British Government Issues New Warnings Re: Use of antidepressant drugs for children


British Government Issues New Warnings Re: Use of antidepressant drugs for children

Tue, 23 Sep 2003

related link:
U.K. Government Document – New SSRI Warnings for Children

In light of evidence from previously unexamined data from controlled clinical trials, the British Committee on Safety of Medicines (CSM), an arm of the Medicines and Healthcare Products Regulatory Agency (MHRA), which is the equivalent to US FDA) has just issued two new warnings about the potential hazards posed by SSRI antidepressants for children and also for some adults.

(Check the AHRP website — the alert will be posted)

These new public alerts to British consumers make it abundantly clear that prior SSRI approval decisions — by both UK and US regulatory agencies — lacked consistency and lacked solid scientific evidence of these drugs safety. It is incomprehensible how the two agencies –FDA and MHRA-made conflicting licensing determinations for children-since the safety and efficacy data submitted from the manufacturers’ clinical trials to the FDA and MHRA was-or should have been–identical.

The SSRI antidepressants include: fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil / Seroxat), Citalopram (Celexa / Cipramil), fluvoxamine (Luvox / Faverin), and Effexor (an SNRI).

The CSM alert notes:

“No SSRI /SNRI is licensed in the UK for the treatment of depression in children and adolescents aged <18 years."

How do officials of the FDA justify the agency’s licensing Prozac for children when no other regulatory agency in the world has licensed any antidepressant for the treatment of depression in children ?

The CSM acknowledges that NO EVIDENCE exists demonstrating a benefit for children taking an SSRI. But the agency acknowledges that evidence does exist showing that the drugs pose serious risks of self-harm and suicide: compared to placebo the risk is 1.5 to 3. 2:

It is entirely unclear on what basis either regulatory agency in the UK or the US licensed one or another SSRIs for obsessive compulsive disorder (OCD). The British MHRA licensed Zoloft for the treatment of OCD for children 6 years and older, and Luvox for children 8 years and older. However, the agency now warns: “treatment should be initiated only by specialists.” The FDA, on the other hand, approved Eli Lilly’s SSRI, Prozac, for OCD, while the MHRA did not.

The CSM alert warns adult consumers and physicians about the possibility of increased suicidal thoughts and behavior, and about the possibility of experiencing severe withdrawal symptoms when attempting to stop taking any one of the SSRIs:

note: you may click on the text images for larger versions.