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FDA warns about 'stay awake drug' Provigil

Published on October 28, 2007 at 7:38 PM · No Comments

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.

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