As part of its ongoing efforts to reduce preventable adverse events from the products it regulates, the Food and Drug Administration (FDA) today announced that it is strengthening the controls designed to protect patients by restricting imports of certain prescription drugs that can be used safely only with specified controls in place.
FDA's action involves adding the drugs to an existing FDA Import Alert, which alerts FDA field personnel to the possible importation of these drugs, provides guidance as to their detention and refusal of admission into the United States, and also advises United States Customs personnel to refer any attempted importation to the local FDA field office.
The drugs added to the Import Alert are as follows:
- 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
- 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
- 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 arrhythmias
- 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
In a related action, FDA today alerted consumers not to buy these drugs over the internet, because drugs obtained via websites usually are not accompanied by these safety controls.