FDA STRENGTHENS CONTROLS, ISSUES CONSUMER ALERT
ON IMPORTING CERTAIN PRESCRIPTION DRUGS

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. FDA is concerned about the safety risks posed by use of any of these products without the specified controls in place.

The revised Import Alert and the consumer advisory are available online at http://www.fda.gov/ora/fiars/ora_import_ia6641.html and http://www.fda.gov/oc/buyonline/consumeralert120902.html
respectively.

Although these drugs have important benefits for many patients, they have serious known risks and so are available in the U.S. only under specially created safety controls. These safety controls are bypassed when these drugs are purchased from foreign sources, placing patients who use these imported drugs at higher risk. Therefore, because of this higher risk to patients, FDA took action to further curtail the products' availability from foreign sources. The drugs purchased from foreign sources are generally not FDA-approved.

Controls on these prescription drugs include limiting their distribution 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.

Commissioner of Food and Drugs Mark B. McClellan, M.D., has set as a major FDA priority the reduction of
preventable adverse events. "The FDA is committed to taking action, through educational activities and other means where necessary, to improve patient safety," said Dr. McClellan. "Use of these FDA-approved products without adequate controls or monitoring, and using versions of these products not approved by FDA, increases the risk of serious adverse events for patients who might otherwise benefit from the drugs' use."

According to a 1999 report by the Institute of Medicine, medical errors in hospitals alone cause annually 40,000-98,000 deaths. The IOM has estimated that preventable adverse events cost the United States economy $17 billion a year.

Detailed information for consumers and patients who would like to learn more about how to buy prescription drugs safely may be found in FDA's guide, "Buying prescription Medicines Online: A Consumer Safety Guide," available online at http://www.fda.gov/cder/drug/consumer/buyonline/guide.htm

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