Antidepressant Paxil® Linked to Birth Defects
WASHINGTON, DC — October 14, 2005 — Pregnant women who take the antidepressant Paxil® may be at risk for delivering babies with birth defects, according to the Food and Drug Administration (FDA). The agency has asked Paxil®’s manufacturer, GlaxoSmithKline, to revise the drug’s prescribing instructions to include a new warning about the drug.
A study involved 3,581 pregnant women exposed to Paxil® or other antidepressants during their first trimester. The babies of Paxil® users were more likely to be born with birth defects, especially heart problems, compared to the babies of women who took other antidepressants. The most common fetal heart problem was a “ventricular septal defect,” which is a hole between the two ventricles or pumping chambers of the heart.
The new Paxil® labels describe the study and other clinical trials with the drug (see Paxil® and Paxil® Controlled–Release Tablets). Doctors are advised to carefully weigh the risks and benefits of Paxil® before prescribing it to pregnant women (Letter from GlaxoSmithKline, September 2005).
How Paxil® Works
Also known as paroxetine, Paxil® belongs to a class of medicines known as selective serotonin reuptake inhibitors (SSRIs). They adjust the amount of serotonin, a brain chemical that affects mood and transmits messages between nerve cells.
The FDA has approved Paxil® to treat serious depression or “major depressive disorder.” It is also used to treat panic disorder (attacks of fear and inability to function), social anxiety disorder (extreme fear of being with others), and obsessive compulsive disorder (repeated and unwanted thoughts and rituals).
Other Paxil® Side Effects
Paxil® has other serious side effects besides increasing the risk of birth defects. Children and teenagers who take Paxil® may become more depressed, according to some studies. The FDA states that one out of every 50 children or adolescents who take antidepressants such as Paxil® may think about suicide, talk about it, or go through with the act (Patient Information Sheet, July 8, 2005).
Other Paxil® side effects include seizures, dry mouth, sleep disturbances, tremors, and decreased appetite. Paxil® may also cause bleeding, especially if it is taken with NSAIDs (nonsteroidal anti–inflammatory drugs, such as aspirin, ibuprofen or naproxen). If patients try to stop taking Paxil® suddenly instead of gradually decreasing their dosage, they may experience dizziness, electric shock sensations, abnormal dreams, agitation, anxiety, mood changes, and nervousness.
Your Paxil® Case
For more information about Paxil®, see the FDA Patient Information Sheet. If you or your child has been injured due to harmful Paxil® side effects, please feel free to contact us. We pledge to handle your case with compassion and expertise. We provide a free case review and can advise you of your legal options.