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. Paxil was first approved in the United States on December 29, 1992, for the treatment of depression. Paroxetine is available as Paxil, Paxil CR, Pexeva, and generic paroxetine hydrochloride. It is manufactured by GlaxoSmithKline, a large pharmaceutical company with reported earnings of $43.7 billion.
The Food and Drug Administration (FDA) has issued multiple Public Health Advisories regarding the risk of congenital malformations in babies born to mothers who take Paxil (and other similar SSRIs drugs) during pregnancy. In particular, the increased risk is associated with persistent pulmonary hypertension (PPHN) and cardiac malformations which are holes in the walls of the chambers of the heart. At the FDA’s request, the manufacturer has changed paroxetine’s pregnancy category from C to D (which indicates that “there is positive evidence of fetal risk) and added new data and recommendations to the Warnings section of paroxetine’s prescribing information.
The FDA is currently reviewing reports of an increased risk of suicidal thinking and suicide attempts related to the use of the Paxil in children and adolescents under the age of 18. Based on the results of the new analyses of safety data from pediatric studies, the FDA found that certain possibly suicide-related behaviors, including suicidal thoughts and attempts, were more common in children receiving Paxil.
The FDA issued a statement in which it stated: “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.”