PROVIGIL is a medication that has the active ingredient of Modanifil and is used to treat excessive sleepiness caused by certain sleep disorders. These sleep disorders are narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. In addition to its wakefulness-promoting effects, PROVIGIL produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other central nervous system stimulants.
Cephalon, the manufacturers of PROVIGIL, changed the drug's label in September 2007 to include warnings regarding the occurrence of serious and life-threatening rashes, including Stevens-Johnson Syndrome ("SJS") and Toxic Epidermal Necrolysis ("TEN"), hypersensitivity reactions, and psychiatric symptoms associated with its use.
We are investigating cases in which individuals have experienced any of the following side effects associated with the use of PROVIGIL (Modafinil):
A serious rash or serious allergic reaction
Skin rash, hives, sores in the mouth or skin, blisters and peels, swelling of the face, eyes, lips, tongue, or throat, trouble swallowing or breathing and hoarse voice.
Mental (psychiatric) symptoms
Suicidal ideations or suicide attempts
If you or a loved one has taken Provigil and experienced and of the side effects associated with the use of PROVIGIL (Modafinil) should call us toll free now at 1-866-374-0338 because you may be entitled to compensation from the manufacturer.
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FDA adds warning to Cephalon's Provigil sleep drug
Wed Oct 24, 2007 4:44pm EDT
WASHINGTON, Oct 24 (Reuters) - A warning is being added to Cephalon Inc's (CEPH.O: Quote, Profile, Research) drug Provigil for excessive sleepiness because of the risk of serious skin rash and psychiatric symptoms, the U.S. Food and Drug Administration said on Wednesday.
Provigil is used to treat adults with narcolepsy and obstructive sleep apnea who have difficulty staying awake. Provigil is one of Cephalon's biggest-selling products with global sales of $415 million in the first half of 2007.
The warning means patients should stop using Provigil and see their doctor if they develop a skin rash or other hypersensitivity reaction, the FDA and Cephalon said in a joint statement posted on the regulatory agency's Web site.
Physicians should also use caution when prescribing Provigil for patients with a history of depression or mania because of potential side effects such as hallucinations and suicidal thoughts, the agency said.
"Rare cases of serious or life-threatening rash" have been reported in some adults and children taking the drug, the FDA said. Some cases of angioedema, a swelling beneath the skin similar to hives, have also been reported.
A similar warning is already required for Cephalon's experimental new drug Nuvigil, which is also to treat excessive sleepiness. The company won FDA approval for that drug in June.
Provigil 
