British drug regulators warned doctors against prescribing GlaxoSmithKline’s antidepressant Paxil to children, after new research released by an independent group of scientists showed an increase in the risk of suicide or suicidal thinking among younger patients when Paxil was prescribed.
“There is an increase in the rate of self-harm and potentially suicidal behavior in this age group, when Seroxat (Paxil) 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.”
The British warning has prompted the Food and Drug Administration to launch its own investigation into the safety of Paxil for children.
“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.”
In the United States and Britain Paxil is not approved for use among children.
(via Washington Post)
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