Paxil Linked to Serious Birth Defects
Paxil (paroxetine), a popular antidepressant, has been linked to an increased risk of fetal heart defects in women who take the drug during the first trimester of pregnancy. Paxil side effects in a fetus can be disabling or life threatening and may require lifelong medical care for the child. The most common side effect of Paxil is heart defects including holes in the heart and malformation of heart valves.
Paxil Studies Reviewed by FDA
Depression, caused by changing hormone levels, is not uncommon in early pregnancy and doctors often prescribe antidepressants to help patients deal with fatigue and other symptoms. Until 2005, most doctors believed that Paxil was safe for use during pregnancy.
Paxil is in a class of antidepressants called SSRIs (selective serotonin reuptake inhibitors). Clinical researchers have had some concerns about the effects of this class of drugs on the unborn. Studies of drugs and their effects during pregnancy are usually carried out on laboratory animals and may not accurately reflect the risk of side effects for human fetuses. Many drugs carry the label “not tested on pregnant women”.
The FDA did issue a warning in December 2005 advising doctors and pregnant women that Paxil might increase the risk of Paxil heart defects in fetuses that were exposed to the drug, especially in the first trimester. These warnings were issued after the FDA reviewed two studies which indicated that Paxil increased the risk of heart defects in fetuses one and a half to two times over women who did not take the drug.
A later warning was issued that stated Paxil “should generally not be initiated in women who are in the first trimester of pregnancy or in women who plan to become pregnant in the near future.” The drug was reclassified by the FDA and drug maker, GlaxoSmithKline, as a Category D drug for women during pregnancy, meaning the drug has shown a risk of side effects for infants who were exposed in utero.
Some studies reviewed by the FDA have had conflicting results. Although two studies linked persistent pulmonary hypertension in newborns (PPHN) to Paxil use during pregnancy, three others did not did not find any evidence of an increased risk of PPHN for women who used Paxil. The FDA released their review in December, 2011 and recommended that pregnant women taking antidepressants continue taking their medication.
Report from Swedish Study of Paxil
A study conducted in Sweden reported that birth defects of the heart were twice as common in Paxil users as in women taking other antidepressants or no antidepressants. While most defects were not severe and healed on their own, more serious defects required surgical repair. The prevalence of heart defects in newborns for women not using Paxil or other drugs is about 1%.
Approximately 25% of patients using Paxil are women between the ages of 18 and 45 who may become pregnant. Women who become pregnant while taking Paxil should consult their doctors before they stop taking the drug.
Lawsuits for Paxil Birth Defects
After December 2005, GlaxoSmithKline changed Paxil labels to reflect the risks of taking Paxil during pregnancy. Women who took the drug during the first three months of pregnancy prior to December 2005 and had a child with PPHN, omphalocele, hydrocephalus, craniosynostosis or heart defects may have grounds for a Paxil lawsuit. An attorney can advise you of your legal options.
Filing a lawsuit for Paxil birth defects may help you recover money to cover ongoing medical expenses, lost income or other costs incurred due to your child’s birth defect.
In 2007, Michele David filed a lawsuit suit against GlaxoSmithKline on behalf of her 3 year old son, Lyam Kilker, who suffered life threatening heart defects which Ms. David alleged were due to her use of Paxil during the pregnancy. Lyam had to undergo two heart surgeries and will have to have additional surgeries as he grows to correct the heart defects caused by Paxil. A Philadelphia jury awarded Lyam $2.5 million dollars for his injuries. GlaxoSmithKline is appealing the verdict stating that the boy’s condition is extremely rare and there is no evidence linking Paxil to his heart defects.
While GlaxoSmithKline continues to maintain that Paxil is not responsible for causing birth defects when taken during pregnancy, they have reached out of court settlements in at least 800 Paxil lawsuits at a cost of approximately $1 billion dollars. According to an article in published by Bloomberg, evidence in the Kilker trial indicated that GSK was aware of the potential risks as early as 1980, but declined to perform animal tests to determine if the drug was responsible for the high rate of deaths among newborn rats exposed to the drug. They appear to have withheld vital information about Paxil birth defects from the FDA and the public.
Paxil Legal Help
Women who took Paxil during the first trimester of pregnancy before December of 2005 and had a child with Paxil birth defects may be entitled to legal consideration for the child’s injuries. To get a free compensation evaluation, simply complete our short questionnaire. Our trained professional staff is available to answer your questions and help you find an attorney in your area to pursue your legal rights.