British Regulatory Agency Echoes US FDA Warning about SSRI Use in Young People

By Ellen Kuwana Neuroscience for Kids Staff Writer December 24, 2003 Tis the season to be jolly -- but if you're not, and you're under the age of 18, be aware that new research indicates that some antidepressants may cause more harm than good. The research suggests that, in patients under 18 years, many antidepressants seem to not help or increase the rate of self-harm or suicidal thoughts. After analyzing data from the various drug companies that manufacture antidepressants called selective serotonin reuptake inhibitors (SSRIs), the Medicines and Healthcare Products Regulatory Agency (MHRA) cautioned against the use of many SSRIs in young patients with major depressive disorder. This recommendation by British government officials echoed a similar health advisory issued by the US Food and Drug Administration in October of 2003. The MHRA looked at studies that investigated the use of SSRIs in people under the age of 18, to try to figure out if the benefits (helping lessen the symptoms of depression) of these drugs outweighed the risks and side effects (worsening hostility, suicidal thoughts, nausea, etc.). If the benefits of a particular SSRI outweighed its risks, then the MHRA recommended that SSRI for use in the under 18 patient population. At this time, only fluoxetine (Prozac) is recommended for this age group. In addition to SSRIs, treatment options for depression in young people include cognitive behavioral therapy or an antidepressant that is not an SSRI. This cautionary advice does not apply to adults. Why might medications approved for adults not work for children? Adults and children metabolize drugs differently, and children may have a "paradoxical" reaction to a drug, meaning the opposite of the desired effect. For example, a sedative given to a child might actually cause the child to become agitated. This recommendation has set off a debate about whether this step is too restrictive. Critics say that conclusions should not be drawn from these studies, which were conducted by different researchers at companies in different places, using different patient populations, different methods, and different ways of measuring depressive symptoms or side effects. Until more studies are completed, however, the UK and US are united in cautioning against the use of most SSRIs in young patients. Furthermore, young patients on SSRIs should be monitored by a specialist, or have their doctor consult a specialist before deciding on an SSRI. Patients who are already taking an SSRI should not stop medication without approval from a medical doctor. Drug Brand Name (US) Brand Name (UK) Recommended for 18 and younger? Fluoxetine Prozac Prozac Yes Sertraline* Zoloft Lustral No Citalopram Celexa Cipramil No Escitalopram Lexapro Cipralex No Data^ Fluvoxamine* Luvox Faverin No Research Available Paroxetine Paxil Seroxat No Venlafaxine Effexor Efexor ER No *The use of Sertraline and Fluvoxamine is not restricted in the under 18 population for treatment of obsessive-compulsive disorder (OCD). ^The risk/benefit balance is presumed unfavorable (no completed controlled clinical trials yet) because this drug is similar to Citalopram, and manufactured by the same company.