Reported Adverse Drug Reaction Cases
Paroxetine not safe for children, an increase in the rate of self-harm and potentially suicidal behaviours reported
LONDON (Reuters) - British drug regulators warned on Tuesday that GlaxoSmithKline's controversial top-selling antidepressant Seroxat (paroxetine) should not be used to treat depression in people under 18.
The Medicines and Healthcare products Regulatory Authority (MHRA) said new data received in the last two weeks showed an increase in the rate of self-harm and potentially suicidal behaviours in this age group when Seroxat was prescribed.
"It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks," the MHRA said in a statement.
Seroxat, known as Paxil in the United States, belongs to the same class of SSRIs (selective serotonin reuptake inhibitors) as Eli Lilly & Co.'s Prozac (fluoxetine). It generated global sales of £2.06 billion ($3.40 billion) in 2002, of which some £100 million was sold in Britain.But the medicine -- one of the world's best-selling pharmaceuticals -- has been the subject of increased public concern recently following reports of adverse reactions, including suicidal thoughts and withdrawal symptoms.
In India paroxetine is available as Panex (Syncro) 10, 20 mg Tablets, Parotin (Protec) 10 to 40 mg Tablets and Xet ( Zydus Neurosciences) 10 to 40 mg Tablets. Although the drug is not officially approved for use among under-18s, doctors have had discretion to prescribe it to young people on a so-called "off-label" basis. A total of four million prescriptions were written for Seroxat in Britain last year, with around 8,000 patients under 18 receiving treatment. The British government set up an expert group on SSRIs following mounting reports of side effect issues with Seroxat. New data from various clinical trials showed episodes of self-harm and potentially suicidal behaviour were between 1.5 and 3.2 times higher in under-18s taking Seroxat than in those receiving a placebo, or dummy, pill, the MHRA said.