The FDA urged drugmakers to put new warning labels on popular antidepressant medications. Alerting to watch for suicidal tendencies, hostility and agitation in patients taking the drugs.
FDA focuses on Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron and follows a warning by the British government last year advising physicians not to prescribe most widely used antidepressants to children.
FDA said it does not know whether the medications are responsible for reported side effects such as inner restlessness, agitation and suicidal thoughts in some people. Officials said they are drawing greater attention to known cautionary information while a team of outside researchers completes a comprehensive analysis of the possible risks.
Critics of the medications demanded that the FDA go further. Although Prozac is the only one of this class of drugs that has been specifically approved to treat depression in children, doctors are writing tens of thousands of prescriptions for many of the others, based on their clinical judgment that the drugs are safe and effective.
Many critics complain that a majority of studies of the drugs in children found that the medications did no better than dummy pills in treating depression, but that these studies have been hidden from doctors and the public. The companies say the studies are proprietary.
Many psychiatrists say the medications save lives and warn that discouraging patients from taking them could lead to greater numbers of suicides. They insist that suicidal tendencies or attempts among patients taking the drugs are the result of underlying disorders, not the medications.
The Public Health Advisory containing the new label warnings and cautions is available online at http://lifeinpain.org/le
The use of antidepressant medications among children and adolescents in the USA continues to grow at about 10% annually, say investigators who note that the fastest growth was seen among pre-school children younger than 5 years.
The study, carried out by the pharmacy benefit management company Express Scripts, examined antidepressant use in approximately 2 million children and adolescents aged 18 years or younger for the years 1998, 1999, 2000, 2001, and 2002.
The overall prevalence of antidepressant use among children increased from 1.6% in 1998 to 2.4% in 2002, reflecting an annual increase of 9.2%.
The growth in use was greater among girls than among boys, at 68% and 34%, respectively. For each gender separately, growth was highest among young boys and older girls.
Fastest growing segment of users was found to be children aged below 5 years, with use among these children doubling between 1998 and 2002 for girls and increasing by 64% for boys.
Over the 5-year period, selective serotonin reuptake inhibitors were the most commonly dispensed antidepressants, while tetracyclics were those least prescribed. This is despite the fact that fluoxetine is the only antidepressant that has received FDA approval for the treatment of depression in children and adolescents, the researchers note.