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 health.”
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 as possible.”
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 with depression.
“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 children.
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.”