The drugs on this list have important benefits, but they also have serious known risks. As a result, they are available in the U.S. only under specially created safety controls. If these drugs are bought over the Internet or from foreign sources, these safety controls are bypassed, placing patients who use these drugs at higher risk. In addition, drugs bought from foreign sources are generally not FDA approved.
- Accutane (isotretinoin) - indicated for the treatment of severe recalcitrant nodular acne.
- Actiq (fentanyl citrate) - indicated for the management of severe cancer pain in patients who are tolerant to opioid therapy.
- Clozaril (clozapine) - indicated for the management of severe schizophrenia in patients who fail to respond to standard drug treatments for schizophrenia.
- Humatrope (somatropin for injection) - indicated for the treatment of non-growth hormone-deficient short stature.
- Lotronex (alosetron hydrochloride) - indicated for the treatment of severe irritable bowel syndrome in women.
- Mifiprex (mifepristone or RU-486) - indicated for the medical termination of early intrauterine pregnancy.
- Plenaxis (abarelix for injectable suspension) - indicated for the treatment of advanced symptomatic prostate cancer in men who are not able to receive other types of treatment.
- Thalomid (thalidomide) - indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum.
- Tikosyn (dofetilide) - indicated for the maintenance of normal sinus rhythm in patients with certain cardiac arrhythmia.
- Tracleer (bosentan) - indicated for the treatment of severe pulmonary arterial hypertension.
- Trovan (trovafloxacin mesylate or alatrofloxacin mesylate injection) - an antibiotic administered in in-patient health care settings for the treatment of severe, life-threatening infections.
- Xyrem (sodium oxybate) - indicated for the treatment of cataplexy in patients with narcolepsy.
U.S. Department of Health and Human Services
Food and Drug Administration