fda track record (partial) of failure

FDA TRACK RECORD (PARTIAL) OF FAILURE

DECEMBER 6, 2004. Drawn from a PBS Frontline report on dangerous medical drugs (2003), here is a list of 12 drugs that were taken off the market (withdrawn) between 1997 and 2001.

In each case, of course, the drug had been initially approved as both safe and effective by the FDA and released for public use.

In each case, the drug was later withdrawn because it was unsafe.

As you read and note the names of these drugs, recall the glowing TV ads you saw pumping up their benefits.

As with recently withdrawn Vioxx, note that heart problems feature large in the adverse effects column. We can correctly assume that MANY people who experienced these heart problems were THEN treated with MORE drugs by their doctors, who mistakenly assumed the patients were suffering from "natural" heart disease.

Pondimin/fenfluramine (Wyeth-Ayerst) approved:1973 for weight loss, obesity; adverse effects:pulmonary hypertension, heart valve disease; withdrawn:sep.97

Redux/dexfenfluramine (Wyeth-Ayerst) approved:apr.96 for weight loss, obesity; adverse effects:pulmonary hypertension, heart valve disease; withdrawn: sep.97

Seldane/terfenadine (Hoescht Marion Roussel) approved:1985 for seasonal allergies; adverse effects:heart problems when taken with other drugs; withdrawn:dec.97

Posicor/mibefradil (Roche Laboratories) approved:june 97 for hypertension and angina; adverse effects:reduced activity of liver enzymes lead to harmful drug build-up, interactions too numerous for risk management; withdrawn:june 98

Duract/bromfenac (Wyeth-Ayerst) approved july 97 for pain relief; adverse effects: hepatitis, liver failure after treatment exceeded 10 days; withdrawn june 98

Hismanal/astemizole (Janssen Pharmaceutica) approved 1988 for seasonal allergies; adverse effects:heart arrhythmia caused by interaction with other drugs; withdrawn:june 99

Raxar/grepafloxacin (Glaxo Wellcome) approved:nov.97 as Antibiotic to treat pneumonia, bronchitis, some STDs; adverse effects:severe cardovascular problems (torsade de pointes, a ventricular arrhythmia); withdrawn: oct.99

Rezulin/troglitazone (Parke-Davis/Warner-Lambert) approved:jan.97 for Type 2 diabetes mellitus; adverse effects:liver toxicity; withdrawn:march 00

Propulsid/cisapride (Janssen Pharmaceutica) approved:july 93 for night time heartburn; adverse effects:cardiac arrhrythmia; withdrawn: july 00

Lotronex/alosetron (Glaxo Wellcome) approved: feb.00 for irritable bowel syndrome; adverse effects: ischemic colitis, constipation; withdrawn: nov.00

Raplon/rapacuronium bromide (Organon Inc) approved:aug.99 for airway muscle relaxment during surgery; adverse effects:bronchospasm; withdrawn:march 01

Baycol/cerivastatin (Bayer) approved:sep.97 for high cholesterol; adverse effects: rhabdomyolysis (muscle deterioration), possible renal and other organ failure; withdrawn:aug.01

JON RAPPOPORT www.nomorefakenews.com
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