FDA advisories. The U.S. Food and
Drug Administration (FDA) has issued advisories to patients, families, and
health professionals to closely monitor for warning signs of suicidal behavior
in children and adults younger than 25 who take antidepressants. This is
especially important at the beginning of treatment or when doses are changed.
The FDA also advises 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 behaviors in
children, who are less able to control their impulses and may be at greater
risk for suicidal behaviors.
Antidepressants are designed to
boost mood and relieve sadness, but for some patients, their side effects fuel
another emotion: frustration. Just ask Maryland resident Jane Niziol. Her
doctor prescribed Paxil after a difficult breakup left her feeling depressed
and overwhelmed. Niziol recalls the medicine calmed her mood. "Suddenly I
didn't care about anything."
Except that the drug started to affect her waistline. After just a few
months on Paxil, Niziol gained nearly 35 pounds. She...
The FDA has not recommended that
children and young adults stop using antidepressants. If you have concerns
about a child or young adult who is taking an antidepressant, talk to a doctor.
After reviewing 24 antidepressant trials involving over 4,400
children and teens, the FDA concluded that young people using antidepressants
are more likely to report having suicidal thoughts and behavior. On average, 4 out of
100 children who used an antidepressant reported having suicidal thoughts or behavior,
compared to 2 out of 100 who took a placebo. This means that 96 out of 100
children who used antidepressants did not report having suicidal thoughts or behavior.
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
A newer study found that
the benefit of taking antidepressants was greater than the risk of suicidal
thoughts and behavior in children and teens.2
The FDA has asked drug companies to include in their packaging inserts a
"black box" warning, the government's strongest medication warning. The
warning, appearing in bold letters inside a black box, recommends that anyone
considering the use of that drug (or any antidepressant) in a child or young
adult needs to carefully balance the risk of taking the drug with the need to
use it. It also recommends that family members and caregivers closely watch for
warning signs of suicide in a child or young adult taking an