Articles Posted in Birth Defects

Young adults born with cleft lip or cleft palate birth defects may be able to seek justice by filing a Zofran lawsuit.

GlaxoSmithKline’s (GSK) anti-nausea drug was approved by the U.S. Food and Drug Administration (FDA) in 1991 to treat nausea and vomiting related to cancer treatments. Doctors also prescribed Zofran to treat morning sickness, but the drug was never approved for pregnant women.

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Women who suffer a fever early in pregnancy may have a slightly increased risk of giving birth to babies with certain birth defects, a review finds.

Numerous studies have suggested a link between fever during pregnancy and increased birth defect risk. The research team found that across 46 studies in the past 20 years, fever during the first trimester — when birth defects typically take shape — was tied to a 50 percent to three-fold increased risk of cleft palate, heart defects and serious malformations of the brain and spine called neural tube defects.

“These are rare events,” said Dr. Siobhan Dolan, an obstetrician and medical advisor to the March of Dimes who was not involved in the review. “So even with an increased risk, the chances of it happening are low.” She said it’s unclear whether it’s the fever or the underlying infection that may be the cause.

A recent study concludes that a popular type of antidepressants called selective serotonin reuptake inhibitors (SSRIs) should be given cautiously to pregnant women because of an increased risk of miscarriage, premature birth and health problems in both the mother and her infant.

Antidepressant use has increased 400 percent over the past 20 years, the researchers reported. These drugs are the most commonly prescribed medication in the U.S. for people 18 to 44 years of age – childbearing years for most women, according to a CBS News article.

Boston researchers reviewed earlier studies that examined pregnant women who took antidepressants. Results showed “…clear and concerning evidence of risk with the use of the SSRI antidepressants by pregnant women, evidence that these drugs lead to worsened pregnancy outcomes,” said study author Dr. Adam Urato. “There is no evidence of benefit, no evidence that these drugs lead to better outcomes for moms and babies …. We feel strongly that patients, obstetrical providers, and the public need to be fully aware of this information.”

Some people — especially people needing certain drugs to prolong their lives or end severe pain – think that the FDA drug approval process is slow and tiresome. According to a recent study, the FDA approves drugs faster than either Canada or Europe. Does this surprise you?

Is that good news or bad news?

The Prescription Drug User Fee Act (PDUFA) of 1992 was passed to expand the FDA resources devoted to reviewing applications for novel therapeutics for humans and to ensure drug safety. The FDA is able to collect user fees for each new drug application in order to support what is needed as part of the review process. Nevertheless, performance standards have been associated with higher rates of black box warnings and drug withdrawals.

Every year in the United States, thousands of infants are born who have been exposed to illicit or prescription drugs prenatally, especially the abuse of pain-killing opiates like Oxycontin and Vicodin.

U.S. Senator Charles E. Schumer is calling for the FDA to change prescription drug labels to better warn pregnant women about their dangers to their unborn babies.

The troubling fact is one baby, per hour, is born addicted to prescription drugs and other opiates.

According to researchers in Ireland, the reason for cleft palate or cleft lip birth defects is caused by lack of folic acid during the first three months of pregnancy.

The Growing Up in Ireland Study performed by the department of public health and primary care at Trinity College School of Medicine wished to assess the effectiveness of folic acid supplements in preventing cleft palate and cleft lip.

A cleft lip is a separation in the upper lip while a cleft palate is an opening in the roof of the mouth. Clefts result from incomplete development of the lip and/or palate in the early weeks of pregnancy.

Pregnancy Category X means the risks involved in using Qsymia in pregnant women clearly outweigh the potential benefits. Studies in animals or humans have demonstrated fetal abnormalities. What are the fetal abnormalities? To be more specific – oral cleft birth defects such has cleft palate and/or cleft lip.

The FDA just approved a new diet drug called Qsymia. For obese post-menopausal women and for men of all ages, Qsymia has some concerns and contraindications such as increased heart rate, hyperthryroidism and glaucoma but the real danger lies with women of child bearing age who could and/o are trying to get pregnant.

Qsymia is comprised of two active ingredients – topiramate and phentermine. Topiramate (Topamax) is prescribed as an anticonvulsant and/or to prevent migraine headaches. Many women who took this drug also lost weight. Topamax previously was a Pregnancy Category C upgraded to a Pregnancy Category D in 2011. Phentermine is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet.

There is something terribly wrong about a diet drug like Qsymia when doctors and pharmacists are mandated to counsel women about birth control before prescribing and dispensing Qsymia.
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If you are pregnant or of childbearing age and plan to get pregnant, talk to your doctors about any over-the-counter, herbal, dietary supplements, and prescription drugs that you are now taking or recommended to take in the future.

Many prescription drugs cause serious birth defects.

Clinical drugs trials on pregnant women are unethical and not practiced. The safety of most medications taken by pregnant women is unknown and dependent on many factors.

However, it’s important to note that if you are now pregnant, you should not stop taking any type of medication without first talking with a doctor. Sometimes women don’t even realize they are pregnant while taking a potentially harmful drug.

What medications can cause birth defects?
Harmful drugs are thalidomide (also known as Thalamid®) and isotretinoin (also known as Accutane®). Such medications should be avoided by all women who are or might become pregnant. While some medications are known to be harmful when taken during pregnancy, the safety of most medications taken by pregnant women has been difficult to determine. Women who are pregnant or trying to get pregnant should not discount dietary and herbal products as they could be harmful to your unborn baby or have other serious side effects when taken during pregnancy.
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