Antipsychotic Drugs’ Effects On Kids Need More Study, FDA Panel Says

We’ve been following the issue of prescribing psychotropic drugs to pediatric patients for some time, especially regarding efficacy and safety. In June we wrote that a U.S. Food and Drug Administration (FDA) vote was scheduled regarding three psychotropic medications and their safety and efficacy for children with specific conditions.

At that time, the Wall Street Journal reported that the agency said the medications—AstraZeneca PLC’s <"http://www.yourlawyer.com/topics/overview/Seroquel-And-Cardiac-Death">Seroquel, Eli Lilly and Company’s <"http://www.yourlawyer.com/topics/overview/zyprexa">Zyprexa, and Pfizer Inc.’s <"http://www.yourlawyer.com/topics/overview/geodon">Geodon—effectively treat some psychiatric disorders in pediatric patients, but come with serious risks, including sedation and weight gain.

Now, Reuters is reporting that drug reviewers are recommending regulators conduct additional studies into the effects of these drugs on children, citing a report released last week. According to FDA staff, said Reuters, an emerging health insurance claim study revealed that children treated with psychotropic medications “were much more likely to experience an adverse metabolic effect than adults, and the likelihood was directly correlated with age.” Such effects include “abnormal weight gain, diabetes, and increases in cholesterol and blood pressure,” said Reuters.

“Although observational studies have limitations … this provocative hypothesis should nonetheless be subject to some further evaluation by the agency,” staff in the FDA’s division of pharmacovigilance wrote in an October 14 memo, quoted Reuters. Previously, the FDA’s psychiatric product division director, Thomas Laughren, said results such as these “are of particular concern in pediatric patients because of the life-long nature of these disorders,” quoted the Wall Street Journal, which added that the issue with weight gain as a result of many antipsychotic medications is that extra weight can lead to diabetes and cardiovascular disease.

AstraZeneca announced last week that the FDA approved use of its atypical antipsychotic Seroquel for use in schizophrenic patients ages 13 to 17 and for children with bipolar disorder ages 10 to 17, said Reuters. Reuters also noted what we have long been saying, that while these atypical antipsychotics are approved to treat these diseases, they are also approved for depression and some other mental illnesses; however, the medications are seeing an upward trend prescribing to pediatric patients for unapproved uses that include attention deficit hyperactivity disorder (ADHD).

Physicians are free to prescribe approved medications at their discretion, whether the uses are approved or not. Drug makers are prohibited from marketing any drug for nonapproved uses.

Advisors external to the agency asked for additional and longer-term information on these drugs and their effects in pediatric patients last November, said Reuters. These findings will be discussed by the agency at a public meeting tomorrow.

Friday’s report indicated that agency review of the medications showed a rise in reporting of metabolic problems linked to Zyprexa and Seroquel, according to Reuters. A spokesman for Lilly said that greater risks do exist for pediatric patients treated with Zyprexa, said Reuters. Although not approved for children, applications for use of these medications are pending for adolescents.

The FDA review included Bristol-Myers Squibb Co and Otsuka Pharmaceutical Co’s Abilify, Johnson & Johnson’s Risperdal, and Pfizer Inc’s Geodon, as well, noted Reuters.

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