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.
Paxil® and Birth Defects
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) cardiac malformations such as atrial and ventricular septal defects, 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.
In a study using Swedish national registry data, women who received paroxetine in early pregnancy had an approximately 2-fold increased risk for having an infant with a cardiac defect compared to the entire national registry population (the risk of a cardiac defect was about 2% in paroxetine-exposed infants vs. 1% among all registry infants). In a separate study using a United States insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall compared to infants of women who received other antidepressants in the first trimester. The risk of a cardiac defect was about 1.5% in paroxetine-exposed infants vs. 1% among infants exposed to other antidepressants. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common type of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own. It is of note that the data in these studies was limited to first trimester exposures only.
Another study suggests there may be additional, though rare, risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug compared to another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.
Paxil® and Adolescent Suicide
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 with MDD. Although the FDA has not completed this evaluation, it has recommended that Paxil not be used in the treatment of pediatric MDD because there is no evidence that Paxil is effective in children or adolescents with MDD. Three controlled clinical trials carried out in children under 18 years of age with MDD compared the effect of Paxil and placebo (sugar pills) and found that Paxil did not work any better than placebo in the treatment of MDD.
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 risk of these events in the study was about 3 times greater with Paxil compared to placebo. The FDA has not approved Paxil for the treatment of MDD or any other indication in pediatric patients. However, the FDA does not regulate the practice of medicine and physicians may use a drug in ways other than indicated on the labeling when, in their professional judgment, it is warranted in a particular case.
Consult A Doctor On Medical Issues
The Steinberg law firm does not intend, by this web site or otherwise, to dissuade anyone from taking medication without their doctors' approval. Please consult your doctor, not your lawyer, on matters relating to your health. It could be dangerous to stop taking medicines, especially abruptly. Patients should talk to their physicians to decide whether the benefits and risks of taking Paxil make it the right choice for them.
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."
Consult A Lawyer on Legal Issues
Please call or e-mail us for a free legal consultation if you or a loved one took Paxil and suffered side effects. You will not be charged any fee for the consultation and, if we take your case, you will not be charged a fee unless we win your case.
Please e-mail Andrew E. Steinberg* at: email@example.com for a free, confidential consultation, or call us at 713-529-0025.
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