Newly approved HG drug - have you guys seen this?

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Newly approved HG drug - have you guys seen this?

Postby Jocelyn » Apr 25, 2013 12:22 pm

I saw this article a couple weeks ago, and thought I should post it here:

http://www.webmd.com/baby/news/20130409/fda-allows-return-of-once-banned-morning-sickness-pill

"A morning-sickness medication that was withdrawn from the market 30 years ago has won U.S. Food and Drug Administration approval under a new name.

In its new form, the drug -- formerly called Bendectin and now renamed Diclegis -- is the only medication specifically approved to treat the stomach upset many women suffer from during pregnancy.

In the intervening decades between the drug's withdrawal from the market and its re-approval on Tuesday, the medicine has undergone rigorous scrutiny and is now deemed safe by the FDA."

They say that "Diclegis, which combines vitamin B6 and the antihistamine doxylamine, is a delayed-release pill that's meant to be taken daily before symptoms set in." So, it's basically the B6/Unisom combo that's recommended a lot, but in one pill and delayed-release.

A doctor quoted in the article said that Diclegis and Zofran are about equal in safety.

Thoughts?
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Re: Newly approved HG drug - have you guys seen this?

Postby aaronsmommy » Apr 25, 2013 3:39 pm

A lot of people take the components of this already. It is also available as Diclectin in Canada, so if you do a search for that, you can probably find lots of posts. It seems most people with hg find it most helpful when hg is not at it's worst, or in combination with other meds.

In terms of safety, it is probably the best studied medication in pregnancy and there is 50 years of data in over 100,000 pregnancies (the ones actually studied , it has been used in millions) showing that it is safe. Zofran has a couple of very small studies of a couple hundred people and one study that actually suggests that it could be associated with cleft lip, so saying that they are equivalent in safety is probably not reasonable (although a medication that WORKS and prevents dehydration and malnutrition is the key thing).

It will be available in the US probably in the end of May.
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Re: Newly approved HG drug - have you guys seen this?

Postby aaronsmommy » Apr 25, 2013 3:46 pm

And again, the components are easily available now.
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