the FDA muzzled antidepressant critic
the new york times reported today that top officials from the US food and drug administration concede the agency prevented an expert from testifying at a february public hearing about his belief that commonly prescribed antidepressants caused children to become suicidal.the officials reportedly stand by their decision, calling dr andrew mosholder's findings 'alarmist and premature,' in the words of mple.
fda associate director dr robert temple told the newspaper that "if you get it wrong and over-discourage the use of these medicines, people could die," denying that the agency was trying to keep important information from the public.
the US house of representatives' energy and commerce committee plans to investigate the fda's actions, according to the associated press.
mosholder, an fda epidemiologist, had been charged with analyzing twenty-two studies involving more than 4,000 children and seven antidepressants. he concluded that children on certain medications known as selective serotonin reuptake inhibitors (SSRIs) were almost twice as likely as those given placebos to become suicidal, the times reported. frequently prescribed SSRIs include paxil and prozac, of which the latter is the only medication in its class to be fda-approved for use in children.
the fda said it is conducting its own review of mosholder's conclusions. in the interim, the agency has warned that patients of any age should be carefully monitored when they begin antidepressant treatment or change dosages.
via HealthDay.
