PFPC Daily - October 15, 2004

FDA bolsters anti-depressant warning

New 'black box' alert to warn on children's' suicide risk

CBS MarketWatch - October 15, 2004

WASHINGTON (CBS.MW) -- The Food and Drug Administration will require
anti-depressant drugs to carry a strongly worded warning advising of
a higher potential suicidal risk in children, the agency said Friday.


Drugs affected by the decision include GlaxoSmithKline's Paxil, Eli
Lilly & Co.'s Prozac and Pfizer's Zoloft.

The so-called "black box" warning -- the most serious that the FDA
can order to appear on drug labels -- will advise that children and
adolescents for whom anti-depressants have been prescribed be closely
monitored for more frequent suicidal thoughts and behaviors.

The FDA said it would also require that physicians distribute a
patient medication guide when prescribing anti-depressants. The
agency said it's now developing the guide.

In September, an advisory panel voted recommending that the FDA add
the black box warning to all anti-depressants, including
new-generation selective serotonin re-uptake inhibitors as well as
older therapies.

Most physician and patient groups supported the move, although some
experts have been concerned that the black box warning might scare
physicians away from prescribing the medications to patients who
stand to benefit from them.

In the wake of FDA's decision, the American Psychiatric Association
issued a statement, reiterating the group's "deep concern" that a
black box warning "may have a chilling effect on appropriate
prescribing for patients. This would put seriously ill patients at
grave risk."

The APA argued that data on prescribing anti-depressants show that
treatment rates are already down and noted that it's working with
non-psychiatric doctors, including pediatricians, to spread the word
about the new warning's potentially negative impact.

The group called on FDA to track the effects of the black box
warning, including any trends of increased suicidal tendencies in
patients "as a result of reduced access to medically necessary
treatment with anti-depressants."

The FDA first identified increased suicidal tendencies in children
being treated with anti-depressants last spring, when the agency was
reviewing pediatric study data submitted by GlaxoSmithKline for
Paxil.