One of the most commonly prescribed antidepressants for children and adolescents can double the risk of aggression and suicide, according to research published in The BMJ.
In the US, it is estimated that 1.2% of people under 18 years of age were taking prescription antidepressants in 2009-2012.
However, there have been reports of deaths, suicide and violence by people taking these drugs. In the US, the Food and Drug Administration (FDA) have warned of antidepressants leading to suicide among young adults aged 18-24 years.
The FDA recommend monitoring for all patients taking antidepressants to check for worsening of symptoms, suicidal tendencies and any unusual changes in behavior.
Poorly designed studies mask potential dangers
Previous studies of the risks have been poorly designed and findings have been misreported. As a result, it is not known exactly how serious the dangers relating to antidepressant use are for adults or children. Potential risks include aggression, suicidal tendencies and fatality.
A team of researchers from Denmark, concerned about the dearth of published evidence of harms associated with antidepressants, decided to analyze clinical study reports and summary trial reports to gain more information.
The team procured clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline and venlafaxine from British and European regulatory agencies. Summary trial reports for duloxetine and fluoxetine were accessed through the website of the drug company Eli Lilly.
The researchers systematically reviewed 68 clinical study reports of 70 trials involving 18,526 patients to learn more about the risks, which include deaths, suicidal ideation, suicide attempts and aggression. They also looked at akathisia, a type of restlessness that can contribute to violence and suicide.
The trials that were selected featured patient narratives or lists of harms experienced by individual patients.
Previous studies failed to report adverse effects of antidepressant use
In adults, antidepressants did not appear to be linked to suicide and aggression.
In children, however, the risk of suicide and aggression was doubled. Results also showed that previous trials had failed to report adverse effects and were marred by design faults. Comparisons between clinical study results and data from listings or patient narratives showed that deaths and suicide had been wrongly classified for people using antidepressants.
One pharmaceutical company misreported four deaths in favor of the antidepressant, and over 50% of suicidal incidents were put down to "emotional lability" or "worsening of depression."
- Millions of children in the US live with disorders such as depression, ADHD and Tourette's syndrome
- ADHD is the most common problem among those aged 3-17 years
- Adolescent girls are most likely to suffer from depression and alcohol-related disorders.
Eli Lilly recorded most of the deaths that occurred, but they failed to note 90% of the attempted suicides. Information on other outcomes was lacking.
The authors describe these results as "even more unreliable than we previously suspected."
They explain that it is difficult to assess the true risk of serious incidences arising from antidepressant use because events are relatively rare, and poor design and reporting of the trials makes accurate estimations difficult.
The researchers suggest treating depression in children with exercise or psychotherapy, where possible. They also they call for "hidden information" from trial reports to be identified to create a more accurate reflection of the good and bad effects of drugs.
One limitation of the study is that reports and listings were not available for all trials and all antidepressants.
Joanna Moncrieff, from University College London (UCL) in the UK, writes in an accompanying editorial that "regulators and the public need access to more comprehensive and reliable data."
She adds that clinical study reports "are likely to underestimate the extent of drug-related harms."
She also wonders how many other adverse events have not been revealed and expresses concern that this kind of information is not revealed.
Recommendations from the research team include:
"Minimal use of antidepressants in children, adolescents and young adults, as the serious harms seem to be greater, and as their effect seems to be below what is clinically relevant."
Medical News Today recently reported on a study suggesting antidepressants may increase risks of bipolar disorder and mania.