Paxil FAQ
Q: What is Paxil?
A: Paxil (paroxetine hydrochloride) is in a class of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). Paxil tablets and oral suspension are used to treat depression, panic disorder, social anxiety disorder (SAD), obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and generalized anxiety disorder (GAD).
Paxil is made by GlaxoSmithKline and was approved by the U.S. Food and Drug Administration (FDA) in 1992.
Q: What is Paxil CR?
A: Paxil CR (controlled-release tablets) is a different formulation of Paxil. Paxil CR is used to treat depression, panic disorder, social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD).
Q: Has there been any recent news about Paxil?
A: Over the last few years, the FDA has worked closely with manufacturers of all marketed antidepressants (including Paxil) to fully evaluate the risk of suicidality in children, adolescents, and adults treated with these medications. Paxil maker GlaxoSmithKline added a black box warning to Paxil prescribing information describing the increased risk of suicidal thoughts and behavior in children and adolescents taking antidepressants. Click here for more information.
More recently, in May 2006 GlaxoSmithKline and the FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the "WARNINGS" section of prescribing information for Paxil and Paxil CR. These labeling changes relate to adult patients, particular those who are younger adults.
In July 2006, the FDA issued two alerts related to Paxil. The first FDA alert announced the results of a study concerning the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN). Click here for more information on this FDA alert.
The second FDA alert states that a life-threatening condition called serotonin syndrome can occur when SSRIs (such as Paxil) and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are taken together. Click here for more information on this FDA alert.
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Most content above from the U.S. Food and Drug Administration
