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Since introduced in the late 1980s with Prozac, Selective Serotonin Reuptake Inhibitors, or SSRIs, have come under fire for several side effects, particularly birth defects when given to pregnant women and increased risks of suicidal behavior.

Paxil, generically known as paroxetine hydrochloride, falls into a similar pattern. SmithKline Beecham introduced it in 1992, and at the time, it became the third SSRI in the U.S. for treating depression. Over the years, doctors have prescribed it for panic disorders, obsessive-compulsive disorder, post-traumatic stress disorder, and general anxiety disorder.

Side Effects

Paxil has its own unique group of side effects and shares a few commonalities with other antidepressants. For one, several dangerous side effects stem from withdrawal symptoms, and two, potential birth defects increase when women take Paxil during the first trimester of pregnancy.

For the former, Paxil is associated with akathisia, a condition associated with suicidal tendencies, dysphoria, and aggression.

Studies have found, as well, that pregnant women taking this SSRI are 1.5 times more likely to have a child with heart defects, including:

  • A hole in the atrial and ventral septum
  • Persistent pulmonary hypertension of the newborn (PPHN)
  • Omphalocele
  • Hydrocephalus
  • Craniosynostosis

Along with these two risks, Paxil has been shown to negatively affect male fertility by damaging sperm through DNA fragmentation. Research has found a five-fold increase of abnormal sperm DNA for men taking this SSRI.

Additionally, stomach bleeding has occurred when Paxil reacts with aspirin.

Warnings

In October 2003, the FDA put out a notification concerning the occurrence of suicidal tendencies, including both ideation and attempts, in clinical trials for pediatric patients with major depressive disorder.

By March 2004, the FDA put out a Public Health Advisory as a warning to physicians, patients, and families, informing them that any adult or child with depression must be closely monitored when on Paxil, especially toward the beginning of treatment and at any time the dosage changes.

Following this, the FDA issued a third warning in December 2005 about increased risk of birth defects, particularly on a child’s heart. The statement further detailed that children exposed to Paxil in the womb may arrive premature or may not be getting enough oxygen in the blood. As a result, the FDA requested GlaxoSmithKline to change the drug from Category C to D, which indicates it’s the second-highest for birth defect risks.

Lawsuits

So far, lawsuits have focused on Paxil’s potential for birth defects, with GlaxoSmithKline settling about 800 cases for $1 billion as of 2010.

In these cases, plaintiffs allege the drug manufacturer had not provided sufficient warning about associated heart defects. Compensation has covered pain and suffering and current and future medical costs, as children born with birth defects often need multiple corrective surgeries through adulthood.

Yet, even with multiple FDA warnings, Paxil has grown to be one of the world’s most popular antidepressants. For the millions taking this SSRI, the instances suicidal tendencies and harmful withdrawal symptoms loom overhead, threatening a patient’s health and safety.

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