US antidepressants to carry suicide warnings
FDA will implement 'black box' warnings on risks for children.
The US Food and Drug Administration said on 15 October that it will require drug manufacturers to issue strong 'black box' warnings on all antidepressant medications.
The FDA said the warnings must indicate that the drugs may cause children and teenagers to exhibit suicidal thoughts and behaviours. The warnings will also indicate whether the FDA has determined that the medication being sold works in children.
Only one antidepressant, fluoxetine, sold as Prozac, has been approved by the FDA to treat childhood depression. However, physicians regularly prescribe other medications 'off label' to treat depressed children. Medicines for all kinds of ailments are prescribed off-label for children, but it does mean that the FDA has not officially approved them for such a use.
The FDA also said that it is issuing a patient medication guide, or MedGuide, which will be distributed to patients and their families, and will contain information and advice.
The FDA's actions come after a year of controversy over whether antidepressants cause suicide in children. Concerns have focused on newer types of drugs called selective serotonin reuptake inhibitors.
The decision to issue strong warnings follows a recommendation issued by an advisory committee to the agency on 14 September (see " FDA considers antidepressant risks for kids"). The committee said that evidence from clinical trials of antidepressants showed that 2-3% of children taking the drugs experienced suicidal thoughts and behaviours because of the drugs.
"These conclusions are based on the latest and best science and reflect what we heard from our advisory committee last month," said Lester Crawford, acting commissioner of the agency. "They also reflect what we have heard from many members of the public."
FDA officials also said they were concerned about the possibility that prominent warnings might scare patients away from seeking treatment for depression. They hope to manage this risk by asking parents to monitor their children closely during treatment.