Drugs removed from the U.S. market July 1999-2008
| Drug | Indication | Benefits | Risks |
| Hismanal (astemizole) 1988-1999 H1-receptor antagonist | Treats symptoms of chronic idiopathic urticaria and seasonal allergic rhinitis | insignificant amount of sedation; extremely long duration of action. | fatal heart arrhythmias (torsades de pointes) while taking high doses or while taking certain other drugs that increase blood concentration. |
| Raxar (grepfloxacin) 1997-1999 Fluoroquinolone | Treats respiratory tract infections, some gonorrhea, and non-gonococcal urethritis and cervicitis due to C. trachomatis | Gm+ and anaerobic activity greater than other floroquinolones; no adjustment needed in pts with renal dysfunction. | fatal heart arrhythmias (including torsades de pointes) |
| Rezulin (troglitazone) 1997-2000 Thiazolidinedione | Treats Type 2 diabetes | one of the first thiazolidinediones; targets insulin resistance; decreases both fasting and postprandial glucose levels; also reduces bp in obese pts. | severe liver toxicity; fulminant hepatotoxicity; death |
| Propulsid (cisapride) 1993-2000 GI prokinetic agent | Treats gastroesophageal reflux disease | no CNS-depressant and antidopaminergic effects (occur with metoclopramide); produces higher healing rates of esophagitis than either cimetidine or ranitidine | fatal heart arrhythmias; also many contraindications |
| Phenylpropanolamine 1939-2000 Sympathomimetic | Treats nasal congestion | non-prescription; less CNS stimulation than pseudoephedrine | greater risk for cardiovascular side effects and stroke than pseudoephedrine. |
| Lotronex (alosetron) 2000-2000 Selective 5-HT3 receptor antagonist | Treats women with diarrhea-predominant IBS | alternative therapy for women with IBS and have failed conventional therapy | many cases of severe side effects including ischemic colitis requiring hospitalization and/or surgery; death |
| Raplon (rapacuronium bromide) 1999-2001 neuromuscular blocker | For use as an adjuct to general anesthesia, for endotracheal intubation, and short surgical procedures | alternative to succinylcholine and has a longer duration of action | bronchospasm |
| Baycol (cerivastatin) 1997-2001 HMG-CoA reductase inhibitor | Treats primary hypercholesterolemia and mixed dyslipidemia | highly potent; lowers LDL cholesterol (up to 42% at 0.8mg daily dose) and triglycerides | rhabdomyolysis more frequent than other statins, especially when used at high dose or with gemfibrozil |
| Vioxx (rolfecoxib) 1999-2004 Selective COX-2 inhibitor | For anti-inflammatory, analgesic, and antipyretic | risk of GI toxicity significantly less than naproxen | myocardial infarction and stroke |
| Bextra (valdecoxib) 2001-2005 Selective COX-2 inhibitor | For anti-inflammatory, analgesic, and antipyretic | less GI side effects than naproxen | serious skin reactions |
| Tequin (gatifloxacin) 1999-2006 fluoroquinolone | Treats a variety of infections (Gm+ and Gm-) | much improved activity against penicillin-susceptible and -resistant pneumococci; lower incidence of photosensitivity than most quinolones | serious cases of hypo- and hyperglycemia |
| Zelnorm (tegaserod) 2002-2007 Selective 5HT-4 partial agonist | Treats chronic idiopathic constipation in pts of age <65 | One of few treatments for constipation-predominant IBS | MI, stroke, angina |
| Permax (pergolide) 1988-2007 ergot alkaloid derivative | For managing Parkinson's disease | exhibits 10 to 1000 times greater potency than bromocriptine and may be effective in pts tolerant to bromocriptine | Valvular regurgitation (valvular heart disease) |
| Trasylol (aprotinin) 1993-2007 Hemostatic | For use during CABG when pts are likely to sustain excessive bleeding | reduced need for blood transfusions; allows for a clearer field of view during surgery | renal failure, MI, heart failure, stroke, encephalopathy, and death |
| Neupro (rotigotine) 2007-2008 Non-ergoline dopamine agonist | For treatment of Parkinson's disease | first drug available in transdermal patch | decreased efficacy caused by formation of rotigotine crystals in the patch |
| Serentil (mesoridazine) 1970-2008 Phenothiazine antipsychotic agent | Management of psychotic disorders | alternate therapy for schizophrenic patients | cardiovascular effects (torsades de pointes) and sudden death |
Notes
Some of these drugs have been put back on the market in one form or another.
SourcesClinical Pharmacology [database on the Internet]. Gold Standard. 2008 – [cited 15 August 2008]. Available from http://www.clinicalpharmacology-ip.com/default.aspx
Kernan WN, Viscoli CM, Brass LM, et al. Phenylpropanolamine and the Risk of Hemorrhagic Stroke. N Engl J Med 2000;343:1826-32. Maggs DG, Buchanan TA, Burant CF et al. Metabolic effects of troglitazone monotherapy in type 2 diabetes mellitus. Ann Intern Med 1998;128:176-85.
Mangano DT, Tudor JC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006;354:353-65. Nolan JJ, Ludvik B, Beerdsen P et al. Improvement in glucose tolerance and insulin resistance in obese subjects treated with troglitazone. N Engl J Med 1994;331:1188-93.
Rueeg PC, Dunger Baldauf C, Dingemanse SA, et al. Tegaserod, a 5HT4 receptor partial agonist, devoid of significant electrocardiographic effects (abstract no. 3257). Gastroenterology 2001;120 (Suppl 1):A643.
Simons FER, Kesselman MS, Giddins NG et al. Astemizole-induced torsade de pointes. Lancet 1988 Sept 10; 2(8611):624. Wysowski, DK, Bacsanyi J. Cisapride and fatal arrhythmia. N Engl J Med 1996;335:290-1.
Zanettini R, Antonini A, Gatto G, et.al. Valvular heart disease and the use of dopamine agonists for parkinson's disease. N Engl J Med 2007;356:39-46.
