Infant Heart Defect Lawsuits, Paxil Heart Defect Lawsuits, Paxil Heart Birth Injury Lawsuits, Paxil Infant Heart Valve Lawsuits, Seroxat Infant Development Lawsuits, & Paxil Heart Defect Lawsuits by Texas Infant Heart Defect Lawyer Jason S. Coomer
Mothers that have taken Paxil while pregnant should be aware that the drug Paxil has been linked to an increased number of birth defects and birth injuries in children of mothers that took Paxil they were pregnant. These heart defects, birth injuries, and birth defects include Persistent Pulmonary Hypertension (PPHN) lung damage, heart valve defects, ventricular valve defects, abnormal cranial shaped heads, pulmonary failure and other birth injuries.
Infant Birth Injury Lawsuits, Infant Heart Defect Lawsuits, Child Heart Defect Lawsuits, Paxil Infant Heart Problem Lawsuits, Paxil Infant Heart Valve Lawsuits, and other Birth Defect Lawsuits
Avoidable birth defects are one of the most devastating problems that can occur to a family and a new baby. Parents who should be celebrating the birth of a new child, are often caught off guard when their child is born with severe disabilities and often do not realize that someone may be responsible for the birth injury or defect including drug manufacturers that hid information about medications that can cause birth defects. The family is typically busy taking care of the child with the serious health problems and often does not know that the birth defect was preventable. When they discover the probable cause of the preventable birth defect they are often filled with anger and rage. To find out that their child will have permanent health problems or that they lost their baby because a drug company hid research and did not provide an adequate warning of a product's safety can be extremely difficult.
FDA Advising of Risk of Birth Defects (including Heart Defects) with Paxil Agency Requiring Updated Product Labeling
In 2005, the Food and Drug Administration alerted health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.
FDA is advising health care professionals to discuss the potential risk of birth defects with patients taking Paxil who plan to become pregnant or are in their first three months of pregnancy. Health care professionals should consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients. In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate.
FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus. Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy. Women taking Paxil should not stop taking it without first talking with their physician.
The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.
In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy.
FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.
Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.
Paroxetine, Seroxat, and Paxil Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs) PPHN Birth Defect Lawsuits
Paroxetine (trade names Seroxat, Paxil) is a selective serotonin reuptake inhibitor (SSRI) antidepressant that has been linked to birth defects and birth injuries including Persistent Pulmonary Hypertension (PPHN), Paxil Heart Defects, Paxil Lung Damage, and Paxil Cranial Defects.
Paroxetine (trade names Seroxat, Paxil) is a selective serotonin reuptake inhibitor (SSRI) antidepressant that has been linked to birth defects including Persistent Pulmonary Hypertension (PPHN), heart, lung, abdominal and cranial defects. Women that have taken Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs) after the 20th week of pregnancy have a 6-fold increased risk of having their child develop persistent pulmonary hypertension, a life-threatening lung disorder. Infants with persistent pulmonary hypertension have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies and may become very sick or die.
The SSRIs antidepressants that have been linked to persistent pulmonary hypertension (PPHN) include Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac sold by Eli Lilly; Celexa and Lexapro by Forest Laboratories, Effexor marketed by Wyeth, Luvox by Solvay, and the generic makers of these drugs include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.
Infants born with PPHN often require mechanical assistance to breath and even worse about 10% to 20% of the infants do not survive even when they receive treatment. The PPHN babies that do survive often experience developmental delays, brain abnormalities and hearing loss, experts say.
Other birth defects that have been associated with SSRIs include Anencephaly, a neural tube defect where much of the brain does not develop; Craniosynostosis, an abnormality in which connections of the skull bones close prematurely; and Heart birth defects including septal defects and ventricular defects.
SSRIs have not only been associated to birth defects, but have been associated with increased risk of suicide. For more information on suicide claims from antidepressants, please see our antidepressant suicide claim information page.
Paroxetine, Seroxat, and Paxil Failure to Warn Birth Defect Lawsuits
In 2009, a jury awarded a family $2.5 million in a lawsuit filed against the makers of Paxil that alleged the drug was responsible for a young boy's birth defects. The lawsuit claimed that the family's young child suffered from birth defects, including two holes in his heart, which required surgery. In the wake of this verdict, GlaxoSmithKline has offered to settle many Paxil lawsuits.
Other medications, products, and drugs have also been linked to birth defects and some are the subject of lawsuits. Some of these medication and products have ample warnings that warn pregnant women to avoid taking these products while they are pregnant, however, some manufacturers have hidden the real dangers of their product in order to sell more of their product and value profits over healthy babies. For these manufacturers, they may have short term profits, but over the long term they will suffer for the long term birth defects that they have caused.
For more information on Infant Heart Defect Lawsuits, Selective Serotonin Reuptake Inhibitor Antidepressants (SSRIs) PPHN Birth Defect Lawsuits, and Paxil Lawsuits, please go to the following web pages: Infant Heart Defect Lawsuits and Paxil Birth Injury Lawsuits and Paroxetine, Seroxat, and Paxil Persistent Pulmonary Hypertension Lawsuits
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