In heart-wrenching testimony before federal drug regulators last February, parent after parent related how their teens had committed suicide after taking prescription antidepressants. In one case, a father told of how his 17-year-old hanged herself after seven days on Zoloft, which her doctor had stressed was safe.
Such tragic stories have helped fuel a campaign by some patient advocacy groups to pressure the Food and Drug Administration (FDA) to ban a family of widely prescribed antidepressants for anyone under 18. They say clinical studies show increased suicidal behavior and a track record that’s no better than placebos (sugar pills) in fighting depression. British regulators banned most antidepressants for minors last December.
Banning these drugs in the USA would be a premature move that could jeopardize the health of more than a million children getting relief from the misery of depression.
Instead, concerns raised about the drugs’ safety can be addressed through improved warning labels while more studies are conducted on their effects on children. That’s the sensible approach taken by the FDA.
The FDA says it has no proof the pills cause suicidal behavior in children. Even so, it asked drugmakers in March to add warnings to 10 widely used antidepressants that instruct parents and doctors to closely monitor behavior for such changes as increased anxiety, impulsiveness or aggression.
Evidence that antidepressants are not harmful for children include:
No suicides were reported in 25 studies of more than 4,000 children taking the pills. Many incidents of self-harm initially listed as suicide-related may have been misidentified, such as children slapping or superficially cutting themselves, FDA officials said.
A 2003 World Health Organization study found that the teen suicide rate dropped in 15 nations by 33% in the past 15 years, coinciding with the widespread use of the antidepressants. In the USA, the suicide rate among adolescents dropped 25% during the past decade, the Centers for Disease Control and Prevention reported June 11.
The American Academy of Child and Adolescent Psychiatry says the benefits of the pills outweigh the risks, and that links to suicidal behavior haven’t been established.
The debate has produced one positive result: calls that all clinical studies positive and negative be placed on a public registry so doctors and parents can review them. The American Medical Association endorsed the concept last week. That followed a suit filed June 2 by New York’s attorney general against GlaxoSmithKline, manufacturer of the antidepressant Paxil, for allegedly suppressing negative results from studies on the drug’s impact on children. Glaxo says it provided all studies to the FDA.
Supporters of a ban say evidence of the harmful effects these antidepressants have on minors is convincing. But they ignore the significant drop in the suicide rate since the medicine has been prescribed for children.
More studies focused on children will help the FDA reach a definitive conclusion. In the meantime, tougher warnings can help avert future tragedies.
Without more persuasive evidence of harm, banning antidepressants outright for children could leave too many anguished kids in the grip of debilitating depression.
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