The warnings would be the strongest in the US Food and Drug Administration's arsenal.
Advisors to the US Food and Drug Administration have asked the agency to add tough warnings to antidepressant medications, saying the drugs cause some children to become suicidal.
The advisory committee said it was concerned by data from 24 clinical trials showing that most antidepressant medications do not work in children. The data, most of which has not been published in peer-reviewed journals, also showed that these drugs as a class increase the risk of suicidal thoughts and behaviors in children.
“We have very strong evidence of harm and not good evidence of efficacy, and I know many practitioners are convinced these drugs work,” said Thomas Newman, an epidemiologist and pediatrician at the University of California in San Francisco.
We have very strong evidence of harm and not good evidence of efficacy. Thomas Newman, University of California in San Francisco
On 14 September, the committee voted 15 to 8 in favor of a so-called 'black box' warning that would inform patients and doctors about the risks.
Drug companies say the warning may scare away children who need the treatment. But the drugs' critics claimed victory after the hearing, saying the episode underscores the need for full disclosure of data from clinical trials.
The controversy over antidepressant use in children has accelerated the push for a clinical trial registry. On 8 September, the editors of 12 leading medical journals announced that trials published in their journals must be registered at the outset in a public database.
Their announcement came one day after the pharmaceutical industry trade organization PhRMA said it plans to set up a voluntary database where companies can post results from clinical trials. At a congressional hearing on 9 September, Eli Lilly executive John Hayes explained why the pharmaceutical industry is now eager to act: “There is clearly a societal crisis in terms of the credibility of drug company results,” Hayes said.
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Check, E. US panel recommends 'black box' warnings for antidepressants. Nat Med 10, 1005 (2004). https://doi.org/10.1038/nm1004-1005b
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DOI: https://doi.org/10.1038/nm1004-1005b
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