Wyeth supports FDA recommendation to strengthen antidepressant labeling

Sep 16 2004

Statement by Wyeth Pharmaceuticals supporting the U.S. Food and Drug Administration (FDA) Joint Advisory Committee’s recommendation to strengthen the product labels across the antidepressant category regarding use in the pediatric population.

Wyeth will continue to provide safety information broadly and in a consistent way to physicians, as well as work with the FDA on its review of the safety and use of antidepressants in the pediatric population. Wyeth will discuss with the Agency how to implement the recommendations of the Committee to provide warnings and additional information to physicians, as well as to patients and their parents. The Committee’s recommendation will ensure continued access by physicians to these drugs for children suffering from depression.

With more than two million children and adolescents in the United States suffering from depression, it is critical that physicians have treatment options that allow for the use of antidepressants in the pediatric population if the physician believes it to be appropriate, is aware of the significant safety concern information, and is able to monitor these patients appropriately.

“We must not lose sight of the research, which suggests that the increased use of antidepressants may be associated with a reduction in the number of suicides in the pediatric population. Physicians need to assess the risks and benefits of antidepressant therapy in order to make appropriate treatment decisions for each patient,” says Moira Rynn, M.D., University of Pennsylvania School of Medicine.

The Effexor and Effexor XR labels have always included information on the possibility of a suicide attempt, which is inherent in depression, and that close supervision of high-risk patients should accompany initial drug therapy. Wyeth has and will continue to take a leadership role in communicating information to health care providers and consumers regarding important safety information in the pediatric population. In August of 2003, Wyeth sent a letter to over 450,000 health care professionals advising them of the Company’s decision to update the prescribing information of Effexor and Effexor XR to include a precaution about usage in children and adolescents. Wyeth also updated its consumer Web site with this important safety information. In June 2004, Wyeth sent a letter to over 450,000 health care professionals to inform them about the class labeling including the suicidality warning for antidepressants requested by the FDA.

“It also is important to note that in clinical studies in adults with depression, Effexor/Effexor XR showed no increase in the emergence or worsening of suicidality on the HAM-D suicide item score vs placebo,” says Joseph Camardo, M.D., Senior Vice President of Medical Affairs, Wyeth Pharmaceuticals.