• Defective Drug Side Effects

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Prescription drug-related adverse events and deaths have increased nearly threefold since 1998 when the Food and Drug Administration implemented a system for reporting serious side effects, researchers said yesterday.

According to a new report in the Archives of Internal Medicine , a relatively small portion of drugs, mostly painkillers and arthritis medications that alter the immune system, caused the majority of adverse events. However, an increase in prescriptions and the introduction of new biotechnology drugs are also partly to blame, the report said.

“The clear finding is that we are losing ground in terms of drug safety, and that ought to be of great concern,” said Thomas Moore, leader of the study and drug-safety expert at the Institute for Safe Medication Practices.

Who's to Blame?

In the report, both the FDA and the current system of healthcare—including medical professionals and caregivers—are cited for their inability to properly manage medications. Still, Moore said that there's “plenty of blame to go around.”

“This is a direct set of data that shows the system is failing and it is getting worse,” he added.

Safety Monitoring of Prescription Drugs

The FDA acknowledged the rise in adverse event reports, but pointed to an increase in reporting itself as a major cause.

In recent times, the FDA has been highly criticized for its monitoring of prescription drugs prior to and after approval.

Serious adverse events are defined as those that result in hospitalization, death, birth defects, disability or other serious injury. Individuals and physicians can submit reports regarding these types of events to the FDA's MedWatch reporting program or to drug companies, which must forward reports to the FDA.

(Source: The Seattle Times online)

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