Panel Urges Warning on Some Antidepressants
Panel Urges Warning on Some Antidepressants
Experts Recommend 'Black Box' to Warn of Potential for Suicidal Behavior
Sept. 14, 2004 -- Experts are urging the FDA to require strong warnings on nine popular antidepressant drugs because of evidence that they increase the risk of suicidal behavior in children.
The recommendation, issued by an FDA advisory panel Tuesday, applies to nine antidepressants that affect the brain chemical serotonin. The warning includes the most popular class of antidepressants, called SSRIs or selective serotonin reuptake inhibitors.
The FDA is also moving to require new warnings on other classes of antidepressant drugs including tricyclic drugs and MAO inhibitors.
Antidepressants included in the advisory are:
"We are unable to conclude that any single antidepressant agent is free of risk at this time," the panel says.
The committee stopped short of recommending banning the use of the drugs in children but voted 23 to 8 to urge the use of stark "black-box" warnings on all package inserts and drug advertisements warning of increased suicide risk in children. A black box warning is the strongest type of warning that the FDA can require on a drug's labeling information.
Some members opposed the black-box warning, saying it would scare families and doctors from seeking treatment for children. But others say that the warnings were appropriate given the risks and limited known effectiveness of antidepressants in children.
Analysts unveiled a pair of studies yesterday showing that these antidepressants may increase children's risk of suicidal thoughts or behaviors by as much as 2% to 3% over what is expected in patients with major depression.
No cases of completed suicide were recorded in any of 23 drug company trials reviewed by the FDA. But many parents of children who have killed themselves while taking antidepressants have claimed a causal link.
The reviews and officials' statements yesterday went against a years-old position by the agency and drugmakers suggesting that any increased risk of suicide was caused by children's underlying depression and not their medications.
"The fact that they all lean the same way ... that's what makes a powerful argument," Robert Temple, the FDA's head of scientific investigation, said Monday.
Panel Urges Warning on Some Antidepressants
Experts Recommend 'Black Box' to Warn of Potential for Suicidal Behavior
Sept. 14, 2004 -- Experts are urging the FDA to require strong warnings on nine popular antidepressant drugs because of evidence that they increase the risk of suicidal behavior in children.
The recommendation, issued by an FDA advisory panel Tuesday, applies to nine antidepressants that affect the brain chemical serotonin. The warning includes the most popular class of antidepressants, called SSRIs or selective serotonin reuptake inhibitors.
The FDA is also moving to require new warnings on other classes of antidepressant drugs including tricyclic drugs and MAO inhibitors.
Antidepressants included in the advisory are:
"We are unable to conclude that any single antidepressant agent is free of risk at this time," the panel says.
The committee stopped short of recommending banning the use of the drugs in children but voted 23 to 8 to urge the use of stark "black-box" warnings on all package inserts and drug advertisements warning of increased suicide risk in children. A black box warning is the strongest type of warning that the FDA can require on a drug's labeling information.
Some members opposed the black-box warning, saying it would scare families and doctors from seeking treatment for children. But others say that the warnings were appropriate given the risks and limited known effectiveness of antidepressants in children.
Analysts unveiled a pair of studies yesterday showing that these antidepressants may increase children's risk of suicidal thoughts or behaviors by as much as 2% to 3% over what is expected in patients with major depression.
No cases of completed suicide were recorded in any of 23 drug company trials reviewed by the FDA. But many parents of children who have killed themselves while taking antidepressants have claimed a causal link.
The reviews and officials' statements yesterday went against a years-old position by the agency and drugmakers suggesting that any increased risk of suicide was caused by children's underlying depression and not their medications.
"The fact that they all lean the same way ... that's what makes a powerful argument," Robert Temple, the FDA's head of scientific investigation, said Monday.
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