Zyprexa Faces New FDA Scrutiny

On November 14, 2008, U.S. regulators announced that Eli Lilly & Co.’s antipsychotic Zyprexa should be watched for potential risks in children. The FDA recommended adding a new warning to Zyprexa about the risk of weight gain and other metabolic changes in children, side effects already noted for adults, according to safety reviews posted on the agency’s Web site.

The review is required under the Best Pharmaceuticals for Children Act of 2002 for all drugs recently tested in children. Outside experts on the FDA’s Pediatric Advisory Committee will discuss the report and make recommendations at a November 18, 2008 meeting. Zyprexa, known chemically as olanzapine, is Lilly’s biggest drug with $4.76 billion in sales last year.

“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 olanzapine therapy,” the FDA staff wrote. ” The potential risks of olanzapine therapy should be weighed against the potential benefit when choosing to initiate therapy.”

The FDA is weighing whether to approve Zyprexa for patients 13 to 17 years old, said Lilly spokeswoman Marni Lemons in a telephone interview. The drug is currently approved for those 18 and older. Data from clinical trials on weight gain in younger patients is contained in the prescribing information.

Court documents recently obtained by Bloomberg News in July illustrusted that Lilly trained its sales staff to downplay risks for Zyprexa and encourage doctors to prescribe the drug beyond its approved uses. Some patients gained as much as 80 pounds and had blood sugar 3.5 times higher than patients on a dummy pill, according to documents filed in a lawsuit brought by the state of Alaska.

The company took a $1.48 billion charge in the third quarter to settle U.S. and state investigations into its Zyprexa marketing.