News Tagged ‘FDA

Folic acid may help reduce risk of heart defects in newborns

The B vitamin folic acid has long been touted for its ability to reduce the occurrence of neural tube birth defects such as spina bifida and anencephaly when taken by the mother before and during pregnancy. Now it is being credited for possibly reducing babies’ for heart defects, according to the Atlanta Journal Constitution.

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Child is helpless victim of mother’s use of Paxil during pregnancy

Christine K’s newborn baby spent her first four days of life hooked up to tubes in an incubator at a hospital’s neonatal intensive care unit, a helpless victim of her mother’s longtime use of prior to and for the first six months of her pregnancy.

Christine K had been prescribed a combination of Paxil, Risperdal and Depakote five years prior to becoming pregnant. While pregnant she read that Paxil could be harmful to her unborn baby. She asked her doctor take her off the meds, but he insisted she stay on them.

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Babies born to women taking Paxil at higher risk for heart defects

The first warning Faith Gibson had that the hole in her 3 ½-year-old daughter’s heart was caused by the anti-anxiety drug that she thought was safe to take during pregnancy, was when she read a newspaper story about another little girl born with the same birth defect. That mother was suing drug maker GlaxoSmithKline (GSK) for failing to warn her of the of heart defects in newborns when taking Paxil during pregnancy. It was the same medication Gibson had taking since 2002 and during her pregnancy.

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Ob/Gyn Group Urges Pregnant Women to Shun Paxil

A group representing America’s obstetricians is recommending that women avoid the antidepressant Paxil if they are pregnant or planning on becoming pregnant, due to a potential heightened for birth defects.

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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 of major birth defects, doctors say.

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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 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 . SSRI medications are the most commonly used drugs to treat depression in the U.S.

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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 of having a baby with birth defects, particularly heart defects.

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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 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 for that has been seen with Paxil. 

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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.

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New Paxil Labeling Warns Of Birth-Defect Risk

Preliminary study data suggest that the antidepressant paroxetine should not be prescribed to pregnant women.

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