dangerous prescription
homethe fdainterviewsdiscussion
a dirty dozen

Since 1997, there has been a surge in the number of drugs withdrawn from the market for safety reasons, prompting many critics to question whether the FDA's accelerated approval process, funded in part by fees paid to the FDA by the manufacturers, has resulted in unsafe drugs being sold to consumers.

Here is a list of 12 prescription drugs that were withdrawn from 1997 to 2001, along with brief descriptions. (See below for additional information.)

+ Click on the drug names in the next column for more information.

Drug/chemical name (manufacturer)

Approved

Prescribed for

Adverse events

Withdrawn

Pondimin/fenfluramine (Wyeth-Ayerst)

1973

weight loss, obesity

pulmonary hypertension, heart valve disease

sep.97

Redux/dexfenfluramine (Wyeth-Ayerst)

apr.96

weight loss, obesity

pulmonary hypertension, heart valve disease

sep.97

Seldane/terfenadine (Hoescht Marion Roussel)

1985

seasonal allergies

heart problems when taken with other drugs

dec.97

Posicor/mibefradil (Roche Laboratories)

june.97

hypertension and angina

reduced activity of liver enzymes lead to harmful drug build-up, interactions too numerous for risk management

june.98

Duract/bromfenac (Wyeth-Ayerst)

july.97

pain relief

hepatitis, liver failure after treatment exceeded 10 days

june.98

Hismanal/astemizole (Janssen Pharmaceutica)

1988

seasonal allergies

heart arrhythmia caused by interaction with other drugs

june.99

Raxar/grepafloxacin (Glaxo Wellcome)

nov.97

antibiotic (pneumonia, bronchitis, some STDs)

Severe cardovascular problems (torsade de pointes, a ventricular arrhythmia)

oct.99

Rezulin/troglitazone (Parke-Davis/Warner-Lambert)

jan.97

Type 2 diabetes mellitus

liver toxicity

march.00

Propulsid/cisapride (Janssen Pharmaceutica)

july.93

night time heartburn

cardiac arrhrythmia

july.00

Lotronex/alosetron (Glaxo Wellcome)

feb.00

irritable bowel syndrome

ischemic colitis, constipation

nov.00

Raplon/rapacuronium bromide (Organon Inc)

aug.99

airway muscle relaxment during surgery

bronchospasm

march.01

Baycol/cerivastatin (Bayer)

sep.97

high cholesterol

rhabdomyolysis (muscle deterioration), possible renal and other organ failure

aug.01

+ Editor's Note
Association of a particular drug with injury or death may be sufficient for the FDA to require a drug to be withdrawn from the market, or for a drug company to decide to withdraw it voluntarily, but that determination is not the same as proving causation of injury or death, which would be necessary for plaintiffs to recover damages in court.

Determining the exact number of injuries or deaths associated with a drug is a difficult task, due in part to the fact that the reporting of adverse events is voluntary. The FDA must also take into account the possibilty of duplicate reports (filed by both the patient and the doctor, for example) or insufficient data. For these reasons, the FDA does not track these statistics specifically, but it will supply database-generated reports to interested parties who file a Freedom of Information Act request. Or, the public can view the database itself: researchers for The Los Angeles Times spent months combing through the FDA's AERS (Adverse Event Reporting System) database to gain an accurate count of deaths associated with use of the drugs covered in its Pulitzer Prize-winning December 2000 report, "How a New Policy Led to Seven Deadly Drugs."

 

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posted november 13, 2003

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