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For Immediate Release April 27, 2004 Washington, D.C. - Senator Chris Dodd today wrote to Lester Crawford, Acting Commissioner of the Food and Drug Administration, to voice his concerns about the effectiveness of antidepressants on children. The letter is a follow-up to a letter Dodd and nine Senate colleagues sent to Crawford’s predecessor, Mark McClellan, at the beginning of March. In the letter, Dodd points out the growing questions surrounding antidepressant use in children and the importance of determining the appropriate use of antidepressants in children. “Families bearing the incredible burden of caring for a depressed child are desperate for answers, and I write today to urge the FDA to provide those answers with all possible haste,” Dodd wrote. “These families and their physicians must have all the necessary information to do what is best for children suffering from depression.” The full text of the letter is below. Lester M. Crawford Dear Acting Commissioner Crawford: On April 23, 2004 the Washington Post reported on the results of a study published in the Lancet, a British medical journal, showing an increase in the risk of suicidal behavior among children taking four antidepressants. Also that day, the New York Times published an editorial expressing serious concerns about the use of antidepressants in children and adolescents, and asking whether the benefits of antidepressants outweigh the risks to our nation's youth. I bring these two articles to your attention as examples of the growing questions surrounding antidepressants, and specifically the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). SSRIs are prescribed to millions of American children each year, and that number continues to increase dramatically. A study in the April issue of the journal Psychiatric Services concluded that antidepressants use is exploding even in children of preschool age. And yet questions about the safety and effectiveness of SSRIs in children persist. Families bearing the incredible burden of caring for a depressed child are desperate for answers, and I write today to -urge the FDA to provide those answers with all possible haste. These families and their physicians must have all the necessary information to do what is best for children suffering from depression. On March 1, I joined with nine of my Senate colleagues to send a letter to your predecessor, Mark McClellan, requesting that the FDA take several steps to answer the questions surrounding SSRIs. A copy of that letter is attached. Among other things, we urged the FDA to consider invoking its authority to require additional testing of SSRIs, so that it can be determined whether or not these drugs really do help our children, and to ensure that they are indeed safe. Since our earlier letter was sent, the questions have only increased, and further questions have also been raised about FDAs handling of this issue. As we said in our earlier letter, it is imperative that the questions surrounding SSRIs be answered as quickly as possible. If these drugs do indeed increase suicidal ideation, physicians and the public must be made aware of this risk as soon as possible. It is equally important to discover the truth in the case that SSRIs do not pose a threat to children's well-being, so that doctors can continue to prescribe these life-saving medicines without fear. In the current environment of uncertainty, there is a legitimate concern that children who now benefit, or who may benefit, from SSRIs will be inappropriately denied access to these drugs. Given recent developments, including the study published in The Lancet, I urge you to take our earlier recommendations into account, and to take all necessary steps to determine, once and for all, the appropriate use of antidepressants in children. I also ask that, as soon as possible, you share with me and my staff your plans for addressing this issue. I am willing to do whatever I can to help you in this matter so that families can be confident that the care that their children receive will not cause more harm than good. If you have any questions, please do not hesitate to contact Ben Berwick of my staff at (202) 224-2823. Sincerely, Christopher J. Dodd [Editors Note: Reporters interested in obtaining the earlier letter to FDA should contact press office.] -30- –
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