Antidepressant drugs trimmed black in the United-States

Added on October16th, 2004 at 8:04 AM

October 16th, 01:11 am.

On Friday, the American administration in charge of food and pharmaceutical control (FDA – Food and Drug Administration) decided to enforce the most definite possible warnings against increased risk of suicidal leanings with young peple treated with anti-depressant drugs. The package of these drugs will now have to include a warning trimmed black, « black box », which is the highest of those used by the FDA to warn medical doctors as well as patients against the potential dangers of such a treatment. As the FDA had already given to clearly understand it, it followed the recommandations of a committee of independent experts that had reached a decision last September, by 15 votes to 8 in favour of such a measure.

« This decision results from the conclusions of the FDA regarding the increased risk of suicidal thoughts and the necessity to inform medical doctors who prescribe these anti-depressant drugs as well as the children and teenagers whom they are directed to », the FDA interim representative Dr Lester Crawford declared in a release.

« Our conclusions are based on the most recent and best available scientific datas », he added.

« They reflect what we have heard from our committee of experts as well as from the public », Dr Crawford explained.

He also pointed out that the FDA had tried to balance the increased risk of suicidal thoughts and the proven positive effects of the anti-depressant drugs to treat depressive children and teenagers.

Dr Crawford insisted that, « we still believe that these drugs are efficient when used in an appropriate way ».

The conclusions of the committee were based on a series of clinical tests made on more than 4,000 young people by the manufacturers of the five main anti-depressant drugs prescribed in the United-States.

These studies have shown that for a youngster taking theses anti-depressant drugs, the risk to have suicidal thought was twice as high as for a youngster who had been administered placebos. The FDA added that no suicide happened in this group.

But several parents whose child committed a suicide after taking anti-depressant drugs, had been heard by the FDA committee of experts.

These searchers explained that according to the studies mentioned above, Celexa, Prozac and Zoloft show the smallest risk to increase suicidal thoughts. On the contrary, Luvox, Effexor and Paxil shew they provoked the most numerous leanings to suicide.

Prozac is the only anti-depressant drug authorized to heal depressive youngsters.

But the FDA said that the new warning should appear on all the anti-depressant drugs on sale in the United-States.

The speed at which the FDA made this decision — one month after the recommandations by the experts — is unusual.

It happens at the time when the agency is under a fire of criticisms for the current lack of anti-flu vaccines and the recent withdrawal from the market of Vioxx, an anti-inflammatory drug, because of heart risks it presented.

© AFP