Parents Refuse To Allow Children To Participate in NIH-Sponsored Antidepressants Clinical Trial
Some parents are choosing not to allow children who have attempted suicide to take antidepressants in an NIH-sponsored clinical trial, after an FDA advisory panel recommendation that the agency put a black box warning on the drugs' labels to indicate that they are linked to suicidal behavior in children, the AP/Akron Beacon Journal reports (Henderson, AP/Akron Beacon Journal, 9/19). The advisory panel on Sept. 14 voted 15-8 to recommend that all antidepressants carry a black box warning -- the strongest warning issued by the government -- to inform consumers that the drugs can cause suicidal thoughts and behavior in patients under age 18. A black box warning is a black section with white writing that appears at the top of drug inserts distributed to physicians and patients. On Sept. 13, FDA officials said that an analysis of 15 clinical trials -- some of which were not made public for years -- has found that there is a "consistent link" between the use of any kind of antidepressant and suicidal tendencies in children (California Healthline, 9/15).
In the NIH clinical trial, principal investigator Graham Emslie and colleagues are trying to determine if medication or behavioral therapy, either alone or combined, can prevent future suicide attempts. Emslie noted that 15% of children diagnosed with depression take medication to treat the problem and said, "We're trying to increase the number who are treated," adding that the recommendation for black box labeling "is definitely not going to help."
As a prerequisite for trial participation, children in the study must have attempted suicide within the past 45 days. Parents of two children have refused to let them participate because of the warning, the Journal reports. "I don't think it was isolated. I think it will continue," Emslie said of the refusals (Akron Beacon Journal, 9/19).