Paxil Associated with Birth Defects
As of January 2006, the U.S. Food & Drug Administration is advising of the risk of birth defects associated with the use of the antidepressant Paxil (paroxetine), which is manufactured by GlaxoSmithKline. When pregnant women take the drug during their first three months of pregnancy, the risk of birth defects, in particular heart defects, is increased.
The FDA is recommending that Paxil not be prescribed to women who are in their first three months of pregnancy or who may become pregnant unless there are no other viable options for treatment. Paxil was upgraded to a Category D drug for pregnant women, meaning studies in pregnant women had shown the drug poses a risk to the fetus.
Case Background
Paxil is an type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor) and is used to treat a variety of depressive disorders. It has been approved by the FDA for the treatment of major depressive disorder (depression), social anxiety disorder, panic disorder, and premenstrual dysphoric disorder.
Over 50 million people in the United States suffer from one of these disorders. Paxil is approved for use in adults 18 years of age and over. It may be used for long-term treatment of depression. Paxil is generally prescribed as Paxil CR, which are controlled-release tablets taken once a day.
Health Risks and Symptoms
Two studies have shown that women who took Paxil during their first three months of pregnancy were 1.5-2 times as likely to have a baby with heart defects as women who were taking other antidepressants or women in the general population. The particular types of heart defects reported were holes in the walls of the chambers of the heart, knows as atrial and ventricular septal defects.
Glaxo Smith Kline was forced to update the warning label in September 2005 based on the preliminary data from the studies to reflect the more severe risk to the fetus. Some of the defects may be minor and resolve themselves, but others may cause severe symptoms and require surgery to repair.
Do I Qualify for a Paxil Lawsuit?
If you or a member of your family has taken Paxil while pregnant, then you may qualify for a lawsuit claim. Thousands of people have already filed claims.
In America today there are thousands of mass lawsuits and billions of dollars in unclaimed monies available for victims. If you have been wronged by a major corporation, you may be entitled to compensation for treatments and pain and suffering.
If you believe you have been wronged, take action to protect your rights.
Fill out the form to the right or call 1.800.387.4262 if you need additional information or want to discuss a potential claim with an attorney. All inquiries are kept strictly confidential.
If the inquiry is accepted for further review, you will receive a prompt response (usually the same day or by the next business day). Local counsel may be used for this matter.
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