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Medicolegal, pregnancy, vaginal discharge

Dear FDA: a letter to those crazy kids in Washington about fluconazole in pregnancy

 

Dear FDA,

Thanks so much for your letter earlier today warning about the dangers of high dose fluconazole in pregnancy. It is nice to hear that you have changed it to a category D drug (known to cause birth defects). How 1990’s of you.

I mean seriously kids, I knew fluconazole caused multiple birth defects in my residency and that ended in 1995! But perhaps you didn’t read the article in 1992 from the Pediatric Infectious Diseases Journal describing an infant with congenital malformations due to fluconazole exposure. Then there was the article in Clinical Infectious Diseases in 1996 describing three infants with fluconazole embryopathy after first trimester use. Of course if you were too swamped to read that one when it came out, in 1997 there were two case reports on fluconazole related birth defects, one in the CMAJ (that’s the Canadian Medical Association Journal, in case you were wondering) and the other in the American Journal of Medical Genetics. And if the 90’s just blew you by, well, there was a detailed case report in 2005 regarding the typical birth defects after prolonged fluconazole exposure in a pregnancy.

We do know that a single dose in pregnancy is probably okay (as you note in your press release). There was an article from 2008 in the Journal of Antimicrobial Agents and Chemotherapy in case your reading list hasn’t caught up to the past 5 years (I know how those pesky journals keep piling up!). And if you ever attended any of my lectures you would know that while in pregnancy a yeast infection can be treated with a single dose of fluconazole, it’s probably not worth the risk (especially in our medico-legal society) when we know that a well-described embryopathy exists and there are perfectly fine topical drugs not associated with birth defects or any other safety concern.

I guess my point is why this press release now? I scoured Pub Med and can’t find a recent article, although I don’t think I need one because I’ve read the articles I referenced above. The medical evidence was as clear in the 90’s as it is today. I’m just wondering if this the kind of busy work that prevents you from keeping a closer eye on those pesky medical devices that keep popping up?

Next time I’m in Washington lets do lunch, okay?

Warm regards,

Jennifer

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Discussion

2 thoughts on “Dear FDA: a letter to those crazy kids in Washington about fluconazole in pregnancy

  1. Thank you for being the voice of reason-What the hell is wrong with the FDA? (got a few hours to discuss?). None of us use azoles in the first trimester especially, and we only use topicals for candida in pregnancy. I’m a CNM in practice for 21 years in NJ. Enjoying your twitter/blogs immensely.

    Posted by joannyates | August 4, 2011, 2:58 pm

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