AstraZeneca Drug Raises Diabetes Risk, Witness Says
AstraZeneca Plc’s antipsychotic drug Seroquel may double the risk of diabetes in some patients, a psychiatrist said ahead of the first two trials over the drug’s alleged risks.
Mentally ill patients who are already at increased risk for diabetes should be monitored because Seroquel can trigger the disease, Dr. Jack Abramson testified today. The testimony came in a pre-trial hearing in federal court in Orlando, Florida.
“The literature supports a doubling of the risk from the general population,” said Abramson, a Fort Lauderdale, Florida- based psychiatrist testifying for a former Seroquel user who is suing the drugmaker.
AstraZeneca, the U.K.’s second-largest drugmaker, faces about 9,000 lawsuits in the U.S. over claims Seroquel causes diabetes and other health problems. Seroquel, which generated sales of $4.03 billion in 2007, is the London-based company’s second-biggest seller after the ulcer treatment Nexium. The first trial is set to begin Feb. 2 in Orlando.
Abramson testified on behalf of David Haller, a 47-year-old from Largo, Florida. Haller, who suffers from bipolar disorder and has a history of sex crimes, began taking Seroquel in October 2002. He blames his August 2004 diabetes diagnosis on the drug, claiming AstraZeneca failed to warn about its risks, which far outweigh its benefits.
‘Risk Factors’
Haller was overweight before taking Seroquel but ballooned to about 230 pounds from 180 pounds after taking the drug, Abramson said.
“Mr. Haller possessed certain risk factors before the introduction of Seroquel, among them the high weight, yet he did not develop diabetes,” Abramson said. “The administration of the Seroquel unleashed or was a significant contributing factor that almost certainly broke the camel’s back.”
Among Haller’s other risk factors was his sedentary lifestyle, problems with hypertension and his history of taking other medications such as Depakote and Lithium, which are associated with weight gain.
Under cross-examination by AstraZeneca attorney Mike Brock, Abramson conceded that he couldn’t say that Seroquel was the sole cause of Haller’s disease.
“I cannot say with certainty that at no point in his life he would not have developed diabetes,” Abramson said.
Warnings to Doctors
Studies linking Seroquel, Eli Lilly & Co.’s Zyprexa and similar drugs to weight gain and diabetes prompted the U.S. Food and Drug Administration to require warnings to doctors in 2003 and 2004. AstraZeneca changed its label in January 2004, adding diabetes to the warning section.
Type II diabetes, the kind alleged in these lawsuits, is characterized by abnormally high blood sugar resulting from insufficient levels of insulin, AstraZeneca said in a court filing. The disease typically develops over a period of 10 to 12 years, the filing said. An internal analysis presented during a hearing in December showed that 2.4 percent of people who began Seroquel treatment with normal levels of sugar in the blood became technically diabetic after 52 weeks.
AstraZeneca attorney Steven Weisburd argued yesterday that the FDA specifically crafted Seroquel’s labeling to reflect a balanced approach on the potential risks of diabetes. The agency has acknowledged that the relationship between the drug and the disease isn’t completely understood, Weisburd said.
The drugmaker’s lawyers are asking U.S. District Judge Anne Conway to bar the testimony of Abramson and other expert witnesses for former Seroquel users because their opinions on the medicine “don’t meet the standards necessary to be admitted into evidence,” AstraZeneca spokesman Tony Jewell said in a phone interview.
