U.S. regulators received more than twice as many reports of deadly or debilitating side effects from drug treatment in 2005 as they did seven years before, a study found.

Fifty-one drugs accounted for almost half of the 467,809 cases reported during the eight years covered, researchers wrote in today’s Archives of Internal Medicine. Painkillers, such as Teva Pharmaceutical Industries Ltd.’s generic oxycodone, and drugs that alter the immune system, including Johnson & Johnson’s Remicade, were linked to a disproportionate number of deaths, which almost tripled in 2005 compared with 1998.

Safety experts criticize the voluntary system for reporting side effects, saying that many rare and unexpected consequences of prescription drug use are missed because doctors fail to link their patients’ conditions to their medication. U.S. lawmakers are considering legislation that would call on the Food and Drug Administration to use databases like those of insurance companies to more systematically detect harmful side effects.

“Substantially growing numbers of patients are experiencing serious injuries from drug therapy,” said the researchers, led by Thomas Moore from the Institute for Safe Medication Practices, a non-profit group in Huntingdon Valley, Pennsylvania. “The existing system is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislative, policy, and institutional changes.”

2005 Deaths

More than 15,000 people died from drug reactions in 2005, compared with 5,519 people in 1998, the researchers said. Most of the fatalities were linked to generic pain pills, including oxycodone, fentanyl, morphine and acetaminophen, which is sold without a prescription by Johnson & Johnson as Tylenol.

A total of 89,482 serious side effects from drug treatment were reported to the FDA in 2005, more than 2 1/2 times the 34,966 reported in 1998, the study found. The number of serious reactions increased four times faster than the total number of prescriptions written for patient use outside the hospital. About 1,500 drugs had reported side effects.

The voluntary reports by doctors and other health-care providers are made directly to the FDA or to the companies that make the medications. The manufacturers are required to forward any information they receive on the unintended consequences of their drugs including deaths, birth defects, disabilities and hospitalizations, to the FDA.

Christopher Kelly, a spokesman at the FDA, didn’t immediately return a phone call seeking comment today.

More Reporting

Reports to the agency tend to increase after news stories about side effects linked to specific drugs. As a result, some of the increase may represent more reporting of side effects, not an increase in the overall number of complications stemming from treatment, doctors said.

Estrogen, sold by Wyeth as Premarin and Prempro, was one of the medications with 500 or more reported serious adverse events in a single year. The hormones were the subject of 3,996 reports in 2004, two years after the Women’s Health Initiative found estrogen replacement therapy increased the risk of heart complications. A year before the report, there were 617 side- effect reports on estrogen.

“Although there is always room for improvement, the U.S. has the world’s best drug safety record,” said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. “As a result of the combined efforts of FDA and pharmaceutical research companies, only about 3 percent of prescription medicines have been withdrawn from the American market for safety reasons over the last 20 years.”


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