Provigil® (generic modafinil) is being linked to dangerous skin reactions, which has prompted the Food and Drug Administration (FDA) to issue a warning in connection with the drug's dangerous side effects.
Provigil®, manufactured by Cephalon, is used to treat people suffering from narcolepsy and obstructive sleep apnea and stops them falling asleep at random times during the day.
The FDA says patients should stop using Provigil® (modafinil) and contact their health care provider if they develop a skin rash or any other hypersensitivity reaction.
Serious side effects caused by Provigil® include Stevens-Johnson Syndrome (SJS), erythema multiforme (EM), and toxic epidermal necrolysis (TEN) all which can lead to serious illness and even death.
It seems most cases of a skin reaction occur within five weeks of patients starting therapy with Provigil®.
The FDA also warns that there have been reports of hallucinations, anxiety, and suicidal thoughts linked to the use of modafinil.
Provigil® was approved by the FDA in 1998 for the treatment of excessive daytime sleepiness associated with narcolepsy.
Provigil® is the only FDA-approved prescription medicine for treatment of excessive sleepiness associated with Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) and Shift Workers Sleep Disorder (SWSD).
Physicians are also warned about prescribing Provigil® for patients with a history of depression or mania because of potential side effects such as hallucinations and suicidal thoughts.
If you or someone you know has taken Provigil® (modafinil) and experienced serious skin reactions such as Stevens Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN), please use this form on the left to contact one of our attorneys.











