June 12, 2009
A U.S. Food and Drug Administration’s (FDA) advisory panel voted to recommend approval of three popular psychotropic medications—atypical antipsychotics— for children with specific conditions. The vote concerned AstraZeneca PLC’s Seroquel, Eli Lilly and Company’s Zyprexa, and Pfizer Inc.’s Geodon .
According to the agency’s advisory panel, the three drugs have been deemed safe and effective for pediatric patients—children and teens—who have been diagnosed with schizophrenia or bipolar disorder, Reuters reported. However while the panel did recommend approval of the broader use for Seroquel, Zyprexa, and Geodon, it did warn about the drugs’ long-term effects in children, said Reuters. All three drugs are approved for use in adults and, like any other medication, can be used off-label if the prescribing physician feels the medication is warranted, in this case, to children, Reuters pointed out. An expanded approval by the FDA would enable the industry to market the drugs for kids.
The final approval decision rests with the FDA itself. The agency usually follows recommendations of advisory panels, though it is not required to do so.
Seroquel, Zyprexa, and Geodon have long been prescribed off-label to the younger demographic for schizophrenia and bi-polar diagnoses and many of these younger patients have connections to child welfare and juvenile justice systems, said Youth Today last week. For example, approximately 14 percent of children in foster care are prescribed some psychotropic medication, reported Youth Today citing a 2006 policy paper written by the Institute for Juvenile Research at the University of Illinois at Chicago. This figure will likely increase as the practice of prescribing atypical antipsychotics to children becomes a more greatly accepted practice, now that approval to do so has been granted.
But, the drugs are not without problems. For instance, this January, a study published in The New England Journal of Medicine found that patients taking Seroquel and other atypical antipsychotics were likelier to suffer sudden cardiac death than patients taking older antipsychotics. This April, an FDA advisory panel cited the risk of Seroquel and sudden cardiac death when it recommended the drug not be approved as a first line treatment for depression. AstraZeneca faces over 9,000 Seroquel lawsuits filed by people who claim the company withheld information about the drug’s diabetes risk.
In addition to blood sugar risks, there are concerns Geodon might increase the risk of a specific, potentially fatal heart-rhythm irregularity. Additional side effects include: Feeling unusually tired; nausea; constipation; dizziness; restlessness; diarrhea; rash; cough; runny nose; and abnormal muscle movements, including tremor, shuffling, and uncontrollable movements.
Some panel members expressed concern, said Reuters, that short-term research did not adequately reveal the effects of these medications on children over time. “I’m concerned about the lack of true long-term studies” especially in younger patients “who will have a long lifetime, hopefully,” said Ruth Day, a researcher at Duke University, quoted Reuters. Some agency advisors were unclear why the FDA accepted the three medications in children for what would likely be a lifetime of treatment when studies only looked at this demographic for between three and six weeks, reported Reuters, noting that effect of these drugs on the developing brain remains unknown.
Also of concern was the likelihood of drug misuse and prescribing practices for other conditions—attention deficit disorder (ADD) or hyperactivity, to name two—Reuters pointed out, as well as treatment to much younger children. “Soon we’ll be seeing four-, five- and six-year-olds being treated. It’s a slippery slope … I just get worried about where this is going,” said Kenneth Towbin an agency panelist and head of the National Institute of Mental Health’s child psychiatry mood disorders program, quoted Reuters.