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After a two-day hearing on the safety and efficacy of antidepressants in children, an FDA advisory panel voted to recommend that all antidepressants carry a black box warning to inform consumers that the drugs can cause suicidal thoughts and behavior in under-18s. The move overturns the FDA's previous stance, and drug companies will be concerned over the impact on sales.
The panel was unable to conclude that any antidepressant was risk-free, and recommended the warning be applied to all antidepressant classes, including new approvals. The FDA will make a decision on the recommendations within months. If the FDA does decide to include a black box warning, it will be written in consultation with leading drug makers. Pfizer [PFE], Lilly [LLY], GlaxoSmithKline [GSK.L] and Wyeth [WYE] all had drugs examined in the review and have supported the panel's recommendations.
Clinical trial data suggests that under-18s taking antidepressants have almost twice the risk of suicidal behaviors as those taking placebo, and that the drugs - apart from Lilly's Prozac, the only drug approved to treat major depression in children - do not work in this patient group. The data showed a varying amount of risk among the antidepressants, with Wyeth's Effexor having the highest risk. The recommendations could also impact Lilly's Cymbalta (duloxetine), which won approval for major depression last month.
Despite antidepressants' 2-3% increased chance of actual suicide, untreated depression itself carries a 15% risk. Experts now fear the black box will impede access to treatments. As a result, the panel has not recommended doctors be prevented from prescribing antidepressants to children.
The FDA has struggled with antidepressant labeling since GSK's alert last year about a significant increase in suicide-related events in those taking Paxil. The FDA subsequently advised doctors not to prescribe Paxil to under-18s. UK doctors were also banned from prescribing selective serotonin reuptake inhibitors to under-18s. However, last year, US physicians wrote 15 million antidepressant prescriptions for patients under 18, according to FDA data. After warnings issued in March, antidepressant prescriptions for children still increased by almost 8%.
A black box warning on antidepressants could also discourage direct-to-consumer advertising because, while such marketing is not prohibited, it requires that warnings be included, reducing the product's appeal. The panel's recommendation will mean reduced sales, but drug companies will have little choice but to accept it.
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