THURSDAY, July 18, 2002 (HealthDayNews) -- One person's poison is another person's banquet.
In an approval process that requires the imposition of the strictest use and availability guidelines ever, the U.S. Food and Drug Administration has approved the marketing of a banned "date-rape" drug to treat narcolepsy, a rare sleep disorder.
Xyrem (sodium oxybate or gamma hydroxybutyrate) is also known as GHB, and it was a popular party drug in the late 1990s because it easily dissolved in drinks and created a feeling of euphoria. It also may have contributed to hundreds of overdoses and almost 60 deaths, according to government statistics.
The FDA said approval was given after clinical trials showed improvement in narcolepsy symptoms among a significant number of 448 patients.
Narcolepsy is a sleep disorder affecting about 150,000 people in the United States. It can cause an individual to "drop off" to sleep during a conversation, while driving a car or while performing any type of daily activity. The sleeping condition can last anywhere from a few seconds to many minutes.
However, the most unusual aspect of this particular drug approval is how difficult it will be to get Xyrem, even after you have a doctor's prescription. You won't be able to have it filled at your local pharmacy. Here's how the FDA describes the fulfillment process:
"Under the program, prescribers and patients will be able to obtain the product only through a single centralized pharmacy."
"The pharmacy will send Xyrem to patients only after their doctors have provided instruction on the safe and effective use of the drug, and after the patients have read the information provided about the drug."
"Doctors will also be urged to see their patients at least every three months. Doctors are also expected to report all serious adverse events to the manufacturer (Orphan Medical Inc. of Minnetonka, Minn.)."
Here is the FDA Talk Paper announcing Xyrem approval.
More information
How dangerous is GHB as a party drug? This information from the University of Washington describes GHB's contribution to rape, overdoses and death on college campuses.
This isn't the first time the FDA has approved a banned drug for another use. In 1998, the agency approved thalidomide for the treatment of certain types of leprosy. Thalidomide had been banned because when taken by pregnant women, it caused deformities in their babies.
