Although antidepressants are very effective in relieving depression, some patients—especially young people—may temporarily feel worse when they first start taking antidepressants or change doses.
Black box warning
In October 2004, the US Federal Drug Administration (FDA) issued a so-called “black box” warning, stating that certain antidepressants, when used in young people aged 24 and below, may increase their suicidal thoughts and behavior. risk.
The FDA noted that in adults over 24, no association was found between antidepressant use and suicidal thoughts and behavior.
Antidepressants actually seem to reduce the risk of suicide in adults 65 years and older.
This boxed warning is the most serious type of warning that can be issued for prescription drugs. It was issued after a thorough review of all available clinical trials (including unpublished trials) involving the use of antidepressants in children and adolescents.
The study included a total of 24 short-term trials, using nine different antidepressants on more than 4,400 children and adolescents.In addition, there were 295 short-term trials of 11 different antidepressants, involving 77,000 adult patients.
Although suicide risk varies from drug to drug, the pattern of increased suicide rates among young people remains the same for almost all drugs studied.
It should be noted that there were actually no suicides among the young people studied. Although there were some suicides among the adults studied, the number was too small to draw any conclusions about whether the antidepressants used were a causal factor.
It is also important to remember that depression itself is also a known risk factor for suicide and cannot be ruled out in these cases.
The black box warning further indicates:
- In addition, family members and other caregivers should be instructed to contact the patient’s doctor or other appropriate medical professional if any problems arise.
- Patients of all ages should be closely monitored when starting antidepressant treatment.
- It should be noted whether they have any signs of worsening depression, increased suicidal tendencies, or behavior changes.
Effect of warning
The FDA’s decision is not without controversy. The FDA’s decision had unintended consequences, and the research itself was criticized due to methodological issues.Studies have shown that after the FDA decided to include a black box warning, the diagnosis of depression and the prescription rate of antidepressants have declined.
Another worrying trend is the increase in psychotropic drug poisoning. This may indicate an increase in suicide attempts, although it is unclear whether these poisonings were accidental or deliberate.
Some evidence suggests that the combination of FDA warnings and alarmist media reports may exaggerate the link between antidepressant use and suicide, which has played a role in reducing the use of effective drugs.
What to pay attention to
In particular, if you or the person you care for experience any of the following conditions, FDA recommends contacting a healthcare provider:
- Aggression, anger or violence
- Any other abnormal changes in mood or behavior
- Extremely increased activity or conversation (signs of mania)
- Feelings of excitement or restlessness
- New or worsening anxiety
- New or worsening depression
- New or worsening irritability
- Panic attack
- Sleep problems
- Attempted suicide
- Thoughts of suicide or death
Although the black box warning may be worrying for some people, they should be aware that in most cases, the benefits of using antidepressants to treat depression far outweigh the risks. Untreated depression is very serious and is more likely to lead to suicide than antidepressants.
The warning is provided only to make people aware of this potential impact and take appropriate measures to seek help when they start to feel worse.