- Jan 24 Fri 2014 14:08
- Jan 24 Fri 2014 00:39
- Jan 24 Fri 2014 00:33
The FDA Warning on Ketoconazole
On July 26, 2013, the US Food and Drug Administration (FDA) released a Drug Safety Communication titled "FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems." The drug is known to be a very potent inhibitor of hepatic cytochrome P450 3A4 when used at the approved dose; indeed, it is the standard against which other such inhibitors are compared in pharmacodynamic and pharmacokinetic studies. Serious adverse effects that occurred when used in the approved dose led to France's withdrawal of the drug for use in deep fungal infections . That led to a mandatory review by other European Union (EU) and UK regulators and a similar withdrawal; the FDA essentially followed suit.
Ketoconazole Dosage in Malassezia Infection
Dermatologists have been aware of the risks posed by the full approved dosage of ketoconazole for decades and are likewise aware of less toxic options for managing dermatophyte (athlete's foot fungus) and Candida (vulvovaginal yeast) infections of the skin and nails.
- Jan 16 Thu 2014 18:16