FDA to Stop 10 Drugs at Borders
Don't Buy These Risky Drugs on Internet, Outside U.S.
Dec. 10, 2002 -- Ten prescription drugs must be detained at U.S. borders if people buy them abroad. The medications -- which include Accutane and the IBS drug Lotronex -- are too risky for unsupervised use, according to the FDA.
The action reflects the government's effort to control "adverse events from the products it regulates," says an FDA news release.
It also adds teeth to an already-existing FDA Import Alert, which informs FDA field personnel when these drugs may be imported. Under this action, anyone trying to import the drugs may be detained and refused admission to the U.S.
In a related advisory, the FDA also alerted consumers not to buy these drugs over the Internet. Drugs obtained via web sites usually are not accompanied by these safety controls.
There is real concern about the safety risks posed by use of any of these products, says the FDA release.
The following drugs are covered by the FDA's Import Alert:
- Accutane (isotretinoin) - for the treatment of severe acne.
- Actiq (fentanyl citrate) - for the management of severe cancer pain in patients who are tolerant to opioid therapy.
- Clozaril (clozapine) - for the management of severe schizophrenia in patients who fail to respond to standard drug treatments for schizophrenia.
- Lotronex (alosetron hydrochloride) - for the treatment of severe irritable bowel syndrome in women.
- Mifiprex (mifepristone or RU-486) - for the medical termination of early pregnancy.
- Thalomid (thalidomide) - for the acute treatment of leprosy.
- Tikosyn (dofetilide) - for the maintenance of normal sinus rhythm in patients with certain heart rhythm abnormalities.
- Tracleer (bosentan) - for the treatment of severe pulmonary arterial hypertension.
- Trovan (trovafloxacin mesylate or alatrofloxacin mesylate injection) - for the treatment of severe, life-threatening infections.
- Xyrem (sodium oxybate) - for the treatment of extreme muscular weakness in patients with narcolepsy.
SOURCE: News release, FDA