Other safety alerts
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| The United States: Fluconazole (Diflucan): Drug Safety Communication - FDA evaluating study examining use of oral fluconazole (Diflucan) in pregnancy |
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FDA is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete.
Oral fluconazole is used to treat yeast infections of the vaginal area, mouth, and esophagus. It is also used to treat a fungal infection of the brain and spinal cord called cryptococcal meningitis that most often affects people with weakened immune systems, and used to prevent yeast infections that can spread to the rest of the body in cancer patients who have a weakened immune system. It is available under the brand name Diflucan and also as generics.
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. However, high doses of oral fluconazole (400-800 mg/day) taken by pregnant women for much longer than a single dose have resulted in reports of abnormalities at birth. In the Danish study, most of the oral fluconazole use appeared to be one or two doses of 150 mg.
Until FDA's review is complete and more is understood about this study and other available data, FDA advises cautious prescribing of oral fluconazole in pregnancy.
Health care professionals should be aware that the Centers for Disease Control and Prevention guidelines 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.
Patients who are pregnant or actively trying to get pregnant should talk to their health care professionals about alternative treatment options for yeast infections.
Please refer to the following website in FDA for details:
http://www.fda.gov/../ucm497656.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
In Hong Kong, there are 47 registered pharmaceutical products containing fluconazole in oral dosage forms, including the products approved under the brand name of Diflucan which are registered by Pfizer Corporation Hong Kong Limited. All products are prescription only medicines.
News on long term, high dose use of fluconazole may be associated with birth defects was previously issued by the FDA and Singapore HSA, and was posted on the Drug Office website on 4 August 2011 and 28 December 2011 respectively. Letters to inform local healthcare professionals were also issued on 4 August 2011. On 6 September 2011, the Registration Committee of the Pharmacy and Poisons Board decided that products containing fluconazole should include information on the reports of congenital anomalies in infants exposed in-utero to high dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester. The patient should also be informed of the potential hazard to the fetus if used during pregnancy, or if the patient becomes pregnant while taking the drug. So far, the Department of Health (DH) has not received any adverse drug reaction case related to fluconazole.
As FDA has just started the review on possible increased risk of miscarriage with the use of oral fluconazole and will communicate final conclusions and recommendations when the review is complete, DH will remain vigilant on the conclusion of the review and safety updates by other overseas drug regulatory authorities.
Ends/ Wednesday, April 27, 2016
Issued at HKT 15:00
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