WASHINGTON, April 30 (UPI) -- One out of every five prescription drugs with dangerous side effects arrives on the market without warnings, according to a study set to appear in Wednesday's issue of the Journal of the American Medical Association.
Of drugs with life-threatening side effects, doctors receive warnings in only half the cases even seven years later, the study reports.
The study recommends doctors should avoid prescribing new drugs for years when older alternatives are available to prevent inadvertently hurting patients.
"I would prescribe a new drug only when absolutely necessary, and then watch for adverse effects very, very closely," said Karen Lasser, one of the study's authors and researcher at Cambridge Hospital and Harvard Medical School in Cambridge, Mass.
Adverse drug reactions are blamed for 100,000 deaths in the United States every year and 1.5 million hospitalizations, according to the consumer advocacy group Public Citizen.
The study shows 16 dangerous drugs have been pulled off the market over the past 25 years -- five of them between Sept. 1997 and Sept. 1998. The authors said some 20 million Americans took one of those five drugs before they were recalled.
Sidney Wolfe, director of Public Citizen's Health Research Group and another co-author, blamed the Food and Drug Administration for failing to keep dangerous drugs off the market. Public Citizen has long been critical of FDA's system for tracking dangerous drugs once they are on the market. Although doctors are supposed to detect side effects and report to drug companies and FDA, the system operates only on a voluntary basis.
Wolfe said new warnings for dangerous drugs usually originate from bad publicity or public pressure as opposed to good work by FDA or drug companies.
"It has more to do with how much pressure can be exerted," Wolfe said.
The authors looked at FDA-approved drug warnings issued over the past 25 years appearing in the doctors' guide for drug reactions, the Physicians Desk Reference. They examined the length of time between when a drug is approved by FDA and when a serious warning for a drug, called a "black box," is added to the PDR.
The authors also examined the list of drugs FDA has recalled because of health concerns.
FDA officials said doctors want more drugs approved to provide more options for treating patients. Patients respond differently to different drugs and options are needed in case one drug turns out to be more dangerous than alternatives.
"Having options ... is beneficial if another (drug) runs into a safety issue," FDA's Robert T. Temple said.
Temple said FDA does approve some dangerous drugs for use -- such as cancer drugs -- because the benefits outweigh the risks.
A new poll by the Competitive Enterprise Institute, a free enterprise non-profit group, shows that 61 percent of cancer specialists believe FDA is too slow in approving cancer drugs. Sen. Bill Frist, R-Tenn., who also is a heart surgeon, said FDA has improved its approval time for those drugs, but that "more needs to be done to further improve the drug review process."
