- Why is FDA recommending that Paxil not be used for
the treatment of pediatric major depressive disorder (MDD)?
FDA is currently reviewing reports of an increased risk of suicidal
thinking and suicide attempts related to the use of the drug Paxil in
children and adolescents under the age of 18 with MDD. Although FDA has
not completed this evaluation, we are recommending that Paxil not be
used in the treatment of pediatric MDD. There is no evidence that Paxil
is effective in children or adolescents with MDD.
- Should children using Paxil stop taking it
immediately?
It is very important that children and adolescents not
stop taking Paxil suddenly, as there is a risk of discontinuation
effects. Caretakers of children and adolescents currently taking Paxil
should consult their doctor to discuss the best course of action. If
they are doing well on Paxil, their doctor may advise that they complete
their course of treatment. If their doctor advises that Paxil should be
stopped, this should be done gradually to minimize the risk of
discontinuation effects. If the dose is not reduced gradually, there is
a greater chance of experiencing side effects. If severe unwanted side
effects occur, it may be necessary to start taking Paxil again or
increase the dose before subsequently decreasing the dose more
gradually.
- What data is the advice based on?
Three well-controlled clinical trials carried out in children (under
18 years of age) with MDD compared the effect of Paxil and placebo
(sugar pills) and found that Paxil did not work any better than placebo
in the treatment of MDD.
Based on the results of the new analyses of safety data from
pediatric studies, it was found that certain possibly suicide-related
behaviors, including suicidal thoughts and attempts, were more common in
children receiving Paxil. The risk of these events in the study was
about 3 times greater with Paxil compared to placebo. There were no
deaths in these trials.
- Is Paxil approved for the treatment of children and
adolescents?
The FDA has not approved Paxil for the treatment of MDD or any other
indication in pediatric patients. However, the FDA does not regulate the
practice of medicine and physicians may use a drug in ways other than
indicated on the labeling when, in their professional judgment, it is
warranted in a particular case.
- My child is taking Paxil for a condition other than
depression. What should I do?
Paxil has not been approved for use in children under the age
of 18 for any indication, but your child may have been prescribed Paxil
for an off-label use. As stated above, physicians may use a drug in ways
other than indicated on the labeling when, in their professional
judgment, it is warranted in a particular case. If your child is taking
Paxil, you should consult with your doctor before making any changes. It
is very important that Paxil not be stopped abruptly since
discontinuation effects may occur.
- What does this mean for the use of Paxil in adults?
Paxil is approved for use in adults for the following indications:
major depressive disorder, obsessive compulsive disorder, panic
disorder, social anxiety disorder, generalized anxiety disorder, and
post-traumatic stress disorder. Extensive analyses of the data from
studies of Paxil in adults and from postmarketing adverse event reports
have not revealed an increase in the rate of suicidal thoughts or
suicide attempts compared to placebo.
- What advice can you provide to adults using Paxil?
It is vital that patients are not panicked into stopping their
medication suddenly. The advice to adults using Paxil has not changed.
Paxil has been demonstrated to be effective in treatment of major
depressive disorder, obsessive compulsive disorder, panic disorder,
social anxiety disorder, generalized anxiety disorder, and
post-traumatic stress disorder in adults. Anyone taking Paxil who is
feeling unwell or is concerned about the treatment should consult his
or her doctor.
- Why would Paxil cause these reactions in children and
not in adults?
Childhood depression is different from adult depression. The
reasons are not clear but could relate to the continuing development of
the child’s brain. It has been difficult to show effectiveness in
children of antidepressants known to work in adults and a number of
effective adult antidepressants have not been shown to work in
childhood depression Children may also react very differently to
some medicines and some side effects over a range of drugs are seen in
children that are not seen in adults.
However, the Agency has not yet definitively determined that there is
an increased risk of suicidal behavior in pediatric patients with MDD
treated with Paxil.
- Are there drugs approved for the treatment of
depression in children?
Prozac (fluoxetine) is the only drug approved for the treatment of
major depressive disorder in children. It is approved in children 8 to
18 years of age.
- What is Paxil?
Paxil (paroxetine) is one of a class of medicines called Selective
Serotonin Reuptake Inhibitors (SSRIs). These drugs increase the activity
of an important brain chemical called serotonin, a chemical know to be
deficient in patients with MDD.
- How long has Paxil been on the market?
Paxil was first approved in the United States on December 29, 1992,
for the treatment of depression.
