Healthy Skepticism Library item: 105

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Lawmaker Seeks Data on Antidepressants for Kids
Reuters 2004 Feb 3

Full text:

A U.S. lawmaker asked four drug makers on Tuesday to tell a House committee about any unpublished clinical trials involving antidepressant treatment for children amid a probe into whether some drugs raise the risk of suicide in youngsters.

Pennsylvania Republican Rep. James Greenwood, head of the House Energy and Commerce investigations subcommittee, said in a letter to the pharmaceutical companies that he wanted the data “in light of protecting the public health of children and/or the need to expedite public and physician confidence in the use of antidepressants.”

The letters were sent to Eli Lilly and Co., Wyeth, GlaxoSmithKline Plc and Pfizer Inc.

Drug makers are not required to release findings from studies not published in medical journals, which has upset critics who charge the companies with keeping unfavorable data secret.

“Critics and even some supporters of antidepressants for children want clinical trial information put in the public domain,” Greenwood wrote.

Only Prozac is approved for treating children with depression, but doctors can prescribe any antidepressant on the market for children as well as adults.

The Food and Drug Administration (news – web sites) is investigating whether the newest antidepressants increase the risk of suicide in children and teenagers. FDA officials have urged careful monitoring of youngsters who are prescribed antidepressants while regulators try to determine if they are linked to an elevated suicide risk.

Wyeth, which makes antidepressant Effexor, last August sent a letter telling doctors the drug was not recommended for children and noted reports of hostility and suicidal behavior in pediatric studies.

“The data the company has on this topic is what is reflected in our August 22 letter and our current product labeling,” Wyeth spokesman Doug Petkus said, adding the company was evaluating Greenwood’s letter.

GlaxoSmithKline “expects to fully cooperate” with Greenwood’s request, company spokeswoman Mary Anne Rhyne said.

Spokespeople for Lilly and Pfizer did not immediately respond to requests for comment.