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US FDA panel weighs antipsychotic drug use in kids
June 9, 2009
* Advisers weigh if 3 drugs should be approved for kids
* Makers say side effects acceptable in light of benefits
* Consumer groups say data inadequate (Adds company comments on advertising)
By Lisa Richwine
ADELPHI, Md., June 9 (Reuters) – 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.