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Deaths Blamed On Medications Have Tripled Since '98

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Los Angeles Times

Published: September 11, 2007

The number of serious adverse events and deaths attributed to prescription medications has nearly tripled since the Food and Drug Administration initiated a system in 1998 to make it easier to report significant side effects, researchers said Monday.

Twenty percent of drugs accounted for 87.1 percent of adverse effects, and the biggest offenders were painkillers and drugs that modify the immune system to treat arthritis, according to the report in the Archives of Internal Medicine.

One-quarter of the increase could be attributed to a boost in prescriptions and another 15 percent to the introduction of new biotechnology drugs since 1998, but the rest of the increase could not be explained, said drug safety expert Thomas J. Moore of the Institute for Safe Medication Practices in Huntingdon Valley, Pa.

The FDA and a trade group representing drug makers agreed that the number of reported adverse events had been increasing, but they attributed much of the rise to an increase in voluntary reporting of the events. Studies have estimated that from as few as 3 percent of adverse events to a maximum of about 33 percent have been reported to the FDA.

'There are clearly other factors responsible for this increase, such as the increase in public attention to drug safety and use of the Internet to make it easier for the public to ... report adverse events to the FDA,' said Gerald Dal Pan, director of the FDA's office of surveillance and epidemiology.

Moore and his colleagues analyzed all of the serious adverse-event drug reports submitted to the FDA through its Adverse Event Reporting System, commonly known as MedWatch reports. Physicians and the public submit reports to the FDA or to drug makers, which are then required to forward them to the FDA.

Adverse events are those defined as resulting in death, a birth defect, disability, hospitalization or requiring intervention to prevent harm.

The number of such events grew from 34,966 in 1998 to 89,842 in 2005. During the same period, the number of deaths rose from 5,519 to 15,105.

From 1998 to 2005, the number of prescriptions written each year grew 25 percent.

Women were involved in 55.5 percent of the events. A disproportionate share occurred among the elderly - a full third of events in a group that accounts for 12.6 percent of the population. Fewer events than expected occurred among children younger than 18 - 7.4 percent in a group that represents 25 percent of the population.

Five of the top six drugs causing deaths were painkillers: oxycodone, fentanyl, morphine, acetaminophen and methadone. The sixth was the anti-psychotic drug clozapine.

Among the drugs causing the most nonfatal adverse events were estrogens, insulin, interferon beta, paroxetine, clozapine, oxycodone, warfarin and fentanyl. Paroxetine is an antidepressant. Interferon beta is used to treat multiple sclerosis and cancer, and warfarin is an anti-clotting agent.

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