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FDA Considers Zyprexa Warnings For Kids

Nov 18, 2008 | Parker Waichman LLP

Pharmalot is reporting that the U.S. Food and Drug Administration (FDA) has said that labeling for Eli Lilly’s antipsychotic drug Zyprexa should include information about some of the drug’s more recently publicized risks and adverse effects such as weight gain, in children, hyperglycemia, and other metabolic effects.

The FDA statement was included in briefing documents that were developed for a Pediatric Advisory Committee taking place today, said Pharmalot.  That meeting is taking place in order to comply with the Best Pharmaceuticals for Children Act of 2002, says Pharmalot, which added that the act looks at all drugs “recently tested in children.”  While Zyprexa—a potent brain tranquilizer that calms hallucinations related to schizophrenia and bipolar mania—is only approved for the treatment of schizophrenia and bipolar disorder, it was marketed for use in milder cases of bi-polar disorder and for dementia.  Also, internal Lilly documents and e-mail messages confirm Lilly marketed Zyprexa off-label.  It was later found that Zyprexa can cause severe weight gain and an increase in blood sugar in many patients.  According to the American Diabetes Association, Zyprexa is likelier to cause diabetes than most other medicines for schizophrenia and bipolar disorder.

Pharmalot quoted FDA reviewers (page 12 of the briefing documents) as saying that, “No new safety signals emerged as part of this review; however, it has made us aware that the pediatric population is not spared from the adverse events caused by (Zyprexa).  The potential risks … should be weighed against the potential benefit when choosing to initiate therapy.”  Pharmalot noted that Zyprexa is approved for people 18 years of age and older; however, more and more, it seems that prescriptions are being written for children under the age of 18 and Lilly is working to obtain FDA approval to specifically  market Zyprexa to those aged 13 to 17.

Earlier last month we reported that Lilly, in its ongoing Zyprexa scandal, agreed to pay $62 million to 32 states and Washington, D.C. to settle claims it improperly marketed Zyprexa.  Late last month we reported that Lilly posted a third-quarter net loss of $465.6 million amid charges related to government investigations into its marketing of Zyprexa.  Earlier this month, the Associated Press (AP) reported that Minnesota joined the many states looking for compensation from Lilly over issues with Zyprexa.  And, now, not just states are involved, insurers, pension funds, and unions have been among those groups legally seeking compensation from Lilly and accusing it of concealing some of Zyprexa's adverse effects and for its marketing of the drug for off-label uses.  The 33-state settlement—the largest settlement paid by a drug company in a state consumer case—ended an 18-month investigation led by the offices of the attorneys general of Illinois and Oregon who claim that Lilly violated consumer protection laws by urging doctors to prescribe Zyprexa to patients who did not need the medication

CNN reported in an earlier release that, since 2005, Lilly has paid out over $1 billion in liability claims connected to Zyprexa.  CNN also pointed out that Lilly faces more problems, including a civil and criminal investigation led by federal prosecutors in Philadelphia.


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