Researchers are warning medical professionals, and parents and guardians of teens that Paxil may make the teens suicidal, or more likely to do physical harm to themselves.

The 2001 Study on Teens

Originally in 2001, a clinical study was performed that came to the conclusion that the drug paroxetine, the active ingredient in Paxil, was safe to be given to teens. Doctor John Nardo is a psychiatrist at the Emory University Psychoanalytic Institute in Atlanta, Georgia. Doctor Nardo and a team of research specialist looked at the data that was used to reach the conclusion that paroxetine was safe to administer to teens and came to a completely different conclusion.

After examining the data Dr. Nardo concluded that Paxil, and all medications containing paroxetine are unsafe, and possibly harmful, for teens.

Why look at the old study a second time?

Doctor Nardo explains that an international group of researchers launch a campaign to re-examine some old clinical trials and see if the original findings still stand firm according to the original data. This group is dedicated to restoring invisible and abandoned trials and they call their operation RIAT.

The Paxil study has been controversial since it was performed in 2001. The original study was conducted and controlled by the manufacturers of the drug. That meant that a biased opinion on the safety of the medication was more likely than if the drug testing had been done by outside parties. RIAT examined the data and concluded that the findings were biased. The drug was never safe for teens to use.

According to the 2001 study 329 participants that were in their teens did well while taking the medication. Many people in the medical community were skeptical of these reports, and in 2003 the Food and Drug Administration made the manufacturers of Paxil, and several other drugs issue a black box warning on the medications.

Black Box Warning

A black box warning is the most severe of warnings about the possible side effects of a medication. All of the medications that were mandated to issue the black box warnings along with Paxil were selective serotonin reuptake inhibitors.

The warning that was issued declared that the medications could cause children and teens to have suicidal thoughts and tendencies while taking the medication.

The effectiveness of Paxil

Once the data that had originally been collected for the approval trials was re-evaluated it became clear that Paxil is not an effective medication for teens with depression. When given Paxil and a placebo during the trials the children who took the Paxil did not show any marked improvement over the children who were taking the placebo.

This leads researchers to believe that not only is Paxil possibly harmful to the teens, but it was never proven to be effective for the purpose it was being prescribed for.

What this means

Medical professionals working with teens and children suffering from depression and similar mental disorders should not consider Paxil as part of the treatment plan.