FDA warns about 'stay awake drug' Provigil

Oct 28 2007

The U.S. Food and Drug Administration (FDA) has issued a warning in connection with the drug Provigil because of dangerous side effects.

Provigil which is made by drug manufacturer 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 and see their doctor if they develop a skin rash or other hypersensitivity reaction.

According to government scientists negative side effects have included instances of Stevens-Johnson Syndrome, which begins as a red rash but can eventually cause skin to peel off the body, resulting in deadly infections.

It seems most cases of the disorder occurred 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 Provigil.

Psychological problems generally stopped within 36 hours of discontinuing use of Provigil.

Provigil is also sometimes used for performance enhancement by the military for pilots and soldiers in combat situations as the medication enhances short-term memory and enables users to stay awake for extended periods of time.

Provigil was approved by the FDA in 1998 for the treatment of excessive daytime sleepiness associated with narcolepsy but is also used by many for "off-label" uses.

These include age-related memory decline, attention deficit disorder, depression, fatigue from high-pressure jobs, chemotherapy and multiple sclerosis, and for memory problems associated with Alzheimer’s disease, post-anesthesia grogginess, sleepiness caused by other prescription medications and as a treatment for cocaine addiction.

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).

It is one of Cephalon's biggest-selling products.

Doctors 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.

Cephalon's experimental new drug Nuvigil, which is also used to treat excessive sleepiness was approved by the FDA in June, and already carries similar warnings.

The labeling change comes less than one month after the FDA issued a warning on another Cephalon drug, Fentora, which is a used to treat extreme pain in cancer patients; the FDA said several patients had accidentally overdosed on the drug while using it for non approved uses.