Zyprexa, Seroquel and Geodon Get Wider Use Approval from the FDA - Children
Posted Jun 10 2009 10:48pm
The over all concern is with long term dosing, as children are not adults and the brains and bodies are still developing. BD
ADELPHI, Maryland (Reuters) – Three widely used antipsychotic medications appear safe and effective overall in treating children and teenagers with schizophrenia or bipolar disorder, a U.S. advisory panel said on Wednesday.
The Food and Drug Administration's panel of outside experts backed wider use of the pills -- Eli Lilly and Co's Zyprexa, AstraZeneca's Seroquel and Pfizer's Geodon -- but expressed concern over long-term effects the medications may have in younger patients.
The drugs are already approved for adults and are given to youngsters at a doctor's discretion, reaching $10 billion in combined annual sales. FDA approval would allow the drugmakers to market them specifically for children and teenagers.
Studies showed Zyprexa, Seroquel and Geodon generally have the same side effects in youth as in adults such as weight gain and sleepiness, the FDA said. Panelist agreed and noted the need for additional treatment options. But they said the question was whether over time there could be an impact on brain development and other reactions not seen in adults.