(mibefradil), and Duract (bromfenac) in 1997,
For instance, Posicor--a calcium channel blocker used to treat high blood pressure and chronic angina--was withdrawn after it was shown that certain drugs rose to dangerous levels when administered with Posicor
. In fact, at the time it was withdrawn, researchers had identified more than 25 drugs that had these interactions.
This is another instance in a long line of postmarketing disasters including Rezulin, Cardura, and Posicor
. Some of these adverse experiences may be attributed to interactions with other cardiovascular drugs.
The eight drugs lately withdrawn were GlaxoSmithKline's Lotronex, for irritable bowel syndrome; American Home Products' Redux, a diet aid; the Bayer Corporation's Raxar, an antibiotic; Pfizer's Trovan, also an antibiotic; Roche's Posicor
, a blood-pressure medication; Wyeth-Ayerst's Duract, a painkiller; Warner-Lambert's Rezulin, a diabetes drug; and, this spring, Organon's Raplon, an anesthetic.
Some drugs, such as Pondimin and Redux, had more adverse effects for women because they were prescribed mainly to women; others, such as Posicor
, were prescribed equally to both women and men, and still had more adverse effects for women.
These include a pain killer (Duract); diet pills (Phen Fen and Redux); and a blood pressure medication (Posicor
Wolfe: Raw milk, aspirin and Reye's Syndrome, tampons and toxic shock, Phenformin and lactic acidosis, Posicor
and Duract are all instances where there was clear, unequivocal data at the FDA showing harm, but where the FDA failed to either ban a product or require necessary labeling.
Drugs withdrawn between September 1997 and June of last year were Redux, Pondimin and Duract, all marketed by American Home Products Corp.; Seldane, from Hoechst AG; and Posicor
, marketed by Roche AG.
The withdrawals included the obesity drug Redux, the analgesic Duract, and the cardiac drug Posicor
, which were withdrawn from the market for safety reasons within a year of approval.
Commonly prescribed CCBs include diltiazem (Cardizem[R], Tiazac[R], Dilacor[R]), verapamil (Isoptin[R], Calan[R], Verelan[R], Covera HS[R]), mibefradil (Posicor
), amlodipine (Norvasc[R]), felopidine (Plendil[R]), isradipine (DynaCirc[R]), nicardipine (Cardene[R]), nisoldipine (Sular[R]), and nifedipine (Procardia[R]).
Manufacturers Roche Products Ltd voluntarily decided to stop selling Posicor
, which was launched last year and is marketed in 38 countries, including Britain.
for its alleged refusal to provide coverage for Viagra prescriptions; a class action suit filed in Federal court alleging that group health insurance plans have denied insurance coverage for Viagra users; a similar California suit against Aetna Life Insurance; a report on the 30 deaths possibly connected to the use of Viagra; a copy of a letter sent by Pfizer to doctors regarding the use of Viagra in combination with other drugs, including nitrates; and a warning by Roche Laboratories on the use of Viagra with its blood pressure drug Posicor