LONDON - Children and adolescents
should not be given the antidepressant Paxil, British health
regulators said yesterday after new research indicated that the
drug's risk of suicidal thoughts and self-harm was higher in
The drug, which is called Seroxat outside the United States and
is made by the British-based GlaxoSmithKline (whose U.S.
headquarters are in Philadelphia), is not licensed for use in
children or teenagers anywhere in the world. However, some doctors
give it to treat depression, based on their own judgment.
The new research, provided to Britain's Medicines and Healthcare
products Regulatory Agency by GlaxoSmithKline, does not apply to
adults, the regulators said.
Britain's Department of Health said the evidence provided by the
drug company, from nine studies based on more than 1,000 youngsters,
showed there was an increase in the rate of self-harm and
potentially suicidal behavior in those under 18 taking Paxil.
GlaxoSmithKline spokesman David Mawdsley said the rate of a
collection of emotional side effects, ranging from mood swings and
increased crying, to suicidal thoughts and self-harm, was twice as
high in the Paxil group as in those taking a fake pill. A total of
3.2 percent of patients on Paxil had the emotional side effects,
compared with 1.5 percent of those taking the dummy pill.
"It has become clear that the benefits of Seroxat in children for
the treatment of depressive illness do not outweigh these risks,"
the government said in a statement. "Young people under 18 years
currently taking Seroxat for depression should consult their
Alasdair Breckenridge, chairman of the regulatory agency, said
Seroxat's benefits for depressed adults were well-known.
"It is important that patients who are benefiting from Seroxat
should not be alarmed by the announcement and should continue their
treatment," he said.
It is estimated that almost 17 million people worldwide have been