Avandia, Seroquel Top List of Most Common Adverse Event Reports

According to a new analysis of serious, disabling and fatal adverse events reported to FDA during the third quarter of 2009, the controversial diabetes drug Avandia was associated with the most reports, followed by the antipsychotic drug Seroquel.

The analysis, which was released Thursday by the Institute for Safe Medicine Practices (PDF), found that a total of 29,865 adverse event reports were received by the FDA during the quarter. This was an 8.4% increase over the number of reports filed during the third quarter of 2008.

There were a more than 1,200 reports received during the quarter involving severe or fatal side effects of Avandia, most of which involved cardiovascular problems. Coming in second, Seroquel side effects generated 977 adverse event reports. The only other drugs that received more than 500 reports during the third quarter were Lioresal and Fentanyl, with 796 and 688 reports respectively.

Both GlaxoSmithKline and AstraZeneca claim that the high number of reports connected with their drugs were caused by thousands of Avandia lawsuits and Seroquel lawsuits being pursued by former users who allege that the pharmaceutical companies failed to adequately warn about health risks associated with the drugs.

Avandia (rosiglitazone) is a thiazolidinedione agent, a class of drugs approved by FDA in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years over concerns about the risk of Avandia heart problems.

This week, the Senate Finance Committee issued a blistering report, accusing GlaxoSmithKline of hiding information on Avandia heart attack risk and intimidating scientists and doctors. The FDA has announced it is continuing to conduct an Avandia safety review amid calls from many for the federal agency to issue an Avandia recall.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism.

AstraZeneca faces about 26,000 lawsuits that allege the drug causes weight gain and diabetes, which plaintiffs maintain that the company knew but did not reveal to doctors and patients. The first Seroquel trial began last week.

Even though it did not appear on the list, the Institute made special mention in its executive summary about reports of injuries associated with over-the-counter nasal sprays and gels sold under the Zicam label. A Zicam recall was issued last summer after the FDA warned that the zinc-based sprays and gels were causing anosmia, a loss of the sense of smell. Although the FDA had received only 130 complaints, an investigation of the manufacturer, Matrixx Initiatives, Inc., turned up more than hundreds of unreported anosmia complaints from customers that the company failed to turn over to FDA as required by federal regulations.

The institute says more action is needed from FDA to find out the true scope of the Zicam problem.

“Further study is required to determine how many people permanently lost their sense of smell as a result of these withdrawn products,” the report states. “We recommend that the FDA Commissioner’s office conduct an independent review of the Zicam products episode for its implications for regulatory law, enforcement policy, and the possibility that other dangerous compounds may still be in widespread use.”

Zicam was sold as a homeopathic product, and did not undergo FDA premarket safety reviews. However, the company must submit any future products to FDA for review before it can release them to consumers.

Matrixx Initiatives also faces a number of Zicam lawsuits by people who claim to have lost their sense of smell after using the nasal sprays and gels.