like hallucination and suicidal thoughts.
Provigil is also approved for use against drowsiness in shift worker--and it's been used off-label by truckers, med students and other types who want to stay awake all night, or even two to three days at a time. One of its selling points? Few side effects.
- read the new warning [1] from the FDA
- see this story [2] from the Houston Chronicle
- read about off-label use [3] in Wired
Related Articles:
Cephalon shares tank after Sparlon (Provigil) rejection. Report [4]
FDA staffers question safety of Sparlon for ADHD. Report [5]
Positive Phase III results for Cephalon's Treanda. Report [6]
Cephalon takes heat for off-label narcotic promotion. Report [7]
Links:
[1] http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil
[2] http://www.chron.com/disp/story.mpl/ap/fn/5242343.html
[3] http://www.wired.com/wired/archive/11.11/sleep.html
[4] http://www.fiercebiotech.com/story/cephalon-shares-tank-after-sparlon-rejection/2006-08-10
[5] http://www.fiercebiotech.com/story/fda-staffers-question-safety-of-sparlon-for-adhd/2006-03-22
[6] http://www.fiercebiotech.com/story/positive-phase-iii-results-cephalons-treanda/2007-10-24
[7] http://www.fiercebiotech.com/story/cephalon-takes-heat-for-off-label-narcotic-promotion/2006-11-21