by Mario Lozano on January 5, 2007
in Zyprexa
Eli Lilly and Co. said on Thursday it has agreed to pay up to $500 million to settle 18,000 Zyprexa lawsuits alleging it had failed to adequately warn patients that Zyprexa may increase the risk of diabetes.
“While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians,” said Sidney Taurel, chairman of the board and chief executive officer of Eli Lilly and Company. “We wanted to reduce significant uncertainties involved in litigating such complex cases. Our decision to resolve the claims does not change the fact that Zyprexa has and will continue to improve the lives of millions of patients around the world who are suffering from schizophrenia and bipolar disorder. These settlement agreements will enable Lilly to focus first and foremost on addressing unmet medical needs through research, educational programs and partnerships with doctors and patients.”
In June 2005, Lilly agreed to pay about $700 million to settle 8,000 Zyprexa lawsuits in the United States.
The majority of the of the Zyprexa lawsuits claim that before September 2003, the package insert warning about the potential link between Zyprexa and hyperglycemia and diabetes was not adequately displayed.
In September 2003, the Food and Drug Administration required label changes for Zyprexa and all atypical antipsychotics, adding more information warning about a possible link with diabetes.
In 2004, a panel of the American Diabetes Association found that Zyprexa caused diabetes more than other widely used antipsychotic drugs, in part becuase it has a tendency to cause more higher weight gain. However, the FDA has never made a similar finding.
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by Mario Lozano on October 27, 2005
in Pargluva
Pargluva, a proposed diabetes drug from Bristol-Myers Squibb and Merck & Company, appears to increase the risk of death, heart attack or stroke, according to a study published in a leading medical journal last week.
The study was conducted by the two Cleveland Clinic cardiologists who warned in 2001 about the cardiovascular risks associated with Vioxx, which was pulled from the market last year. They used the data, from the company-funded clinical trials, that was submitted to the Food and Drug Administration.
Their analysis found 1.47 percent of the diabetic patients who took Pargluva during clinical trials died, suffered a heart attack or stroke-more than double the rate among those taking a placebo or an already approved rival drug sold as Actos.
James Brophy of McGill University in Montreal wrote an accompanying editorial for the study that was also published in The Journal of the American Medical Association, where he questions the “methodological decisions in the sponsor’s FDA application” that may foster an illusion of safety for Pargluva. He also included a list of 8 methods observed in the application that in his opinion may have contributed to an overestimate of the safety profile.
(via The Journal of the American Medical Association)