FDA panel weighs antipsychotic drug use in kids

Makers of three blockbuster antipsychotic drugs urged U.S. advisers on Tuesday to recommend approval of the medicines for children as young as 10 with schizophrenia or bipolar disorder. Eli Lilly and Co's Zyprexa, AstraZeneca's Seroquel and Pfizer's Geodon are sold for treating adults and already are given to youngsters. But winning Food and Drug Administration approval would allow the companies to promote them specifically for children and teens. Wider approval could boost sales that now top a combined $10 billion annually. FDA reviewers agreed the drugs seemed effective for younger patients but asked a panel of outside experts to consider risks of weight gain, sleepiness and other reactions. Consumer groups said too little is known about possible long-term problems. Studies in children showed the types of complications were similar to the ones seen in adults, the manufacturers said. The companies said the risks were acceptable given the benefits of treating symptoms of schizophrenia, which causes hallucinations and delusions, and bipolar disorder, which causes dramatic mood swings from manic episodes to depression. The conditions are "extremely serious and debilitating diseases" that cause "substantial, chronic suffering" for patients and their families, said Ihor Rak, vice president for clinical neuroscience at AstraZeneca. The FDA advisers were scheduled to vote Wednesday on whether the widely used medicines were effective and acceptably safe for various age groups. The agency will make the final decision but usually follows panel recommendations. Zyprexa is Lilly's top-selling drug with sales of $4.7 billion last year. Seroquel is the second-best-selling product for AstraZeneca with 2008 sales of $4.5 billion. Sales of Pfizer's Geodon topped $1 billion in 2008. Two similar drugs, Johnson & Johnson's Risperdal and Bristol-Myers Squibb Co's Abilify, are already cleared to treat youngsters with bipolar disorder or schizophrenia. All of the drugs are atypical antipsychotics, a class that has drawn scrutiny for risks such as weight gain and increases in blood sugar, raising concerns they might lead to diabetes. Consumer advocate Diana Zuckerman said pediatric studies included too few patients and some were as short as three to six weeks long for diseases that last decades. "These studies provide almost no useful information about long-term adverse reactions," said Zuckerman, president of the National Research Center for Women & Families. Lilly said the magnitude and frequency of weight gain, sedation and other side effects were higher in children treated with Zyprexa compared with adults. Nearly 90 percent of adolescents treated for at least 24 weeks saw their weight increase by at least 7 percent, the company said. The company is seeking approval of Zyprexa as a second-choice treatment in children. Seroquel's risks were similar in adults and children and "can be monitored and managed," said Liza O'Dowd, an AstraZeneca vice president. Pediatric studies showed small increases in blood pressure not found in adults, she said. For Geodon, Pfizer said risks were similar for adults and children, except for more sedation and sleepiness in kids. Pediatric studies showed "minimal effects on weight," said Phillip Chappell, leader of psychiatry products for Pfizer. Some FDA reviewers, in memos released last week, said an adult warning on Geodon about QT prolongation, a type of irregular heartbeat that can increase the chances of sudden death, should also mention the risk extends to children. Spokespeople for Lilly, Pfizer and AstraZeneca said the companies had no plans to advertise the pediatric uses directly to consumers. AstraZeneca and Lilly are seeking approval for their drugs for acute episodes of both schizophrenia and bipolar mania. Pfizer's application asks for approval only in bipolar disorder. A study of Geodon was stopped after it failed to show the drug was effective for teens with schizophrenia, Pfizer said. The company is no longer studying that use and will not seek approval for it, Pfizer spokesman Jack Cox said.