FDA Panel Recommends Antipsychotic Drug Approvals for Children

An FDA advisory panel recommended this week that Seroquel, Zyprexa and Geodon should be approved for use among adolescents, despite concerns that side effects of the antipsychotic drugs may expose children to life-long health disorders.

The panel of outside experts voted to recommend that the FDA allow the manufacturers to market the medications to children, even though consumer groups, FDA staffers and some panel members expressed concerns over a lack of research into the long-term effects of the drugs, which have been linked to weight gain, increasing blood sugar and diabetes.

Eli Lilly and Co.’s Zyprexa, AstraZeneca’s Seroquel, and Pfizer’s Geodon are already approved for adult use for the treatment of schizophrenia and bipolar disorder, and many doctors already prescribe them off-label for children.

Although doctors are free to prescribed approved medications for non-approved uses, the drug makers are not permitted to specifically market the drugs for use among children and teenagers until after the FDA has determined that they are to be safe and effective for adolescents.

The FDA is not required to follow the recommendations of their advisory panels, but they usually do. Currently, only Johnson & Johnson’s Risperdal and Bristol-Myers’ Abilify have approval as antipsychotic drugs for children.

Atypical antipsychotic medications became the top-selling class of drugs last year, raking in $14.6 billion in sales, according to IMS Health Inc.

Zyprexa, Geodon and Seroquel side effects can include weight gain, high blood sugar, and increased risk of diabetes. Critics of the plan to market the drugs toward children say that the drugs treat disorders that are likely to require treatment for life, so long-term studies need to be conducted to see if the known health risks are increased over time, or if new health risks arise.

A report released by FDA researchers in advance of the panel’s hearing noted particular concern about the length of time youths would be on the medications.

“These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of the possible effects on growth and development,” the report said.

Some panel members echoed these concerns at the hearing held Tuesday. Half of the panel abstained from the Geodon vote, which passed 8-1, citing concerns that data from the company was incomplete.

Potential problems with antipsychotics have already lead to thousands of lawsuits against AstraZeneca and Eli Liilly over side effects of Seroquel and Zyprexa respectively.

Eli Lilly has paid more than $2.5 billion settling Zyprexa lawsuits filed by individuals and the government, including charges that they engaged in illegal marketing practices that encouraged off-label use.

AstraZeneca currently faces more than 9,000 Seroquel lawsuits from consumers who allege that they developed diabetes, pancreatits, a rare movement disorder known as tardive dykinesia, as well as other injuries.