Nauseous and Pregnant? Be Careful of What Medicine You Take

A pregnant woman experiences a great deal of discomfort during the nine months she is carrying the child, most notorious of which is the dreaded nausea and vomiting that is morning sickness. Understandably, many pregnant women seek medication to relieve this discomfort. Doctors have commonly prescribed Zofran to eliminate nausea and vomiting, and the drug has been very effective at doing so.  Unfortunately, some of the women who used Zofran gave birth to children with birth defects, and several studies have shown that Zofran is linked to those defects.

Zofran, which is manufactured by GlaxoSmithKline (GSK) was approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting that was caused by chemotherapy and radiation [1].  GSK also promoted to treat morning sickness in pregnant women. Even though the drug had not been approved by the FDA for this use, doctors prescribed it “off-label” to treat nausea and vomiting during pregnancy. Because of the promotion by GSK for the non-approved use of Zofran, the Department of Justice sued GSK in 2012 for unlawful promotion and failure to report safety data on a number of drugs, including Zofran.  Zofran plead guilty to the unlawful promotion of Zofran to treat morning sickness. GSK paid $3 billion to settle the allegations.

Off-label use, which is the use of medication for anything that is not its approved use, is fairly common. While there is no law that prohibits a doctor from prescribing an approved medication for an off-label use, however pharmaceutical companies are not permitted to promote a drug unless the FDA has given express approval. Despite the fact that a doctor may, in his or her best professional judgment, prescribe a drug for an off-label use, the off-label use of the medication means that there have not been clinical trials or studies as to the drug’s use. A pharmaceutical company is required by the FDA to thoroughly test and analyze the effects of a certain medication on the people who would likely be using it, but an off-label use means that there has been no testing done to see what the potential effects would be. This means that it would be impossible to warn future users of a medication of possible risks that they may face, as the pharmaceutical company has not done the research necessary to even know what those risks would be.

The Center for Birth Defects Research and Prevention published a study in 2012 that suggested that women who had used Zofran during the first trimester of pregnancy had an increased risk of giving birth to a baby with birth defects. The babies were twice more likely to develop defects than babies whose mothers had not used Zofran. These defects included cleft lip, cleft palate, kidney defects, congenital heart defects, and fetal death.

A separate study of Danish women was published in the American Journal of Obstetrics and Gynecology in 2014, and highlights the issues that may arise after pregnant women take Zofran [2]. That study found that 80 percent of women experience nausea and vomiting during pregnancy, and about 1 million women are exposed to Zofran (or its generic counterpart) each year. Zofran was more effective than other medications in reducing nausea and vomiting, which lead to it commonly being prescribed by doctors for morning sickness.  This study found that women who took Zofran had almost a 30 percent increased risk of giving birth to a child with a birth defect.

In Massachusetts and Minnesota, lawsuits have been filed recently against GSK claiming that Zofran use during pregnancy caused birth defects in the newborn children. Both of the affected victims in that case point out that Zofran was not approved to be used by pregnant mothers, and the safety of its use during pregnancy was not well studied.

If your child has developed cardiac malformations or oral cleft birth defects after you or the child’s mother used Zofran during pregnancy, you may be entitled to file your own claim against GSK. Please do not hesitate to contact the New Jersey Lawyers for injuries at the Clark Law Firm, P.C. for a consultation. Our personal injury attorneys are experienced in products liability litigation and can provide you with important guidance and support in these kinds of pharmaceutical matters.

[1] http://central-pennsylvania.legalexaminer.com/defective-dangerous-products/new-study-warns-about-zofran-birth-defects/

[2] http://www.drugwatch.com/2015/02/18/zofran-may-increase-risk-of-birth-defects/