Teen suicide warnings put on antidepressants

BY MARILYN ELIAS
GANNETT NEWS SERVICE

"Black box" labels warning that antidepressants increase suicidal behavior in children should be on those drugs widely prescribed to kids by mid-March, five months after the Food and Drug Administration ordered them, according to FDA documents.

"It's unfortunate that it's taken this long," said Joel Gurin, executive vice president of Consumers Union. "It was really important for parents to have had this information. Getting it out quickly was important for transparency and trust."

Changing the labels takes time, said FDA spokeswoman Susan Cruzan. The agency sent letters telling the 14 companies that make antidepressants to add the boxes and produce "medication guides" about proven risks and benefits. The guides will be given to everyone picking up antidepressant prescriptions.

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 letters went out in mid-February to the makers of Prozac, Zoloft and Celexa, Cruzan said. In mid-January, the letter went to GlaxoSmithKline, maker of Paxil and Wellbutrin. These five antidepressants are the most widely prescribed to children, according to IMS Health.

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 percent higher risk of suicidal behavior in kids, according to an FDA analysis out last fall.