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FDA Alters Tack On Children and Antidepressants

Aug 21, 2004 | Washington Post A Food and Drug Administration reexamination of data linking the pediatric use of some antidepressants to increased suicidal tendencies has once again found a connection, and the agency is actively considering new warnings to highlight the risk.

In a memo released by the agency as part of its preparation for an expert advisory panel meeting on the subject next month, FDA medical officer Andrew D. Mosholder said that he still sees a significant association between short-term use of antidepressants by children and an increase in their thoughts of suicide.

The agency had reacted cautiously to Mosholder's first report on the association in March and asked for additional outside analysis. Based on that new analysis of data from trials of antidepressant drugs, Mosholder found a similarly significant correlation that children using the drugs were 1.8 times as likely to have suicidal tendencies as depressed children who took placebos.

Nonetheless, the agency said in a "talk paper" that it remained unclear whether the connection was real and serious. Despite the finding of an increased risk of suicidal thinking in children on antidepressants, "there remain inconsistencies in the results, both across trials for individual drugs and across drugs. Thus, an overall interpretation of these findings represents a substantial challenge," the agency said.

The agency has scheduled an advisory panel of outside experts to review the information Sept. 13 and 14 and make recommendations on whether and how the antidepressants should be prescribed for children.

Yesterday's release by the FDA of Mosholder's second report, along with numerous other papers on the subject, represented a dramatic change by the agency. Critics, including Sen. Charles E. Grassley (R-Iowa), have complained that the FDA was moving too slowly on the issue of children and antidepressants and was not sharing potentially important information with the public.

"Doctor Mosholder's initial findings have been confirmed and reconfirmed," Grassley said yesterday in a statement. "His important work represents the kind of scrutiny the Food and Drug Administration must provide for the public's safety and well-being. When there are known risks with a drug or class of drugs, the information must be made available in a timely way."

In December, British regulators warned doctors and patients against the use of antidepressants other than Prozac for children, saying that the risks outweighed the benefits. The FDA has studied similar information and concluded, as an agency, that there still is not clear evidence that the antidepressants are harmful to children.

Although only Prozac has been approved by the FDA for use by children, doctors are believed to be prescribing similar medications to increasing numbers of youngsters.

In March, the FDA told physicians to closely monitor patients of all ages for warning signs of suicide when they start taking antidepressants or when they change dosages. Antidepressants are known to cause agitation, anxiety and hostility in a small number of patients, and some whose severe depression has caused them to be lethargic might become suicidal as the drugs cause the depression to lift.

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