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Off-Label Ketoconazole Use Continues Despite Risk of Death

Amanda Tejuca6 months ago

Despite one reported death and potentially deadly side effects, ketoconazole (Nizoral) tablets are still being prescribed off-label by physicians.

About the Ketoconazole Prescription Problems

While ketoconazole medications were previously approved for the treatement of skin and anil fungal infections, federal regulators removed these indications from the label in 2013. However, a recent study found that the drug is still regularly prescribed for these now unapproved uses.

According to the Pharmacy Times, some 217,000 patients received oral ketoconazole from outpatient retail pharmacies over an 18-month period ending in June 2015.

The U.S. Food and Drug administration is now reminding health care professionals that ketoconazole is only to be prescribed in the most severe cases in which alternative treatments have failed.

Potential Side Effects of Ketoconazole

According to pharmacytimes.com, the off-label use of oral ketoconazole is linked to risks of serious liver damage, adrenal gland problems, and harmful interactions with other medications that outweigh the benefits of treating the conditions.

In their study, the FDA found that the off-label use of oral ketoconazole was linked to risks of serious liver damage, adrenal gland problems, and harmful interactions with other medications that outweigh the benefits of treating the conditions. There was one reported death in which a person died from liver failure.

The FDA recommends patients discontinue the use of the tablets immediately and seek medical attention if symptoms like loss of appetite, nausea, vomiting, abdominal discomfort, jaundice, dark urine, light stools, or pain and discomfort in the right upper abdomen are present.

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