Baum Hedlund and Clients Testifed at FDA Antidepressant Hearings

Several Baum Hedlund staff and clients attended the three Food and Drug Administration (FDA) advisory committee hearings held in 2004 and 2006 on the subject of SSRI-antidepressants and their link to suicide. One of our attorneys testified at all three hearings and stated at one of the meetings, "Put me out of business for the right reasons. Warn about these drugs."

Victims of antidepressants and clients of Baum Hedlund also testified at the FDA hearings. They each told their story of how they tried to commit suicide while on an antidepressant or why they believe their loved one’s suicide was caused by an antidepressant.

The FDA heard their stories among many others, and also from lawyers and experts and subsequently decided on October 15, 2004 that a black-box warning should be placed on antidepressants that would alert health care providers to an increased risk of suicidality caused by antidepressants in children and adolescents. The FDA acknowledged that: "A causal role for antidepressants in inducing suicidality has been established in pediatric patients."

After the FDA hearing on December 13, 2006, the FDA on May 2, 2007 announced that it asked antidepressant manufacturers to expand the current black box warnings concerning the increased risk of suicidality in children and adolescents to include young adults, but only ages 18 to 24.

Unfortunately, this later warning, rather than simply and accurately informing the public that this side effect can occur in some people - no matter their age, instead gives the false perception that some age groups are entirely safe while others are not. Does a drug know how old a person is? It is unrealistic and unwise to think that a person is at risk the day before their 25th birthday, but then safe and no longer at risk of becoming suicidal while taking these drugs one day later.

 

February 2-4, 2004
FDA Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee regarding the risk of suicide in children and adolescents taking antidepressants.

The committee discussed reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). The committee considered optimal approaches to the analysis of data from these trials, and the results of analyses conducted to date, with regard to the question of what regulatory action may be needed pertinent to the clinical use of these products in pediatric patients. The committee agreed further research is needed on this topic.

Harry Skigis' FDA Testimony | Baum Hedlund's FDA Testimony

September 13-14, 2004
Follow-up to the February 2004 meeting - Joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee concerning the risk of suicide in children and adolescents taking antidepressants.

FDA officials discussed the issue of pediatric efficacy studies and the risk of suicidality involving antidepressants, particularly focusing on the SSRI and SNRI class of antidepressants including Paxil, Zoloft, Prozac, Luvox, Celexa, and Effexor. Over the course of two days, Baum Hedlund clients Kim Witczak and Beverly Hatcher testified among other victims, parents and experts. With this testimony and the combination of previous testimony from the PDAC's hearing in February 2004 and other evidence, the committee recommended that antidepressants include a "black box" warning, the FDA’s most severe warning, that antidepressants not only cause some minors to become suicidal, but have also failed to demonstrate that they relieve depression.

The committee voted 15-to-8 for a "black box" warning for children and adolescents after reviewing clinical-trial data that showed the drugs are twice as likely as a placebo to cause suicidal thoughts or behavior.

In addition, the FDA finally conceded that an investigation of the suicide risk in adults would be conducted as well. http://www.fda.gov/bbs/topics/news/2004/NEW01116.html

Baum Hedlund's FDA Testimony

December 13, 2006
FDA’s Psychopharmacologic Drugs Advisory Committee concerning the FDA’s Review of Suicidality Data in Adult Antidepressant Studies

The committee’s agenda at this meeting included discussions of the results of the FDA ongoing meta-analysis of suicidality data from adult antidepressant trials.

On May 2, 2007, the FDA announced that it has asked antidepressant manufacturers to expand the current black box warnings concerning the increased risk of suicidality in children and adolescents to include young adults (ages 18-24).

   

Kim Witczak's Testimony | Beverly Hatcher's Testimony
Rosemary Dorsett's Testimony | Ellen's Testimony
Baum Hedlund's FDA Testimony