Antidepressants prescribed to children should have "Black box" labels warnings, which are reserved for the most dangerous drugs, of the increased risk of suicide that they pose. This will happen mid-March, five months after the Food and Drug Administration ordered it.
To change the labels the agency sent letters telling the 14 companies that make antidepressants to add the boxes and produce guides about proven risks and benefits. The guides will be given to everyone picking up antidepressant prescriptions. It is important for transparency and trust that this information was available quickly."It's unfortunate that it's taken this long," says Joel Gurin, executive vice president of Consumers Union, a consumer advocacy group.
The companies then had to submit applications for the label changes. The FDA approved the changes and set a 30-day deadline for action. Approval was given in mid-February to the makers of Prozac, Zoloft and Celexa, Cruzan says and in mid-January to GlaxoSmithKline, maker of Paxil and Wellbutrin. These five antidepressants are the most widely prescribed drugs to children.
Only Prozac has been approved to treat childhood depression, but the other drugs can be prescribed legally as an off-label use. Even Prozac causes a 50% higher risk of suicidal behavior in kids, according to an FDA analysis released last fall.
Although there were no suicides among the 4,400 children involved in the studies reviewed by the FDA, the warnings say that about 2 in 100 children taking antidepressants are more likely to think about or try suicide when on these drugs.
The decision in October to order black boxes and medication guides came after eight months of mounting pressure by Congress and the pleas of dozens of parents who testified at two FDA hearings that antidepressants had contributed to their children's suicides.
After a hearing in September an FDA scientific advisory panel recommended the black boxes.