FDA Issues Import Restrictions on 10 ‘Risky’ Rx Drugs
In an attempt to reduce unmonitored use of "particularly risky" prescription drugs, the FDA yesterday placed import restrictions on 10 medications and warned consumers not to purchase them via the Internet, the Wall Street Journal reports. The drugs were added to an existing "import alert" warning FDA and U.S. Customs Service workers to prevent the importation of the drugs (Adams, Wall Street Journal, 12/10). The following are the drugs on the list:
Accutane, or isotretinoin: An acne treatment;
- Actiq, or fentanyl citrate: Used to treat pain in cancer patients;
- Clozaril, or clozapine: Used to treat severe cases of schizophrenia in patients who do not respond to standard therapy;
Lotronex, or alosetron hydrochloride: Prescribed to women with irritable bowel syndrome;
- Mifiprex, or mifepristone: Prescribed for medical abortion;
- Thalomid, or thalidomide: Used for the treatment of skin sores;
- Tikosyn, or dofetilide: Prescribed for cardiac arrhythmias;
- Tracleer, or bosentan: Used to treat hypertension;
- Trovan, or trovafloxacin mesylate or alatrofloxacin mesylate injection: An antibiotic used to treat life-threatening infections in inpatient settings; and
- Xyrem, or sodium oxybate: Prescribed for the treatment of muscle weakness in patients with narcolepsy (FDA release, 12/9).
U.S. patients who purchase the listed drugs in other countries or via the Internet are less likely to have participated in "risk management" programs, according to the FDA (Adams, Wall Street Journal, 12/10). FDA Commissioner Mark McClellan said, "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 who might otherwise benefit from the drugs' use" (FDA release, 12/9). In related news, the House Energy and Commerce Committee Subcommittee on Oversight and Investigations tomorrow will hold a hearing on Accutane's side effects (Wall Street Journal, 12/10). This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.