There are 181 popular prescription drugs on a “Do Not Use” list issued by the watchdog group Public Citizen (search) on Wednesday.
The drugs, including the cholesterol-lowering drug Crestor (search), the birth control pill Yasmin (search), and controversial pain relievers Celebrex (search) and Bextra (search), 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 (search) on Vioxx (search) 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.
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 (search), because of what Public Citizen says is an increased risk of the muscle disorder rhabdomyolysis (search). 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 percent 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.”
By Todd Zwillich, reviewed by Michael W. Smith, MD
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.