"We do not feel it would be useful to describe these negative trials in labeling," FDA officials wrote in a letter to the company, "since these may be misinterpreted as evidence that Zoloft does not work."
FDA's Woodcock said agency officials had told Wyeth to scale back a label change that warned that the drug Effexor had been linked to suicidal thoughts, hostility and self-harm.
Rep. Greg Walden (R-Ore.) said the FDA should be encouraging drug manufacturers to disclose more information.
(Ron Winn -- AP)
"It was not very understandable," Woodcock said in an interview when asked why the FDA had found the Wyeth label objectionable.
Wyeth and other companies were instead asked to insert a general caution that physicians should carefully monitor the risk of suicide among all patients with depression. Agency officials said at the time that the caution was a reiteration of good clinical practice.
Joseph S. Camardo, senior vice president at Wyeth Pharmaceuticals, said company scientists had disagreed with the FDA on how to interpret the data in its labeling.
"We thought our proposal was reasonable, so it was a bit of a surprise," he said of the FDA ruling that substituted a less pointed warning.
In the agency's most recent internal review of the antidepressant studies, FDA scientist Tarek Hammad concluded in August that children taking Effexor had 8.84 times the risk of suicidal behavior or thinking compared with children taking sugar pills.
British authorities warned physicians last year not to prescribe a range of antidepressants to children. The FDA has called for a more cautious interpretation of the data, which an agency advisory committee is expected to discuss at a meeting next week.
Yesterday's hearings, which included testimony from officials from seven pharmaceutical companies, grappled with ways to make negative study results about drugs more accessible to the public. Recent proposals by manufacturers, medical journal editors and members of Congress have called for various schemes for publicly registering all drug trials and, in some cases, disclosing the results.