Zyprexa diabetes warning still needs to be updated

By Austin Kirk
Posted August 4, 2008

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Although Eli Lilly has already paid more than $1.2 billion to settle over 30,000 Zyprexa lawsuits filed by users who claimed that the drug maker failed to provide adequate warnings about the risk of weight gain and diabetes, the FDA still believes that the warning label may not be strong enough.

Individual users and various states have filed lawsuits against Eli Lilly alleging that the drug maker failed to disclose information about the risk of Zyprexa side effects. Evidence has established that Lilly trained its sales force to encourage sales of the drug for off-label uses and downplayed the risks of weigh gain, diabetes and high blood sugar.

In October 2007, Lilly updated the packaging to include warnings about weight gain, and an association with high blood-sugar levels, which is a risk factor for diabetes. However, according to Bloomberg, a letter sent to Lilly by the FDA indicates that the warning still needs to be changed to directly link Zyprexa to diabetes and high blood sugar.

Zyprexa is an atypical antipyschotic which is approved for treatment of bipolar disorder and schizophrenia. Other uses include treatment of anxiety, obsessive compulsive disorders and autism. Eli Lilly has settled thousands of Zyprexa lawsuits while continuing to deny liability or any wrong doing. However, the continued sale of Zyprexa without adequate warnings about the side effects could open the door to thousands more cases and liability exposure.

Seroquel, which is another drug in the same class of medications, has also been associated with an increased risk of diabetes and pancreatitis, and has also been the subject of a number of lawsuits claiming the drug’s maker, AstraZeneca, failed to adequately warn of the risks. The first Seroquel lawsuits are expected to go to trial toward the end of this year.