Healthy Skepticism Library item: 7115
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
Richwine L.
U.S. panel to weigh depression drug risk for adults
Yahoo Finance 2006 Dec 13
http://biz.yahoo.com/rb/061213/antidepressants_suicide.html?.v=1
Abstract:
WASHINGTON (Reuters) – Advisers to the U.S. government will consider on Wednesday if taking antidepressant drugs may raise the risk of suicidal behavior in some adults just as it appears to in children and teens.
A recent Food and Drug Administration analysis found use of the medicines seemed to increase the chances of suicidal thoughts and actions in adults up to age 25. In older adults, the drugs appeared to reduce suicidal behavior.
Antidepressants include Pfizer Inc.‘s (NYSE:PFE – News) Zoloft, Eli Lilly and Co.‘s (NYSE:LLY – News) Prozac and Cymbalta and Wyeth’s (NYSE:WYE – News) Effexor. Sales of antidepressants topped $12.5 billion in 2005, according to data from health information company IMS Health.
The drugs come with strong warnings that they may trigger suicidal thoughts and attempts in some children and teens. In clinical trials of nine antidepressants, 4 percent of patients who took the drugs reported suicidal thoughts or behaviors, compared with 2 percent who were given a placebo.
On Wednesday, the FDA will ask a panel of outside experts for input about the new analysis of the risk for adults and if warnings should be updated. The FDA review found the chances of suicidal thoughts or behavior among adults younger than 25 “approaches that seen in the pediatric population.”
The issue has caused controversy for years. Complicating matters is that suicidal thoughts or behaviors can be symptoms of depression itself — an illness that can leave patients feeling anxious, sad, and hopeless, with less interest in activities and decreased appetite.
Many psychiatrists have lobbied against tough warnings on antidepressants, saying the strong language may dissuade too many people from effective treatment.
“There is a danger when we paint a medicine as so scary or so potentially dangerous that people avoid it,” said Carolyn Robinowitz, a psychiatrist in Washington and incoming president of the American Psychiatric Association.
Patient groups and relatives of people who committed suicide said they would argue to the FDA panel that there is enough evidence for the agency to extend the warning for children to adults of all ages.
The FDA usually follows recommendations from its advisory panels.
Officials ordered new warnings for youth on antidepressants in 2004. The new analysis of adult use spanned 372 clinical trials involving almost 100,000 patients.
Pfizer has said it found no higher rate of suicidal behavior in adult or pediatric patients who took Zoloft in short-term clinical trials. Lilly said it was working with the FDA to better understand the safety and effectiveness of antidepressants.
Other makers could not immediately be reached for comment.