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Antibiotic Drug List

BETHESDA, Md. -- The Food and Drug Administration last month strengthened its controls on imports of certain prescription drugs- adding 10 branded medicines to its PD A Import Alert program. The program alerts field personnel to the possible importation of drugs on the list, provides guidance to United States' Customs personnel and advises border guards to refer any attempted importation to the local FDA field office.

FDA commissioner Mark McClellan has set the reduction of preventable adverse events as a major FDA priority. "Use of these FDA-approved products without adequate controls or monitoring and using versions of these products not approved by the FDA increases the risk of serious adverse events for patients," he stated.

In a related action, the FDA urged consumers not to buy these drugs, or any medicines for that matter, over the Internet because the safety and efficacy of the pharmaceutical product cannot be guaranteed.

Although importing unapproved prescription drugs is illegal, the FDA's official guidance on importing drugs for personal use "recognizes that there ma y be circumstances in which the FDA can exercise discretion to not take action against the illegal importation," a September/October 2002 article from the FDA Consumer magazine reads. However, the exception was designed to afford people with serious conditions a condoned choice of treatments should the drug in question not be readily available in the United States.

Controls on medications on the Import Alert list include limiting the distribution of the drugs to specific facilities (such as hospitals), limiting their distribution to physicians with special training or expertise or requiring certain medical procedures (such as pregnancy testing or blood testing) with their use.

The drugs added to the Import Alert are: Accutane (isotretinoin), indicated against severe acne; Actiq (fentanyl citrate), for severe cancer pain in patients who are tolerant to opioid therapy; Clozaril (clozapine), which manages severe schizophrenia; Lotronex (alosetron hydrochloride), for women with severe cases of irritable bowel syndrome; Mifiprex (mifepristone), an abortion pill also called RU486; Thalomid (thalidomide) indicated for the treatment of leprosy; Tikosyn (dofetilide), a maintenance regimen for people with irregular heartbeats; Tracleer (bosentan), which treats severe pulmonary hypertension; the antibiotic Trovan (trovafloxacin mesylate); and Xyrem (sodium oxybate), which treats patients with narcolepsy.

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