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Wednesday, May 15, 2013

After Three Decades of Being Withheld a Popular Nausea and Vomiting Medication Is Back For American Pregnant Women

10% of Women of Reproductive age Get Pregnant Each Year, and many will have morning sickness. It's been a huge dilemma for women and their physicians as to how to treat this nausea and vomiting that is so common, because until right now we have not had an approved medication. It's not that we don't like to use any medication. About two thirds of  pregnant women are prescribed medications during pregnancy that are not their vitamins.  If you want to know what you are taking is safe for a developing pregnancy, read the label, but it's probably confusing to both you and your gyno as often the label may contradict the science behind the medication safety. Some medicine is clearly not safe, but other mediation is safe but not labeled as such. . And the language it's written in and the research it's based on may be as confusing to your gyno as to you! And when you ask your gyno medication safety questions, the most important question to start with: what is your background risk of having a complication? About 2-3% of women have birth defects regardless of whether they have medical complications to their pregnancy.
Nausea and Vomiting of pregnancy currently is reported in about 85% of all women who are pregnant.Nausea and vomiting in pregnancy is more common in first pregnancies and it is most likely to be resolving by the third month. There's always been a popular wives belief that a "sick pregnancy" leads to an easy confinement. Since the nausea and vomiting more likely occur in the morning we have always called pregnancy nausea "morning sickness." We have long struggled with whether the medicines we use to treat nausea and vomiting in pregnancy, whether it causes an easier birth or not, but are the medicines used to treat this actually safe. We once had a drug in the US called Bendectin, and in 1983 it was removed from the us market for presumed safety questions with regards to birth defects. It was the combination of doxylamine and Vitamin B6. That very combination is still sold in Canada, by the company Duchesnay, without any undue reports of abnormalities. And the FDA has now announced that  their medication containing 10 mg of the doxylamine and 10 mg of the vitamin B6 is approved for "the treatment of nausea and vomiting of pregnancy for women who do not respond to other therapy." It will probably be available by late May 2013.
In the USA we have an approved sleep medicine called Unisom, and it's actually doxylamine, so we used to be able to cobble together the old combination to use if we want to.  More recently gynos have switched to using ondansetron. The use of this medicine grew rapidly because it was so effective, long before any safety studies were published. Then the safety studies were "look back" or what is called retrospective studies and they were often big!
As many as 5000 women, and the good news was that the look back studies showed that there were no reasons for the physicians to feel that this drug was not safe. There are lots of ways to track the safety of the medications that you are taking when you are pregnant.So do feel safe if it is still what you are using until the new medication gets back on the market. It's important to know if there are new alerts or new studies, so keep vigilant in watching the news and talking with your health care provider. Your physician might be using PubMed or the Web of Science to find answers to questions regarding exposures and risks, and you can check these sources as well, if you would like to.

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