The U.S. Food and Drug Administration (FDA) ordered drug makers on Wednesday to update existing black box warnings on their antidepressants, saying these medications need new warnings about increased risks of suicidal thoughts and behavior among young adults.
The agency recommended the so-called "black box warnings" about antidepressants and suicidal thoughts and behaviors that currently cover children and teens be expanded to young adults up to 24 years of age.
The move comes as a part of FDA’s actions involving antidepressant use in children and young adults.
The US regulators asked the makers of 36 antidepressants to extend the existing black box warning to cover people ages 18 to 24 when they first use the drugs. The expanded warning would apply to adults during the first month or two of treatment with the drugs, the health agency said.
During initial treatment young adults on antidepressant medication face a substantial increased risk of experiencing suicidal tendencies (suicidal thinking and behaviour), the federal health regulator warned.
The expanded warnings, which will appear in a black-ruled box displayed prominently on the prescribing information, would note that studies have not found an increased suicide risk in adults older than 24, and people 65 and older have shown decreased risk of suicidal tendencies. The changes would also emphasize that depression and some other serious psychiatric disorders are the major causes of suicide.
"Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks," said Steven Galson, director of FDA's Center for Drug Evaluation and Research.
The proposed labeling changes apply to the entire category of antidepressants, including Lexapro (Forest Laboratories Inc.), Paxil (GlaxoSmithKline PLC), Prozac (Eli Lilly and Co.) and Zoloft (Pfizer Inc.). Manufacturers of theses medication will now have 30 days of time to submit their revised product labels to the FDA for review.
FDA’s recent announcement is a follow-up of recommendations made in December by its advisory committee. According to a federal advisory panel, which voted 6-2 to recommend the warnings, strong warning labels on antidepressants about suicide risk should be extended to include not only children and adolescents but also young adults.
The panel recommended the drugs' prescribing information be revised to inform doctors and patients about suicide risks seen in the trials of young adults during their initial months of treatment.
In 2005, the FDA recommended 'black box' warnings be placed on all antidepressant medications indicating that they may result in increased risk of suicidal tendencies in children and adolescents only. Now on its advisory committee’s recommendations FDA has proposed to include the 25-years-old adults in the warnings.
Nearly 16 million people in the United States take antidepressants each month, according to the American Psychiatric Association.
Americans spent $13.5 billion on antidepressants last year, as per the data compiled by IMS Health Inc., a research firm in Fairfield, Connecticut. The drugs include Forest Laboratories Inc.'s Lexapro, Lilly's Cymbalta and Pfizer Inc.'s Zoloft.
About 11 percent of adults younger than 44 years, or 12 million Americans, received at least one prescription for an antidepressant in 2006, as per the estimates by Medco, the largest prescription manager.