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By Herb Newborg

Serious, Disabling and Fatal Adverse Drug Events Up Over 8%
Avandia and Seroquel lead the list of drugs harming people when used as directed.

In the third quarter of 2009, the number of serious, disabling and fatal adverse drug events reported to the FDA numbered 29,065, compared to 26,809 in the same quarter a year earlier, an 8.4 percent rise, according to the Institute for Safe Medicine Practices. For the first three quarters of 2009 combined, the total number of reports was 8.1 percent higher than in the same period of 2008.

ISMP’s QuarterWatch report reveals:

More than 1,000 reports of patient deaths were received for GlaxoSmithKline’s Avandia in the first three quarters of 2009, more than any other drug the non-profit monitors. Most deaths were attributed to cardiovascular causes and ISMP says that Glaxo responded by saying “most reports were generated by lawsuits.”

In the third quarter of 2009, AstraZeneca’s Seroquel antipsychotic, was the suspect drug in more possible cases of diabetes than all other drugs combined. The drugmaker also explained this by saying the cases were related to lawsuits.

ISMP also “observed a signal” for adverse events associated with the AndroGel and Testim sex hormone products, which are applied to the skin as a gel. Although approved only for use in men, ISMP observed 155 cases of reported injury in women and 22 events in children in the first three quarters of 2009, suggesting accidental exposure and inappropriate off-label use continues to cause injuries.

Two Zicam brand over-the-counter cold remedies were being blamed for people losing their sense of smell or taste, many permanently. In June 2009 the FDA demanded the immediate withdrawal of two Zicam brand cold remedies, Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs. The products are manufactured by Matrixx Initiatives of Scottsdale, Arizona. Both contained zinc, which a new study has shown can be toxic to smell receptors in the nose.

In seeking the withdrawal of the two Zicam products, the FDA cited 130 adverse event reports received over a period of several years. But in the two weeks after the FDA announcement, the agency received 511 additional reports; in the next quarter another 303 cases. In addition, the company had also received more than 1,000 complaints directly from consumers who said they lost their sense of smell. But the company had not reported any of these cases to the FDA.