EU Regulators Warn Over Paediatric SSRI Usage

Fledgling European Union (EU) drug regulator EMEA has issued a stark warning on the prescription of antidepressants to children and adolescents. The body cited studies indicating a higher risk of suicidal and aggressive behaviour among young people taking the widely-prescribed serotonin-selective reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) classes of depression and anxiety treatments.

The warnings could lead to stronger labelling requirements on a number of leading drugs, including Eli Lilly's Prozac (fluoxetine), Solvay's Luvox (fluvoxamine), Pfizer's Edronax (reboxetine) and Zoloft (sertraline), Wyeth's Effexor (venlafaxine), and GlaxoSmithKline's Paxil (paroxetine). The drugs are also likely to be recommended by EMEA's Committee for Human Use Medicinal Products (CHMP) for child and adolescent sufferers only in their approved indications.

A number of drugs have escaped the committee's recommendation for full relabelling and side-effect warnings, including Eli Lilly's Cymbalta (duloxetine). In general, the committee noted that doctors should make clinical need their strongest priority when prescribing, although professionals should closely monitor any early-stage side effects.

Notably, the CHMP's calls for stricter product information reportedly conflict with advice given by UK drug regulator MHRA in late 2003. At the time, the agency said risk-benefit analyses did not favour prescriptions of Celexa, Effexor, Lexapro, Paxil, Remeron and Zoloft. However, the MHRA did issue a favourable opinion of Prozac, and is now understood to be seeking a revision to the EU agency's recommendations on the drug.

Nevertheless, both agencies are likely to agree on safety as a key priority on the eventual shape of guidance on SSRIs and SNRIs, in the wake of a series of recent controversies linking antidepressants to a spate of adolescent suicides.