10 November 2003 20:39 [Source: ICIS news]
WASHINGTON (CNI)--The National Toxicology Program (NTP) plans to release a draft report on Wednesday to examine potential reproductive and developmental dangers associated with the widely prescribed antidepressant drug fluoxetine hydrochloride.
The chemical compound is found in popular antidepressants Prozac and Sarafem. It originally entered the market during the mid-1980s as a serotonin reuptake inhibitor, NTP said.
NTP has also scheduled an expert panel meeting for 3-5 March in Alexandria, Virginia that will evaluate more deeply findings by researchers in the coming months.
NTP’s Center for the Evaluation of Risks to Human Reproduction (CERHR), both of which are part of the US Department of Health and Human Services, said it selected fluoxetine in part because enough reproductive studies of the compound have been conducted and a sufficient amount of human exposure and prescription data is available.
The drug is prescribed to treat premenstrual dysphoric disorder (PMDD), potentially increasing the number of exposures for women of childbearing age. The US Food and Drug Administration (FDA) recently approved Prozac for use in 7-17 year-olds for depression and other mental disorders, increasing the exposure to children, NTP said.
NTP’s examination of the drug will be the first comprehensive public review of the popular antidepressants outside of those conducted by the FDA. Most of the FDA’s findings are considered proprietary and available to the public.
"The public health question was big enough to deserve our attention," CERHR director Michael Shelby told CNI today.
"We’re not setting out to condemn Prozac use," he said. "If it is safe and there’s no reason for concern then that’s important, but if it’s not safe then that information should be known."
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