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First Paxil birth defect lawsuit filed

The parents of 2-year-old Eric Jackson have filed the first lawsuit claiming that use of the antidepressant Paxil during pregnancy caused birth defects in their won. Christopher Jackson and Lisa Boden of Denver claimed the medication – manufactured by GlaxoSmithKline – caused their son to be born with severe PPHN (Persistent Pulmonary Hypertension), a condition that affects blood flow to the lungs and can cause death. After his birth in Denver, Eric was placed on a ventilator for a month, and had two cardiac catherizations and several other procedures. He remains on oxygen and medications to help him breathe. The ... Read More

Blood pressure pill doubles risk of birth defects

Some blood pressure drugs previously thought to be safe when taken early in pregnancy now appear to substantially raise the risk of major birth defects, doctors say. Babies whose mothers took ACE inhibitors in their first trimester were more than twice as likely to be born with serious heart and brain problems than those not exposed to any pressure-lowering medicines, a large study in Tennessee found. Other types of blood pressure drugs did not raise the risk to babies. The research raises troubling questions about the lack of safety data for many drugs prescribed to pregnant women. About 8 percent ... Read More

Paxil Maker Sued Over Child Born with Severe Birth Defects

The parents of a two-year old boy have filed a lawsuit against the maker of Paxil, alleging that the mother’s use of the antidepressant during pregnancy cause her son to be born with severe heart defects. Anthony and Matilda Vasquez of Bedford, Texas, sued Philadelphia- based Glaxo-SmithKline on behalf of their son, Adrian. The lawsuit, filed in Pennsylvania state court, is seeking unspecified damages for failing to warn pregnant women about the risks of taking Paxil. During the last month of her pregnancy, Vasquez learned, while receiving an ultrasound to determine the sex of her baby, that there was something ... Read More

Treatment Challenges of Depression in Pregnancy and the Possibility of Persistent Pulmonary Hypertension in Newborns

Decisions about how to treat depression in pregnant women are increasingly complex. Patients and physicians must carefully consider and discuss together the potential benefits and risks of treatment with antidepressants during pregnancy. Two new studies provide important information to be considered in making such decisions. The studies included women who had been treated with antidepressant drugs that act as selective serotonin reuptake inhibitors (SSRIs) or, in a few cases, other antidepressants. SSRI medications are the most commonly used drugs to treat depression in the U.S. The first study illustrates the potential risk of relapsed depression after stopping antidepressant medication during ... Read More

Updated Product Labeling Warns of Birth Defect

The U.S. Food and Drug Administration (FDA) recently announced that early research studies with the drug Paxil (paroxetine) suggest that taking the drug during the first three months of pregnancy may increase a woman’s risk of having a baby with birth defects, particularly heart defects. Paxil is an antidepressant drug belonging to the class of medications known as the selective serotonin reuptake inhibitors (SSRIs). Drugs in this group affect levels of the chemicals that nerves in the brain use to communicate with one another, known as neurotransmitters. Many experts believe that an imbalance among the amounts of the different neurotransmitters ... Read More

FDA Advising of Risk of Birth Defects with Paxil

The Food and Drug Administration today is alerting 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 ... Read More

FDA strengthens pregnancy warning on Glaxo’s Paxil

The Food and Drug Administration said Thursday that the warning label on GlaxoSmithKline’s widely-prescribed anxiety drug Paxil has again been revised to advise the drug may cause heart defects in babies. According to an agency release, two clinical studies have now indicated that pregnant women who take Paxil early in their pregnancy run about a 1.5% to 2% risk of bearing a child who has a hole in their heart. Expectant mothers who didn’t take the drug ran about a 1% risk. The extent of the heart defects ranged from mild to those that were severe enough to require surgery. ... Read More

New Paxil Labeling Warns Of Birth-Defect Risk

Preliminary study data suggest that the antidepressant paroxetine should not be prescribed to pregnant women. GlaxoSmithKline (GSK) late last month notified health care professionals that it was strengthening product label warnings advising against the use of paroxetine (Paxil, Paxil CR) by women who are pregnant. The company cited newly analyzed data from a retrospective epidemiologic study of major congenital malformations in infants, saying that “preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants.” Changes in the drug’s labeling are being made after consultation with the U.S. Food ... Read More

New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants

The FDA and the drug company GlaxoSmithKline are alerting doctors about a new study on major birth defects seen in babies born to women who took the antidepressant Paxil during the first trimester of pregnancy. “Healthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients,” the FDA says in a news release. Paxil Linked to Twice as Many Birth Defects GlaxoSmithKline recently conducted a study of major birth defects in infants born to women who took antidepressants (including ... Read More