News Tagged ‘Food and Drug Administration

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’ risk 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 antidepressants 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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ACOG Issues Opinion on SSRI Antidepressant Use During Pregnancy

Washington, DC — The use of selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors for the treatment of depression during pregnancy should be individualized based on their respective risks and benefits, according to a new Committee Opinion issued by The American College of Obstetricians and Gynecologists’ (ACOG) Committee on Obstetric Practice. The Committee also advised that a particular SSRI medication known as paroxetine (Paxil®) be avoided, when possible, by pregnant women or women planning to become pregnant due to the potential risk of fetal heart defects, newborn , and other negative effects.

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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 risk 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 risk of major birth defects, doctors say.

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Updated Product Labeling Warns of Birth Defect

The U.S. (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.

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FDA Advising of Risk of Birth Defects with Paxil

The 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. 

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FDA strengthens pregnancy warning on Glaxo’s Paxil

The 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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