WASHINGTON, July 18 (UPI) -- The recent approval by the Food and Drug Administration of the "date-rape" drug GHB for the treatment of a rare form of narcolepsy raises concerns among drug abuse experts it could fall into the hands of young people wanting to abuse the drug.
"With the abuse potential so high and an already dedicated abuse population, this is a recipe for disaster," Carol Falkowski, a drug abuse researcher at the drug treatment research and education center Hazelden Foundation who was a member of the FDA advisory committee that recommended the drug for approval last year, told United Press International.
Falkowski said she has concerns that Xyrem -- the brand-name of GHB -- could become another Oxycontin, a prescription painkiller that adolescents in certain parts of the country have obtained illegally and abused. Xyrem was approved for the treatment of a condition called cataplexy, a rare condition experienced by some narcolepsy patients in which they lose muscular control. It can range from dropping of the jaw to collapse of the whole body.
GHB, which is classified by the Drug Enforcement Administration as a Schedule I drug -- a class that includes heroin, LSD and PCP -- is used by adolescents at parties and clubs. At low doses, it yields an effect similar to intoxication with alcohol but at higher doses it can cause breathing difficulties, coma and death.
The drug became known as the "date-rape" drug because of several documented cases where it had been given unsuspecting victims who were rendered unconscious and raped. Later, the drug induced memory difficulties that made it more difficult for the victims to recount their experiences and identify the attackers.
GHB was promoted in dietary supplements for enhancing sexual stamina and improving sports performance until the FDA banned it in 1990. Nevertheless, it continues to be readily available. Recipes for making the drug also can be found on the Internet and GLB, a precursor that the body will convert into GHB when ingested -- is found in industrial cleaning products.
Thomas Clark of Health and Addictions Research in Boston agreed with Falkowski, saying the drug has "considerable" potential for abuse.
"My guess is if this goes on the market, it will be (illegally used) to some extent just like any other drug that has a psychoactive effect usually is," he told UPI.
Due to concerns about the potential for abuse, the FDA has imposed tight restrictions to prevent the drug from falling into the wrong hands. These include allowing only one central pharmacy to distribute the drug and requiring doctors prescribing it and patients using it to register with a database.
Deborah Zvosec, a research investigator at the Minneapolis Medical Research Foundation who warned of the abuse potential of Xyrem at the FDA advisory committee meeting, called the restrictions "not strong enough." She added, "It's easy to get around these provisions."
However, Jane Maxwell, an epidemiologist at the University of Texas at Austin who monitors drug trends, said the restrictions imposed by the FDA will be adequate to prevent illegal use of the drug. In addition, she noted GHB and its precursors are readily available already, so there is little incentive for abusers to go through the rigamarole of obtaining Xyrem illegally.
Falkowski disagreed, saying a review of Web sites run by GHB abusers shows they have been monitoring Xyrem and "they have been waiting with bated breath for the availability of this drug in prescription form. The restrictions on prescribing may be unprecedented but I'm not convinced that they're enough to prevent another Oxycontin," she said, adding it would be easy to feign a sleep disorder and get a fraudulent prescription for the drug, just as people feigned pain and were able to obtain Oxycontin fraudulently.
Clark said abusers will be tempted to obtain Xyrem because it will be government-approved and regulated, meaning unlike illegal products on the street, the dosage and purity will be assured. "It's going to be pure and they know exactly how much they're going to take because it says it right on the bottle," he said. "That's why people like Oxycontin."
Zvosec noted addicts might try to obtain illegal prescriptions because it would cost much less than what they would have to pay on the street. She said she also has concerns about the potential for off-label use, a common, legal occurrence in the medical community in which doctors prescribe drugs for treatment of diseases other than which they were approved. The FDA's position always has been it does not regulate how doctors choose to prescribe drugs as soon as they enter the market.
If off-label use of Xyrem becomes commonplace, people could obtain the drug illicitly but easily by going to doctors who are less familiar with the abuse potential of the drug and feigning an illness, Zvosec said. Conditions for which Xyrem could be used off-label include insomnia. The drug also has been examined for treating dependence on alcohol and other drugs in Europe, she said.
Another avenue of abuse is as soon as the drug reaches the market "it would then be easy for people to get hold of Xyrem's containers and actually use them to disguise counterfeit and illegally-made GHB," Zvosec said.
Very little is known about the long-term effects of GHB, which raises concerns about the potential consequences not only among abusers but among patients who are legally using the drug to treat narcolepsy.
"There is absolutely no data on long-term chronic use of GHB," Zvosec said. Addicts have reported depression, anxiety attacks, tremor, numbness in extremities and neurological symptoms, but it remains uncertain whether this is due to GHB itself, she said.
The addictive potential of GHB also raises concerns that patients using the drug for legitimate purposes could become addicted to it. "A very significant portion of patients in clinical studies abused GHB," Zvosec said.
Orphan Medical, the manufacturer of Xyrem, did not return phone calls from UPI seeking comment by press time.
