The US Food and Drugs Administration (FDA) in its latest Drug Safety Communication has warned the patients and healthcare prescribers regarding the use of an oral antifungal agent, ketoconazole tablets. This drug should not be prescribed for treating unapproved conditions, for example, skin and nail infections.

Its prolonged use in these conditions may cause serious damage to the patient’s health and can also be fatal. Its use for the unapproved conditions can cause problems of adrenal glands, liver cirrhosis as well as causing dangerous interactions with other drugs. This drug should not be used except for approved conditions. Using ketoconazole for the unapproved conditions can easily outweigh its benefits.

As a result of the serious adverse effects associated with the oral ketoconazole tablets use, the US FDA in 2013 recommended changes in the labels. These changes resulted in the removal of indications for treating fungal infections of nails and skin from the labels of the tablets. In a database survey conducted by the US FDA, it was found that these tablets are still prescribed for the above two conditions by the physicians. The only indication found regarding the use of oral ketoconazole tablets by the analysis of 18-month data from physicians prescribing database was skin infections. This data was collected after the labeling changes for oral ketoconazole tablets by the FDA were issued on July 2013, and was collected over a period of 1.5 years ending in June 2015.

The 2013 drug safety information by the FDA has warned Nizoral tablets’ use as the first line treatment choice for all antifungal infections. It was identified that its use can seriously damage the liver, may cause injury to the adrenal glands and can cause severe drug interactions. As a result, the labels of the tablets were changed and the indication for its use in treating skin and nail fungal infections were removed as the adverse effects are potentially of great danger than these less life threatening fungal infections. So their use for these indication can cause some serious or fatal damage to the patients.

It was observed that physicians were still prescribing the drug for treating unapproved conditions like skin and nail fungal infections. Since the changes in the labeling, one patient has died due to the liver cirrhosis that was linked with the use of oral ketoconazole tablets. The drug was prescribed for that particular patient for treatment of fungal nail infections.

Advise For The Patients And Healthcare Providers

The physicians and other healthcare providers are advised by the FDA not to use ketoconazole tablets for treating conditions like skin and nail fungal infections. They should only prescribe these tablets if other alternate treatment options are unavailable or in treating severe fungal infections. Usually skin and nail fungal infections are not life threatening and can be treated by using other over-the-counter (OTC) medications. If this drug is used in treating the above conditions, its harmful effects may overshadow its beneficial effects.

Similarly, the patients are advised to know about all the benefits, side effects and adverse effects of the therapy before the start of the medication prescribed for treating nail and fungal skin infections. They should discuss everything about their antifungal therapy with their prescribers and should inform their physicians immediately if they experience any type of symptoms including nausea, vomiting, discomfort of the abdomen, appetite changes and problems of the liver or upper area of the abdomen where the liver is located. The other noticeable symptoms are pain in the upper abdominal cavity, stools lightness, jaundice (paleness of the whites or the skin), dark colored urine and lightness of the stool color. If any of these symptoms appear, the patients should immediately consult their healthcare provider.

About The Ketoconazole

Ketoconazole(Nizoral) is a broad spectrum antifungal agent. It acts by blocking the production of ergosterol which is a key component of the cell membrane in the fungi. As a result, the growth of the fungal cells is stopped and finally they get destroyed. It is only indicated for serious fungal infections that cannot be treated properly with other drugs. Oral ketoconazole (Nizoral) is available as tablets. It was observed by the US FDA that within a period of one year — from June 2014 to June 2015 approximately — 217,000 patients received this oral prescription drug from the US retail and community pharmacies. This drug is only available as generic. The topical forms of this drug are not associated with any sort of drug interactions, adrenal gland problems or liver cirrhosis.