The US Food and Drug Administration (FDA) has directed all manufactures of anti-depressants to include warnings that the drug may increase the risk of suicidal thoughts and behaviour (suicidality) in children and adolescents.

US FDA has issued a Public Health Advisory recently announcing a multi-pronged strategy to warn the public about the increased risk of suicidality.

The agency is directing manufacturers to add a "black box" warning to the health professional labelling of all antidepressant medications to describe this risk and emphasize the need for close monitoring of patients started on these medications. FDA has also determined that a Patient Medication Guide (MedGuide), which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken, is appropriate, and is in the process of developing one.

FDA's letters to the manufacturers also discuss other labelling changes designed to include additional information about paediatric studies of these drugs. These labelling changes are applicable to the entire category of antidepressant medications because the currently available data are not adequate to exclude any single medication from the increased risk of suicidality.

A "black box" warning is the most serious warning placed in the labelling of a prescription medication. Until now, only ten drug products approved for children contained a black box warning about their use in children. The new warning language does not prohibit the use of antidepressants in children and adolescents. Rather, it warns of the risk of suicidality and encourages prescribers to balance this risk with clinical need, the FDA release says.

MedGuides are intended to be distributed by the pharmacist with each prescription or refill of a medication. FDA will work with the manufacturers of antidepressant medications to make the MedGuides available as soon as possible. In addition, FDA intends to work with manufacturers to implement "Unit of Use" packaging for all antidepressants as a means of ensuring that patients receive a MedGuide with every prescription or refill.

"Today's actions represent FDA's conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them. Our conclusions are based on the latest and best science," said Dr. Lester M. Crawford, acting FDA commissioner.

Prozac (Eli Lilly) is currently the only medication approved to treat depression in children and adolescents.