Zypreza, Seroquel Side Effects in Children Need Further Review: FDA Staff

According to documents released Friday, FDA staff members say that the agency needs to conduct more of an in-depth investigation into the metabolic side effects for children using Seroquel, Zyprexa and other newer atypical antipsychotics, which could lead to weight gain, diabetes and other serious health problems.

Reviewers from the FDA’s pharmacovigilance division warned the agency that there needs to be more study into Eli Lilly’s Zyprexa and AstraZeneca’s Seroquel side effects on children. However, on the same day, AstraZeneca announced that the FDA approved the use of Seroquel in children ages 13 to 17.

The Division of Pharmacovigilance (DPV) report was originally written in October, however it was only released last week. The division was asked to do a safety review of a number of antipsychotics and how they affect teenagers in November 2008 by an FDA advisory committee. FDA staff looked at a number of drugs, including Seroquel and Zyprexa, as well as Johnson & Johnson’s Risperdal, Pfizer’s Geodon and Bristol-Meyers Squibb’s Abilify.

The report warns that the adverse events reporting system relied on by the FDA to alert the agency for potential problems manifesting in approved products is not exacting enough to accurately detect and quantify potential problems with the antipsychotics. Reviewers pointed to a study released in October in the <Journal of the American Medical Association that found that children on Zyprexa and Seroquel showed signs of rapid and dramatic weight gain and said that more studies need to be conducted into the metabolic effects of those and similar drugs.

Seroquel (quetiapine fumarate) is one of the more widely used atypical-antipsychotic, generating nearly $4.45 billion in annual sales for AstraZeneca. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism. Seroquel has been used by more than 19 million people worldwide. In addition to its approval for use in teens, the FDA also approved the use of Seroquel XR as an add-on treatment for major depressive disorder.

AstraZeneca faces thousands of Seroquel lawsuits that allege the company failed to adequately warn about the risk of weight gain, which caused users to develop diabetes and other serious health conditions. Although internal documents produced during the Seroquel litigation suggest that the company was aware of the Seroquel diabetes problems, the drug maker continues to fight the cases and has spent over $600 million in defense costs before the first case has gone to trial. All federal Seroquel cases have been consolidated in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida.

Eli Lilly has also faced legal a number of legal claims over side effects of Zyprexa. The drug maker has already paid over $2.5 billion to settle individual and government Zyprexa lawsuits for failing to adequately disclose the risk of diabetes and weight gain. They have been accused of fraudulent marketing of the drug for uses that they had not established were safe or effective.