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Published on 10 June 2009

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Watchdog considers bipolar drugs

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The US medicines watchdog is to decide whether three pharmaceutical firms are allowed to target their antipsychotic drugs at children and teenagers.

Adults and young people with schizophrenia or bipolar disorder already use Eli Lilly and Co’s Zyprexa, AstraZeneca’s Seroquel and Pfizer’s Geodon, but the companies need a green light from the US Food and Drug Administration (FDA) before they can launch advertising campaigns aimed specifically at youngsters aged 10 years old or more.

Combined sales of the drugs already comes to around £6.22 billion ($10 billion), and it is thought that FDA clearance for wider use may boost revenue even further.

The FDA told a panel of outside experts that the medicines initially appeared effective for treating symptoms, but the watchdog is eager for advisers to consider the risks of reactions such as weight gain and sleepiness before deciding whether to recommend approval in younger patients.

Dr Thomas Laughren, director of the FDA`s psychiatry drugs division, said: “[Side effects] are of particular concern in paediatric patients primarily because these are lifelong disorders, and these children would face many decades of taking these drugs.”

Copyright © Press Association 2009

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