The health ministry has learned that a widely prescribed antidepressant drug raises the risk of suicide by seriously depressed children at puberty, ministry and industry officials said Monday.
The Health, Labor and Welfare Ministry has ordered the importer to put warnings in its packages against administration of the drug to seriously depressed people aged under 18, the officials said. However, it also warns that a sudden halt in use of the drug could cause perception disorders and is calling instead for a gradual reduction.
The drug, imported and sold by GlaxoSmithKline KK, the Japanese subsidiary of GlaxoSmithKline PLC of Britain, carries the product name Paxil and is prescribed by doctors in Japan often as the first choice for treating depression.
However, the drug company’s clinical tests on children aged between 7 and 18 have found that the risk of patients with serious depression considering or planning suicide almost doubles when dosed with the drug, according to GlaxoSmithKline officials.
The tests, which covered more than 1,000 children in Britain, also failed to confirm that the drug had a remedial effect on the depression of the patients, they said.
Of 378 young patients who were prescribed the drug, 5.3% began to consider or plan suicide, compared with only 2.8% of 285 patients dosed with placebos.
Paxil is one of a new type of antidepressant called selective serotonin reuptake inhibitors, which are touted as having relatively few side-effects.
The ministry approved the product in 2000 for use in people aged 15 or older and the drug has since been given to 470,000 people a year, including some under 15 at some hospitals, the officials said.