ritish drug regulators warned yesterday that GlaxoSmithKline's
popular antidepressant Paxil causes depressed children to become
more suicidal and should not be prescribed for them.
That conclusion came from the combined results of nine studies on
Paxil, known as Seroxat in Britain, that the company recently
submitted to British regulators.
"It has become clear that the benefits of Seroxat in children for
the treatment of depressive illness do not outweigh these risks,"
the statement from the British government's Medicines and Healthcare
Products Regulatory Agency said. "The implications of the new
pediatric data on the safety of paroxetine (Paxil) in the adult
population remains under close review."
Alan Metz, vice president for clinical development at Glaxo, said
the company was not warning American doctors against using the drug
for depressed children. He noted that Paxil was not approved in the
United States for treating children but that many doctors prescribed
the drug for children anyway.
"It's difficult for me sitting here to tell doctors what they
should do with their patients," Dr. Metz said.
Glaxo, the British drug maker, has applied for permission from
the Food and Drug Administration in the United States to sell Paxil
to children who suffer from obsessive compulsive disorder. That
application is pending. Paxil has become increasingly controversial
The British drug agency recently required Glaxo to remove a
statement on its patient label saying that the drug was not
Patients who stop taking Paxil suddenly often experience
dizziness, abnormal dreams, headaches and nervousness. In Britain,
these are called "withdrawal symptoms" and in the United States they
are called "discontinuation symptoms," Dr. Metz said.
Paxil is part of a class of drugs that includes Prozac and
Zoloft. For years, lawsuits have contended that the drugs tend to
increase violence and suicidal thoughts in vulnerable populations,
but the makers of the pills have long denied this. Two years ago, a
Wyoming jury awarded $6.4 million to the family of a patient taking
the pill who killed his wife, daughter and granddaughter.
According to the studies, patients taking Paxil were 1.5 to 3.2
times more likely to have suicidal thoughts or episodes of self-harm
compared with those taking a placebo.
The rate of suicidal behavior among those taking Paxil was lower
than the normal rate of such behavior among depressed children who
got no treatment at all, Dr. Metz said. This is true because
treatment — even with dummy pills — can be highly effective against
None of the children in the studies succeeded in committing
Paxil is GlaxoSmithKline's largest-selling drug. The company is
in the midst of a legal fight to retain its exclusive hold over
Paxil's selling rights in the United States.