U.S.
Food and Drug Administration
FDA Consumer magazine
January-February 2002
Table
of Contents
|
Drug Name |
Use |
Risks |
Date Approved |
Manufacturer |
|---|---|---|---|---|
|
2001 |
||||
|
Baycol (cerivastatin) |
Cholesterol drug |
Risk of rhabdomyolysis, severe damage to muscle that is sometimes fatal, especially when used at a high dose or with another drug called gemfibrozil |
1997 |
Bayer Pharmaceutical Division, West Haven, Conn. |
|
Raplon (rapacuronium bromide) |
Injectable anesthesia drug administered as a muscle relaxant for breathing tube placement and surgery |
Risk of bronchospasm, an inability to breathe normally that can lead to permanent injury or death |
1999 |
Organon Inc., West Orange, N.J. |
|
2000 |
||||
|
Lotronex (alosetron) |
Treatment for irritable bowel syndrome in women |
Risk of intestinal damage resulting from reduced blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of severe constipation) |
2000 |
Glaxo Wellcome Inc. (now GlaxoSmithKline), Research Triangle Park, N.C. |
|
Propulsid (cisapride) |
Treatment for nighttime heartburn |
Risk of fatal heart rhythm abnormalities |
1993 |
Janssen Pharmaceutica Inc., Titusville, N.J. |
|
Phenylpropanolamine |
Decongestant used in many prescription and over-the-counter cough and cold medications |
Risk of hemorrhagic stroke (bleeding in the brain) |
** |
** |
|
Rezulin (troglitazone) |
Treatment for type 2 diabetes |
Risk of severe liver toxicity |
1997 |
Parke-Davis/Warner Lambert, Morris Plains, N.J. |
|
1999 |
||||
|
Hismanal (astemizole) |
Antihistamine |
Risk of fatal heart rhythm abnormalities when used with other drugs or at too high a dose |
1988 |
Janssen Pharmaceutica Inc. |
|
Raxar (grepafloxacin) |
Antibiotic |
Risk of fatal heart rhythm abnormalities |
1997 |
Glaxo Wellcome Inc. (now GlaxoSmithKline) |
|
1998 |
||||
|
Posicor (mibefradil) |
Treatment for high blood pressure and chronic stable angina |
Risk of dangerous interactions with other drugs |
1997 |
Roche Laboratories, Nutley, N.J. |
|
Duract (bromfenac) |
Pain reliever |
Risk of severe liver damage |
1997 |
Wyeth-Ayerst Laboratories, Philadelphia |
|
Seldane (terfenadine) and Seldane-D |
Antihistamine |
Risk of fatal heart rhythm abnormalities |
1985 |
Hoechst Marion Roussel, Kansas City, Mo., and Baker Norton Pharmaceuticals, Miami |
|
1997 |
||||
|
Pondimin (fenfluramine) |
Treatment for obesity |
Risk of heart valve abnormalities |
1973 |
Wyeth-Ayerst Laboratories |
|
Redux (dexfenfluramine) |
Treatment for obesity |
Risk of heart valve abnormalities |
1996 |
Wyeth-Ayerst Laboratories |
** Phenylpropanolamine was in use prior to 1962, when an amendment to food and drug laws required a review of the effectiveness of this and other drugs while they remained on the market. It was deferred from final approval because of safety concerns about a possible association between phenylpropanolamine use and an increased risk of stroke. Based on previous case reports of stroke and data from a recent safety study, the FDA is proposing to remove phenylpropanolamine from the market.
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