Paxil Warning for Depressed Kids
Paxil Warning for Depressed Kids
British Officials Cite Increased Suicidal Thoughts, Attempts in Children Taking Paxil
June 11, 2003 -- British officials are warning doctors against prescribing the antidepressantPaxil for depression in children and teens. But U.S. officials at the FDA say they have not yet decided whether to issue a similar warning.
An advisory issued Tuesday by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) states that Paxil -- sold under the brand name Seroxat in Britain -- is associated with an increased risk of self-harm and suicidal behavior and thoughts in people under the age of 18.
"It has become clear that the benefits of [Paxil] in children for the treatment of depressive illness do not outweigh these risks," the MHRA statement reads. The warning does not apply to the use of Paxil in adults.
The decision was made after Paxil manufacturer GlaxoSmithKline submitted data involving more than 1,000 pediatric patients taking Paxil for depression. Investigators found that suicidal thoughts and attempts were roughly twice as high among children and adolescents taking Paxil than among those taking placebos (3.2% vs. 1.5%).
Although Paxil is not specifically approved by the FDA for use in children, it is commonly prescribed for this age group in the U.K. and the U.S. U.K. Department of Health spokeswoman Alison Langley tells WebMD that roughly 8,000 of the close to 4 million prescriptions for Paxil issued in the U.K. last year were for children under the age of 18.
In a statement issued Tuesday, GlaxoSmithKline officials noted that no actual suicides occurred among the children taking part in the studies and that the British warning is for depression and not other psychiatric conditions. The FDA is considering a petition from the company to approve the drug for the treatment of obsessive-compulsive disorder in children.
GlaxoSmithKline is a WebMD sponsor.
Paxil Warning for Depressed Kids
British Officials Cite Increased Suicidal Thoughts, Attempts in Children Taking Paxil
June 11, 2003 -- British officials are warning doctors against prescribing the antidepressantPaxil for depression in children and teens. But U.S. officials at the FDA say they have not yet decided whether to issue a similar warning.
An advisory issued Tuesday by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) states that Paxil -- sold under the brand name Seroxat in Britain -- is associated with an increased risk of self-harm and suicidal behavior and thoughts in people under the age of 18.
"It has become clear that the benefits of [Paxil] in children for the treatment of depressive illness do not outweigh these risks," the MHRA statement reads. The warning does not apply to the use of Paxil in adults.
Suicidal Thoughts, Attempts Double
The decision was made after Paxil manufacturer GlaxoSmithKline submitted data involving more than 1,000 pediatric patients taking Paxil for depression. Investigators found that suicidal thoughts and attempts were roughly twice as high among children and adolescents taking Paxil than among those taking placebos (3.2% vs. 1.5%).
Although Paxil is not specifically approved by the FDA for use in children, it is commonly prescribed for this age group in the U.K. and the U.S. U.K. Department of Health spokeswoman Alison Langley tells WebMD that roughly 8,000 of the close to 4 million prescriptions for Paxil issued in the U.K. last year were for children under the age of 18.
In a statement issued Tuesday, GlaxoSmithKline officials noted that no actual suicides occurred among the children taking part in the studies and that the British warning is for depression and not other psychiatric conditions. The FDA is considering a petition from the company to approve the drug for the treatment of obsessive-compulsive disorder in children.
GlaxoSmithKline is a WebMD sponsor.
