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'Black Box' Warnings on Antidepressants To Appear in Mid-March, Five Months After FDA Order
The labels for the five antidepressants most commonly prescribed to children will begin to include "black box" warnings this month to advise consumers that the medications could cause suicidal tendencies in individuals younger than age 18,... USA Today reports (Elias, USA Today, 3/2). In October 2004, FDA ordered pharmaceutical companies that manufacture antidepressants to add the warnings, which consist of a black section with white writing that appears at the top of prescription drug inserts distributed to physicians and patients. The black box warnings are the strongest that the federal government can implement before a ban. FDA ordered the warnings for antidepressants based on an analysis of 15 clinical trials that found a "consistent link" between the use of the medications and suicidal tendencies in children. (Kaiser Daily Health Policy Report, 1/14). The warnings state that about two in 100 children who take antidepressants are more likely to have suicidal tendencies. Joel Gurin, executive vice president of Consumers Union, said, "It's unfortunate that it's taken this long. It was really important for parents to have had this information. Getting it out quickly was important for transparency and trust." However, FDA spokesperson Susan Cruzan said the process for revision of a prescription drug label takes time. FDA must approve applications from pharmaceutical companies for label revisions, and companies have 30 days after they receive approval letters to make the changes, she said. FDA in mid-January sent an approval letter to GlaxoSmithKline, which manufactures Paxil and Wellbutrin, and in mid-February sent letters to the manufacturers of Prozac, Zoloft and Celexa (USA Today, 3/2).
"Reprinted with permission from kaisernetwork.org kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Celexa; Paxil CR; Prozac Weekly.
"Cutie neagrã" Avertismente pe antidepresive Pentru a apãrea la mijlocul lunii martie, cinci luni de FDA Comanda - 'Black Box' Warnings on Antidepressants To Appear in Mid-March, Five Months After FDA Order - articole medicale engleza - startsanatate
