endstream endobj startxref FDA And Drugmaker Warnings About Zofran® For Patients And Prescribers Anti-nausea medications can be lifesaving for patients undergoing chemotherapy and recovering from invasive surgeries. The million dollar question for pregnant women is: will Zofran lead to birth defects?Back in 1999, the FDA warned the makers of Zofran, GlaxoSmithKline, to stop marketing it as an anti-morning sickness drug. Zofran is a 5-HT3 receptor antagonist approved by the FDA for preventing nausea and vomiting related to cancer chemotherapy and surgery. ldy���X`m�Pϲ)�������܇� k�$���:��R=�����04r�o�(�>��(���C g���~���8�a�G�>��CV�}X�ң+��;�X�R���d�ۜ�������>gU���9�Y^��B�����,/fy1ˋY^��b������,/fy������*�s�s�s�s�s���,Oey*�SY���T���?�AxE8i���8t��t�Q���8�\�:�Sn��\Ī���u�]��¡�8�\�v`c�\�J�Y\��*���ə8xZ�E�j�|�_�E�9kTMm��C���c�e�_u��#�k�.z]�pM4Wz�C�������Mz�}P���M]:�i�1���Yo*����^���A�I8 Years later, in 2012 specifically, GlaxoSmithKline paid three billion dollars to settle those claims, among others involving other drugsA year later in 2013, the FDA warned pregnant women not to take Zofran due to an increase in birth defects such as a cleft palate and heart defects.The FDA also raised an issue regarding pregnant women who had an electrolyte imbalance due to severe morning sickness.It was concerned about what’s called Serotonin Syndrome, which is a combination of cognitive and behavioral changes that can occur when there is too much serotonin in the body.The FDA advised that the only safe anti-nausea medicine for pregnant women was DiclegisSince then, there have been hundreds of lawsuits filed by women who took Zofran and claim their baby’s birth defects are a result of them taking the drug.There have been many studies done where researchers found an increase in these conditions in babies born to pregnant women who took Zofran versus those who did not.In 2004, Canadian and Australian researchers published a study that found women who took Zofran during their first trimester had a 3.5% higher chance of having a baby with a major birth defectIn another study conducted between 2002 and 2005, Australian researchers found a 20% increase in birth defects in babies born to women who took Zofran during their first trimester.Swedish researchers who looked at pregnant women who took Zofran during their first trimester between the years 1998 and 2012 found that Zofran was not linked to an increase of severe birth defects.However, they did find the odds of general heart defects were 1.6 times higher while the odds of a problem with the heart septum were 2.1 times higherDespite those studies and the numerous lawsuits filed, there is research to support the use of Zofran during pregnancy.A study by Denmark researchers, published in the New England Journal of Medicine in 2013, looked at more than 600,000 pregnant women, those who took Zofran and those who did not.They did not find any increase in birth defects, still births or miscarriage in women who took the drug when compare to those who did not.There was also no increase in pre-term labor and or low birth weight in those who took ZofranA 2016 study done by a UCLA researcher found that taking Zofran during pregnancy for morning sickness does The study looked at 1,000 women who took the drug during their pregnancy.He found that women who took Zofran for morning sickness during their pregnancy did not give birth to more babies with birth defects than women who never took the drug.Specifically, among 952 infants whose mothers took Zofran for extreme morning sickness, five had heart defects and one had a cleft palate.Of the 1,286 infants who’s mothers didn’t experience extreme morning sickness and didn’t take Zofran, there were eight heart defects and two cleft palatesIn fact, his research found that women with morning sickness who took Zofran actually had fewer miscarriages and higher live birth rates than women who did not take the drug for their morning sicknessIn the study, the researcher said that taking Zofran helped women to get through their pregnancies and have successful births.If you want to ease your morning sickness but are still unsure if you should be taking Zofran, there are other avenues some doctors recommend.Some foods you eat can work to ease the yucky feelings that are often associated with morning sickness.The American Pregnancy Association advises eating plain, bland foods over spicy foods or foods with a strong odor.We know they may not taste as good, but if they’re going to stop you from throwing up every hour, it’s a worth a try, right?Other foods you may want to add to your diet includeYou may also want to drink fluids ½ hour before or after meals and not during meals to avoid feeling too full or too empty.These feelings can also bring on nausea in some women.Talk to your doctor about taking a natural vitamin B-6 supplement. According to the American Pregnancy Association, more than 50% of pregnant women experience morning sickness at one time or another during their pregnancyWhile some women may get sick and can move on with their day, for others that nausea can be debilitating and can leave them down for the count.If you’re part of this group, you know exactly what we’re talking about. She has written several books on medical topics, and has extensive experience caring for women of childbearing age, women in pregnancy, and menopausal women.As a writer and editor, she specializes in writing coursework for medical students and other healthcare providers, with a predominance of writing on general medical topics and premedical scientific topics. The FDA also raised an issue regarding pregnant women who had an electrolyte imbalance due to severe morning sickness. By continuing to browse this site you are agreeing to our use of cookies. h�bbd``b`�$�@D7���bY �=@���5D���^ ��H���X�@���C�x$�����q =����A$��8J� �w������ C� The popular anti-nausea drug Zofran may increase a pregnant woman’s risk of deadly heart problems and serotonin syndrome, according to the FDA. 3. receptor antagonist. If you need assistance with your Wolters Kluwer products or would like to get more information on a complimentary Guest Pass to any of our online products, please contact your representative. She has written thousands of articles for laypeople and professionals alike on a variety of medical subjects.I haven’t had any morning sickness during the first trimester of my pregnancy. Bradley Thomas (Shook, Hardy & Bacon LLP) for GlazoSmithKline, LLC and GlaxoSmithKline LLC. Zofran has been FDA approved since 1991, and pregnant women have been taking it for more than a decade, so the health community has sufficient data to initiate epidemiological studies on its own. %(�!p�`I�-+H9�� �,5xAF�$����(�K'T���aQ ��'��Jq���&�[Fh�.��J��Ρ��G� BG�.Fa�ӌE Until the FDA changed its letter rating system in 2015, Zofran, Zuplenz and the generic ondansetron were labeled as Pregnancy Risk Category B, meaning there is no evidence of risk to humans. C��* ��j�PX#�p襤��{'���++6p�X��qe��`e9B� ����Y�[�' U�Cm$��ĝr��re"�⎽&h�o�X�-ȥ�kH^���% 4 CONTRAINDICATIONS .