Watchdog Group: Avoid 181 Prescription Drugs

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Watchdog Group: Avoid 181 Prescription Drugs

Public Citizen Cites Poor Safety, Safer Alternatives

for Most

By Todd Zwillich

WebMD Medical News

Reviewed By , MD

on Wednesday, January 12, 2005

Jan. 12, 2005 - There are 181 popular prescription

drugs on a " Do Not Use " list issued by the watchdog

group Public Citizen on Wednesday.

The drugs, including the cholesterol-lowering drug

Crestor, the birth control pill Yasmin, and

controversial pain relievers Celebrex and Bextra, are

condemned by the group because their potentially

dangerous side effects far outweigh their benefits or

because there are safer alternatives that work just as

well, says Sidney Wolfe, MD, director of the Public

Citizen Health Research Group.

The group is a longtime critic of the U.S. drug

industry and a watchdog over the FDA. The agency has

largely failed to adequately police the safety of new

drugs coming on the market or to track potential

dangers once they are already on sale, Public Citizen

contends.

" This is a massive public health problem, " Wolfe says.

Wolfe says the list, contained in a larger volume of

consumer-oriented information on 536 drugs called

Worst Pills, Best Pills, is necessary because the FDA

has been slow to take action against potentially

dangerous medications.

" We asked FDA four years ago to put a black box

warning on Vioxx and Celebrex, but they didn't do it, "

says Wolfe, referring to two popular arthritis drugs

that have come under intense scrutiny because of

evidence that they increase the risk of heart attack.

Vioxx was pulled from the worldwide market by

manufacturer Merck & Co. in September, and last month

the National Institutes of Health halted a trial of

Pfizer's Celebrex because of similar concerns.

Risks associated with Celebrex have only been seen at

high doses of the medication - 400 mg a day. Heart

problems with Bextra have only been seen in patients

undergoing heart bypass surgery.

Nearly 100,000 Americans die each year because of

adverse drug reactions, Wolfe says. That number was

quoted in a 1998 University of Toronto study

estimating that 106,000 people died in U.S. hospitals

in 1994 because of drug reactions.

The list warns against using Crestor, a

cholesterol-lowering statin, because of what Public

Citizen says is an increased risk of the muscle

disorder rhabdomyolysis. Women should avoid using the

contraceptive pill Yasmin, it says, because it can

cause elevations in blood potassium while offering no

advantage over other birth control pills. If severe,

high potassium levels can cause heart rhythm problems.

Wolfe says the list was not intended to scare

consumers away from using prescription medications,

but to help them cut through what Public Citizen sees

as misleading drug industry ads directed at patients

and doctors.

" There are people, organizations, that think all

prescription drugs are terrible. We are not one of

them, " he says.

Jeff Trewhitt, a spokesman for the Pharmaceutical

Research and Manufacturers of America, the drug

industry's largest lobbying group, calls the book

" another source of information " for consumers and

doctors to use.

Trewhitt declined to comment on individual drugs but

says fewer than 3% of all pharmaceutical products

approved by the FDA have been pulled off the market

because of safety problems. He adds that patients

should not stop taking a drug without first checking

with their doctor.

" There may be some room for improvement " in the FDA's

regulation of drug safety, Trewhitt says. " But we

believe the FDA has struck exactly the right approach

to the risk-benefit interpretation. "

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SOURCES: Wolfe, S. Worst Pills, Best Pills: A

Consumer's Guide to Avoiding Drug-Induced Death or

Illness, Pocket Books, Jan. 4, 2005. Sidney Wolfe, MD,

director, Public Citizen's Health Research Group. Jeff

Trewhitt, spokesman, Pharmaceutical Research and

Manufacturers of America.