Paxil Dangerous for Teens, Previous Study Flawed

In 2001, the publication of Study 329 prompted a 36 percent increase in prescriptions for Paxil (paroxetine), as it led healthcare providers to believe that Paxil was safe for use in adolescents. Yet, a reassessment of the same clinical data questions the accuracy of the original study and has concluded that the drug is not necessarily safe for young people and does not necessarily provide a measurable benefit. The re-analysis was published in the September 17, 2015 issue of The BMJ (formerly the British Medical Journal).

About Paxil

Paxil is an antidepressant. It is classified as a selective serotonin reuptake inhibitor (SSRI), which is believed to work by affecting the balance of certain chemicals in the brain. Paxil may be prescribed to treat patients who have been diagnosed with depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Antidepressants such as Paxil are associated with a possible increased risk of suicidal thoughts and actions when the drugs are used by young patients. Other serious side effects of Paxil may include hallucinations, agitation, mania, hypomania, and serotonin syndrome.

Paxil study questioned

The now-infamous Study 329 has long been a source of controversy among clinicians. The trial was funded by the makers of Paxil, GlaxoSmithKline. It involved 275 children between the ages of 12 and 18, all of whom were diagnosed with major depression. The study participants were divided into three groups. One group received Paxil, another received Tofranil (imipramine) – which is another type of antidepressant – and the third group received a placebo pill.

Dr. Martin Keller of Brown University, who led Study 329, monitored depression scores among the study participants over eight weeks. On a standard depression questionnaire, the group of kids taking Paxil did not show an improvement as compared to the other groups. However, the Paxil group did rate more favorably on secondary measures. Clinicians typically perceive secondary measures as being the medical equivalent of circumstantial evidence.

Re-analysis of Study 329

Study 329 was published in the Journal of the American Academy of Child and Adolescent Psychiatry. However, many researchers began criticizing the study shortly after it was published, claiming that the report understated the risks of Paxil and overstated its potential benefits. Until recently, GlaxoSmithKline had not made the raw data from Study 329 available to independent researchers. When the data were made available, the researchers who conducted the re-analysis came to the polar opposite conclusion as the original researchers.

The researchers who collaborated on the new report claimed that the results were misleading because of the way in which the original researchers evaluated the data. For instance, the original researchers allegedly downplayed the incidences of suicidal ideas and self-injurious actions. The new researchers claimed that some of these incidences were misclassified as “emotional lability,” which refers to unexpected laughter or crying.

The new report also suggests that the trial researchers did not take into consideration data that revealed potential harmful effects of Paxil because they considered the differences between Paxil and the placebo outcomes to be not statistically significant.

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