The sleep-disorder drug, Provigil, by Cephalon Inc.(NASDAQ:CEPH) will soon carry more severe warnings on its packaging. The U.S. Food and Drug Administration has decided that the drug must now include warnings of life-threatening rashes and psychiatric symptoms.
Prescribing information must now include warnings of rare skin rashes, including Stevens-Johnson Syndrome, which can be deadly. Also the possibility of hallucinations, mania, anxiety and suicidal thoughts must be included.
It has been expected that Provigil would have to increase the strength of the warnings due to the fact that Nuvigil, a long acting version of the drug, was approved, in June, with stronger warnings.
The company has already sent letters to doctors to apprise them of the changes in labeling.
Provigil and Nuvigil are indicated for use with patients that suffer from narcolepsy, obstructive sleep apeana/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).
[Source: Bloomberg]
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