Q: What is Paxil?

A: Paxil (paroxetine) is an SSRI (Selective Serotonin Reuptake Inhibitor). SSRIs increase the activity of the brain chemical known as serotonin, which is a chemical found to be deficient in MDD (major depressive disorder) patients.

Q: When was Paxil introduced into the market?

A: On December 29, 1992, Paxil was approved for treating depression in U.S. Patients.

Q: Has the FDA approved the use of Paxil for treating adolescents and children?

A: No. Neither has the FDA approved the use of Paxil for treating pediatric patients with any other type of indication. The FDA, however, does not regulate the way medicine is practiced, and physicians are allowed to use their professional judgment to prescribe a drug to a patient in ways that are not listed on the drug's label.

Q: Should a child stop taking Paxil immediately?

A: You should have a physician evaluate your child or adolescent regarding whether or not they should stop taking Paxil. Generally, adolescents and children should not stop taking Paxil all of a sudden, because there are side effects that may arise with immediate discontinuation.

If the patient is responding well to Paxil, his or her physician may suggest the continued use of Paxil until the treatment is complete. A health care provider who thinks that use of Paxil should be terminated should recommend that this be done gradually to minimize the chances of experiencing any discontinuation side effects. If unwanted and intense side effects are experienced by the patient once they decrease or stop their dosage, a physician may recommend that the dose be increased, resumed, or decreased at a more gradual pace.

Q: What is the basis for these recommendations?

A: In three clinical trials, children 18 years of age and under were tested using sugar pills (placebos) and Paxil in treating MDD. In all three tests, results found that Paxil was not any more effective at treating MDD than the placebos.

Pediatric studies also have shown that suicide-related behaviors and thoughts commonly occurred in children taking Paxil. The risk of attempted suicide or suicidal thoughts was three times higher in children using Paxil. No one, however, died during these trials.

Q: If my child is using Paxil for a different condition, what do you advise that I do?

A: Although the FDA has not approved the use of Paxil by children for any kind of treatment, a physician may have exercised their professional judgment by prescribing Paxil for use in a way that was not indicated on its drug label. You should speak to the doctor and discuss your options. Remember that a person should not stop using Paxil completely because of the side effects that can occur. Gradual discontinuation is recommended.

Q: What drugs are available to treat children with depression?

A: The only drug FDA approved to treat children ages 8-18 who are experiencing major depressive disorder is Prozac (fluoxetine).

Q: Why does Paxil cause some children, but not adults, to experience suicidal tendencies?

A: It is unclear why this is the case, but one possibility is because a child's brain is still developing. Also, adult depression is very different from childhood depression. It has been difficult to find an antidepressant that works effectively in adults that also works well on children, and there have been a number of antidepressants that worked for adults but not for children. Children may also respond differently than adults to certain medications, and there have been side effects found to occur in children that did not show up in adults.

Q: How doe Paxil affect adults?

A: The FDA has approved the use of Paxil by adults for a number of indications, including:

• Social anxiety disorder.
• Major depressive disorder.
• Panic disorder.
• Post-traumatic stress disorder.
• Obsessive-compulsive disorder.
• General Anxiety disorder.

Information from adult Paxil studies and post-marketing reports comparing Paxil and placebos do not indicate any increase in suicidal behavior or thoughts among adult patients taking Paxil.

Q: What advice do you have for adult Paxil users?

A: As with children that use Paxil, it is important that adult patients do not completely stop taking this drug all of a sudden. Anyone--adolescent, adult, or child--who is not feeling well and is taking Paxil should talk to a doctor immediately.