FDA Tries To Plug Loophole For Risky DrugsDec 11, 2002 | AP The government is ordering 10 prescription drugs to be detained at the U.S. border if patients buy them abroad instead of through their doctors, calling the medications too risky for unsupervised use.
At issue are drugs ranging from the acne treatment Accutane to a version of the date-rape drug GHB that is used to treat narcolepsy. All can cause serious side effects and thus are allowed to sell in the United States only under severe restrictions, such as curbs on which doctors can prescribe them and what patients qualify.
But the Food and Drug Administration noticed Internet advertisements for some of the drugs that entice patients to order the medications directly, ignoring the safety restrictions.
It is illegal to sell prescription drugs without a doctor's valid prescription, so the FDA is taking steps to shut those Web sites and warned consumers Monday not to buy the drugs in question over the Internet. Because some of the Web sites are foreign, the FDA also asked U.S. Customs officials to seize shipments of the drugs from abroad.
"This is a loophole we're seeking to plug," said FDA drug chief Dr. Janet Woodcock.
Drugs cited in Monday's warning include:
• Accutane, or isotretinoin, for severe acne.
• Actiq, an oral version of the painkiller fentanyl for severe cancer pain.
• Clozaril, for schizophrenia.
• Lotronex, for women with severe irritable bowel syndrome.
• Mifiprex, the abortion pill also called RU-486.
• Thalomid, a brand of the notorious birth defect-causing drug thalidomide that treats leprosy.
• Tikosyn, also called dofetilide, for certain irregular heartbeats.
• Tracleer, for severe pulmonary hypertension.
• Trovan, an antibiotic also called trovafloxacin or alatrofloxacin.
• Xyrem, a version of the date-rape drug GHB that prevents a complication of narcolepsy.
The FDA doesn't know of anyone harmed by buying the drugs underground, but notes that patients likely wouldn't volunteer that information to the government.
Woodcock, however, urged patients to remember these drugs have "special risks. Getting them outside of the health care system puts people at even higher risk for severe harm."