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Due to the complexity of this drug and how it works, patients are routinely monitored for side effects and adverse reactions.
They may also depend on the type of patient (age, weight, sex, ethnicity, etc.) and can range in severity from very minor or common side-effects to more severe or major events that can be life-threatening and require immediate medical attention. Taking Paxil as prescribed is important to reduce these risks.
Common Side Effects of Paxil
People taking Paxil for Major Depressive Disorder and other indications may experience the following side effects:
- feeling anxious or trouble sleeping
- sexual problems
- not feeling hungry
- dry mouth
Paxil Boxed Warning and Label Updates
In October of 2004, the Food and Drug Administration (FDA) asked manufacturers of certain antidepressant drugs to include in their labeling a “boxed” warning statement that recommends close observation of adult and pediatric patients treated with these agents for worsening depression or thoughts of suicide.
Paxil (paroxetine) was included in this warning and the labeling was subsequently changed to reflect this. 1
SSRIs and Pregnancy Dangers
December 12, 2011- FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies 2
In a safety announcement, the FDA updated the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN). The initial advisory in July of 2006 was based on one study. The FDA had since seen conflicting results making it unclear of the potential risks to using SSRIs during pregnancy given that these drugs are commonly used to treat depression during this time.
Patients were advised to consult their healthcare professionals and to talk about the risks and benefits of treatment while the prescribers should refer to the guidelines for managing depression during pregnancy.
U.S. Food and Drug Administration, Postmarket Drug Safety Information for Patients and Providers, Worsening Depression and Suicidality in Patients Being Treated With Antidepressants, Rev. Aug 7, 2009. Accessed on July 30, 2013 ↩
U.S. Food and Drug Administration, Drug Safety and Availability, FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies, Rev. Aug 7, 2009. Accessed on July 30, 2013 ↩