Health Canada and FDA advisories for antidepressants
Health Canada and FDA Advisories. Health Canada and the U.S. Food and Drug Administration (FDA) have issued advisories to patients, families, and health professionals to closely monitor for warning signs of suicidal behaviour in children and adults younger than 25 taking antidepressants. This is especially important at the beginning of treatment or when doses are changed.
Health Canada and the FDA also advise patients to watch for an increase in anxiety, panic attacks, agitation, irritability, insomnia, impulsivity, hostility, and mania. It is most important to watch for these behaviours in children, who are less able to control their impulsivity and may be at greater risk for suicidal impulses.
Health Canada and the FDA have not recommended that people stop using antidepressants but simply to monitor those taking the medications and, if concerns arise, to contact a health professional.
After reviewing 24 antidepressant trials involving over 4,400 children and teens, Health Canada and the FDA concluded that young people using antidepressants are more likely to have suicidal thoughts and behaviour. On average, 4 out of 100 children who used an antidepressant had suicidal thoughts or behaviour, compared to 2 out of 100 who took a placebo. This means that 96 out of 100 children who used antidepressants did not have suicidal thoughts or behaviour. The highest risk was during the first few months of treatment. The study found no increase in completed suicides, and no suicides occurred in any of the trials studied.1
A newer study found that the benefit of taking antidepressants was greater than the risk of suicidal thoughts and behaviour in children and teens.2
Health Canada and the FDA have asked drug companies to include in their packaging inserts a "black box" warning, the government's strongest medication warning. The warning, appearing in bold lettering inside a black box, recommends that anyone considering the use of that drug (or any antidepressant) in a child or teen needs to carefully balance the risk of prescribing the drug with the need to use it. It also recommends that family members and caregivers closely monitor a child or teen taking an antidepressant for warning signs of suicide.
The black box warning notes the drug's approved uses. Currently the only drug approved to treat depression in children is fluoxetine (Prozac), although other antidepressants are commonly used. Health professionals often prescribe medicines that are not specifically approved but may still be safe and effective. This is called unlabelled use.
Although suicidal thoughts and behaviour are a risk for children and teens taking an antidepressant, Health Canada and the FDA recognize that for many young people, the benefits of antidepressant treatment with proper precautions may outweigh the risks. Left untreated, depression can cause a number of long-term consequences, including suicidal behaviour. For some young people, taking an antidepressant can alleviate the symptoms of depression and their negative consequences and may actually reduce the risk of suicide in the long run.
If your child is currently taking an antidepressant, watch carefully for danger signs, especially during the first few weeks of treatment. If you are concerned about Health Canada and FDA warnings or about warning signs of suicide, contact your child's health professional.
Your teen or child should never stop taking antidepressants suddenly. Antidepressant use should be tapered off slowly and only under the supervision of a health professional. Abruptly stopping antidepressant medicines can cause withdrawal symptoms or a relapse into another depressive episode.
| Author: | Jeannette Curtis Lila Havens Carrie Henley | Last Updated: June 26, 2007 |
| Medical Review: | Anne C. Poinier, MD - Internal Medicine Michael J. Sexton, MD - Pediatrics Gisele Ferguson, MD, FRCPC - Psychiatry, Child and Youth Psychiatry | |
 | ||
| |