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Abstract

This June, the UK government warned physicians in the UK against prescribing the anti‐depressant drug Paxil® (Seroxat®; GlaxoSmithKline, Uxbridge, UK) to children under 18. The Committee on the Safety of Medicines (CSM), the UK's regulatory body, reacted to several reports of suicides and suicidal thoughts by adolescents taking the drug to treat depression. Immediately after the CSM's warning, GlaxoSmithKline also sent letters to healthcare professionals in the UK to warn about both withdrawal symptoms and the suicide risk for children. These events triggered renewed concerns in the USA about the safety of using anti‐depressant drugs in children and adolescents. In July, the Connecticut Department of Children and Families (DCF) removed Paxil from the DCF Psychotropic Medication Formulary for six months and urged physicians to reassess the risks and benefits of the medication. New York Senator Charles E. Schumer sent a letter to Mark McClellan, Commissioner of the US Food and Drug Administration (FDA), asking him to investigate the adverse effects of the drug and to put a hold on GlaxoSmithKline's request to sell Paxil for children's use pending the outcome of the study. The FDA also began to review the side effects of Paxil and other anti‐depressants and stated in September that it found a threefold higher rate of suicidal ideation—suicide‐related thoughts—compared with a placebo. More recently, the CSM recommended on 19 September not to prescribe Wyeth‐Ayerst's (Madison, NJ, USA) anti‐depressant Effexor® to children under the age of 18. Indeed, the company had already sent warning letters to physicians in the USA before the CSM's warnings, stating that Effexor might cause suicidal thoughts in children. This flurry of investigations and warning letters and the resultant press coverage have provided new ammunition for critics who have sounded alarms over the use of anti‐depressant drugs in children and charged that they are …