The British government warned doctors yesterday against prescribing the
antidepressant Paxil to children, spurring the U.S. Food and Drug
Administration to confirm that it is conducting its own investigation into
the safety of the drug for younger patients.
The British warning said the medicine appeared to increase the risk of
suicide or suicidal thinking among children with depression.
The U.S. agency is examining the same studies that Paxil's manufacturer
submitted to British authorities.
"There is data that has come to light that may be noteworthy," said an
FDA official yesterday, speaking on the condition of anonymity. "We will
take whatever action is deemed appropriate to protect the public
The FDA official gave no timetable for a decision, but said, "when you
have a serious question like this, you want to do the analysis as quickly
The British warning was issued after an independent group of scientists
and regulators concluded that the risks of Paxil, which is marketed as
Seroxat in Britain, outweighed its benefits among children and adolescents
"There is an increase in the rate of self-harm and potentially suicidal
behavior in this age group, when Seroxat is used for depressive illness,"
said a statement from the Medicines and Healthcare products Regulatory
Agency. "It has become clear that the benefits of Seroxat in children for
the treatment of depressive illness do not outweigh these risks."
Paxil is one of a group of medicines called selective serotonin
reuptake inhibitors (SSRIs) used to treat depression, anxiety and other
psychiatric disorders. Charges that the drugs increase the risk of suicide
have dogged the medicines since the first SSRI, Prozac, was introduced in
the late 1980s.
Regulators and most psychiatrists have maintained that the medicines
are safe, even though some doctors have said the drugs have a dangerous
profile. Although many patients say they have benefited from the
medicines, others say they have been harmed, have launched large advocacy
campaigns against the drugs over the Internet and have filed lawsuits.
Paxil is not approved for use among children in the United States or
Britain, but doctors have written thousands of "off-label" prescriptions
for it. Off-label prescriptions are uses of FDA-approved drugs for
purposes other than those approved by the agency.
Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, the manufacturer of
Paxil, said that of about 28 million prescriptions for Paxil last year,
less than 10 percent, possibly less than 5 percent, were written for
Alan Metz, vice president for clinical development for the company,
said that British authorities had overreacted, drawing conclusions from
small statistical differences.
Metz said the company had submitted data to both British and U.S.
regulators supporting Paxil's safety and effectiveness among children and
adolescents. Nine studies compared Paxil with dummy pills among 1,200
children who suffered from depression, obsessive-compulsive disorder and
social anxiety disorder.
He said 33 children had shown signs of mood swings that included
suicidal thinking and suicide attempts. In that number, the rate was about
1 percent to 2 percent in the group taking placebos, and about 2 percent
to 3.5 percent in the group taking the medicine, he said.
In its warning yesterday, the British health agency said that children
taking Paxil should not discontinue treatment without medical supervision.
It added that "patients over 18 years and those who are benefiting from
Seroxat should not be frightened into stopping their medication."