FDA proposes to expand labelling for antidepressants
2007-01-21
At an advisory panel meeting, the FDA proposed updating the labelling for antidepressants to warn of the risk of suicidal thoughts and behaviour in patients 24 years old and younger. Late Wednesday, the advisory panel voted 6 to 2 in favour of recommending that labelling for antidepressants be modified to reflect this risk.
Thomas Laughren, the agency's director of the division of psychiatry products, noted that "our current position is that we think we can extend the current warning language to extend the risk to young adults up to age 25," Bloomberg reports. The labeling for antidepressants already carries a warning of the risk of suicidal thoughts and behaviors for children and adolescents. The FDA also told the advisory panel that antidepressants' labels should recommend that patients of all ages who are taking antidepressants be monitored carefully.
source : U.S. Food and Drug Authority