FDA evaluating the safety of oral fluconazole in pregnancy.

In the light of new evidence linking oral fluconazole to miscarriages the FDA is currently reviewing the safety of oral fluconazole as a vaginal yeast infection treatment in pregnancy. This review comes in the wake of Danish study published in JAMA which reports abnormalities at birth when  oral fluconazole is taken in higher dose of 400-800 mg/day.

It was a Nationwide register-based cohort study in Denmark from 1997-2013. From a cohort of 1,405, 663 pregnancies, 3315 women were exposed to oral fluconazole from 7 through 22 weeks’ gestation. About 147 experienced a spontaneous abortion compared with 563 among 13,246 unexposed matched women (HR 1.48).

The current FDA drug label states that data available from studies in people do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150 mg dose of oral fluconazole to treat vaginal yeast infections.

FDA cautions the healthcare professionals about the use of this drug until the review is complete. The agency has previously classified it as  pregnancy class D, meaning that there is evidence of risk to the fetus, but it may be used if the mother's condition is serious or life-threatening.

CDC guidelines also recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur.

FDA is also urging people and researchers to report any untoward effects of the drug. It is also reviewing additional data related to the drug use in pregnancy.

In addition to its use as antifungal for vaginal yeast infection, it is also used to treat infection of mouth, and esophagus. fungal infection of the brain and spinal cord called cryptococcal meningitis.

References:

Mølgaard-Nielsen D, Svanström H, Melbye M, Hviid A, Pasternak B. Association Between Use of Oral Fluconazole During Pregnancy and Risk of Spontaneous Abortion and Stillbirth. JAMA. 2016;315(1):58-67. doi:10.1001/jama.2015.17844.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm497656.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Caution in using oral fluconazole during pregnancy

Vulvo vaginal candidiasis (VVC) usually is caused by C. albicans but can occasionally be caused by other Candida sp. or yeasts as C. glabrata, C. tropicalis, C. krusei and C. parapsilosis.

Vaginal candidiasis is common during pregnancy.

According to Center for Disease control (CDC) an estimated 10-15% of women will have one episodes of Vaginal candidiasis  in pregnancy.

According to CDC 2015 Sexually Transmitted Diseases Treatment Guidelines only topical azole therapies, applied for 7 days, are recommended for use among pregnant women.

But, in cases of recurrence or severe symptoms or when topical treatment has failed oral fluconazole is often used despite of limited safety information available.

According to a recent study published in Journal of American Medical Association (JAMA) on January 5, 2016, a link is found between the use of oral Fluconozole in pregnancy and the risk of spontaneous abortion or still birth down the lane.

This is a nation wide register based cohort study by Danish researcher spanning 17 years and studying 1,405,663 pregnancies.

The pregnancies were matched on other confounding factors!

Of 3315 women who took oral fluconazole during the 7th through 22nd weeks of gestation, 147 had a spontaneous abortion. In contrast, of 13,246 matched controls (pregnant women with no fluconazole exposure), 563 had spontaneous abortions, a difference that translated into a hazard ratio (HR) of 1.48.

An increasing trend towards stillbirth was also seen in women who took oral fluconazole, when comparing with unexposed matched controls or unexposed unmatched pregnant women, but these differences were not statistically significant, reported the researcher from   the Department of Epidemiology Research at Statens Serum Institut in Copenhagen, Denmark.

A higher association was noted as the dose increased from the routine dose of 150 milligrams.

So it means that scientists concluded that women in this Danish study who used the drug during the first six months of pregnancy were almost 50 percent more likely than nonusers to have a miscarriage.

While this study does not establish a cause- effect relationship, but it does warrant larger studies, more research and a caution to physician and patient about the use of oral fluconozole in pregnancy.

Dr Scott Sullivan, a member of the ethics committee at the American Congress of Obstetricians and Gynecologists, said the new study doesn't prove any miscarriage risk from fluconazole, 'it just means we need more data, more studies'.

The researcher also urged patients in being caution taking fluconozole while pregnant as it is freely available over the counter.

References:

http://www.sciencemediacentre.org/expert-reaction-to-study-investigating-oral-medication-for-thrush-in-pregnancy-and-risk-of-miscarriage/

http://www.bmj.com/content/352/bmj.h7029.short?rss=1&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+bmj%2Frecent+%28Latest+from+BMJ%29

http://www.wallstreethedge.com/popular-yeast-infection-pill-heightens-miscarriage-risk/28271/

http://www.medscape.com/viewarticle/856792

http://jama.jamanetwork.com/article.aspx?articleid=2480487#References

http://www.cdc.gov/std/tg2015/candidiasis.htm