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View Full Version : FDA warns against Zofran



marymoo86
12-22-2013, 09:52 AM
http://www.fertilitycenter.com/fertility_cares_blog/fda-warns-against-zofran-use-in-pregnancy/

swissair81
12-22-2013, 10:25 AM
I posted this on my Facebook page this morning. Then I started wondering. It's weird that they don't back up this assertion with studies. I found this recent study that says the opposite: http://www.nejm.org/doi/full/10.1056/NEJMoa1211035

ETA that OB GYN News has this article from the end of October: http://www.obgynnews.com/index.php?id=11146&tx_ttnews[tt_news]=221089&cHash=00595b8bf7a0ec96a0d280e28af9edd6 Unfortunately, the forum won't highlight the entire URL, but you need the whole thing to find the article.

♥ms.pacman♥
12-22-2013, 11:17 AM
oops. i took it in both pregnancies. luckily neither kid had any issues (minus DD being premature, which i attribute mostly to having kids 14 months apart, which i later learned is not recommended. LOL).

essnce629
12-22-2013, 04:21 PM
"Doxylamine succinate and pyridoxine hydrochloride known as Diclegis is the only Pregnancy Category A, FDA-approved prescription for morning sickness. This anti-nausea medication provides a safer alternative to pregnant women experiencing nausea and vomiting."

This is the vitamin b6/Unisom combo that a lot of us have used on here for years! I took it for both pregnancies in 2003 and 2008/2009. Glad to see it's recommended now. I've never used Zofran, but I know a lot of people who have. I've recommended the vitamin b6/Unisom combo to everyone I know with bad M/S.

doberbrat
12-22-2013, 09:45 PM
SO Glad I'm done having kids. b6/unisom was totally useless for me - zofran was the only thing that kept me out of the hospital.

babygirl1029
12-23-2013, 09:06 PM
"Doxylamine succinate and pyridoxine hydrochloride known as Diclegis is the only Pregnancy Category A, FDA-approved prescription for morning sickness. This anti-nausea medication provides a safer alternative to pregnant women experiencing nausea and vomiting."

This is the vitamin b6/Unisom combo that a lot of us have used on here for years! I took it for both pregnancies in 2003 and 2008/2009. Glad to see it's recommended now. I've never used Zofran, but I know a lot of people who have. I've recommended the vitamin b6/Unisom combo to everyone I know with bad M/S.

I do not think there is an easy answer. diclegis is simply bendictin marketed under a different name by a different pharmaceutical company because the original company went bankrupt after lawsuits that the medication caused birth defects. To my knowledge, nothing was ever proven but the FDA removed the med from the market. It was recently re-introduced. This article doesn't cite any scientific studies to provide actual evidence of side effects of Zofran so it makes me wonder who actually is behind this publication. A recent study I read indicated that of 600,000 pregnancies in Denmark there was no statistical evidence of higher rates of birth defects in the group using Zofran vs. the women who did not.

marymoo86
12-23-2013, 10:31 PM
I do not think there is an easy answer. diclegis is simply bendictin marketed under a different name by a different pharmaceutical company because the original company went bankrupt after lawsuits that the medication caused birth defects. To my knowledge, nothing was ever proven but the FDA removed the med from the market. It was recently re-introduced. This article doesn't cite any scientific studies to provide actual evidence of side effects of Zofran so it makes me wonder who actually is behind this publication. A recent study I read indicated that of 600,000 pregnancies in Denmark there was no statistical evidence of higher rates of birth defects in the group using Zofran vs. the women who did not.


I have had time to read this further as I am the OP saw it when I was putting the baby down and didn't get a chance to thoroughly read. I too wonder since there is no link back to the FDA with the study in question. I did read the Denmark one you cited but there was only 1970 of the 600,000 that actually took Zofran and IIRC they couldn't determine if there was any link to defects.