–September 17, 2004
Though safety questions have been raised for years, FDA officials first became aware of possible links between the use of popular antidepressants and suicidal behavior in May 2003. At the time, critics alleged the drug agency was slow to acknowledge the potentially deadly risks and failed to adequately consider its own researchers’ findings. An FDA analysis had concluded two or three out of every 100 young antidepressant users might be facing an elevated risk of suicidal thoughts or actions.
The use of antidepressants amongst children and teenagers has been widely controversial because of the failure for studies to show its efficacy and safety. Prozac is the only antidepressant to be FDA approved for pediatric use and been proven to work in children. The practice of off-label sales is widely used, allowing doctors to prescribe drugs for treatment methods it has not been FDA approved to specifically treat if found effective. Many doctors believed antidepressants, though not approved for pediatric use, showed signs of providing beneficial symptom management.
On September 16, 2004, the FDA said it “generally supports” advisory committee’s recommendations. The Pediatric Advisory Committees and Psychopharmacologic Drugs voted on September 14th 15-8 urging the FDA to require a “black box” warning to all nine antidepressant drugs studied, including Prozac, Paxil , Wellbutrin, Zoloft , Celexa, Effexor, Luvox and Remeron, as well as older antidepressants such as tricyclics. A black box warning is the strongest agency issued drug warning beneath banning a drug.
The committees had reviewed data from 24 trials involving pediatric use of nine different antidepressants. The FDA has said it has begun work to adapt new labeling and providing patients with more information when the antidepressants are dispensed.
If you or a loved one has experienced serious side effects from antidepressants, please contact us to learn your legal rights.
