Why Is Ketoconazole No Longer Preferred In Modern Medicine?

In 2013, ketoconazole, an oral antifungal medication, was removed from the European and Australian markets due to serious hepatotoxic (liver-damaging) side effects. These side effects raised significant safety concerns, prompting regulatory actions in various countries. In the United States, stringent relabeling requirements and restrictions were imposed on prescription ketoconazole, reflecting the gravity of the issue. Canada also echoed these concerns by issuing a risk communication, alerting healthcare professionals and the public to the potential dangers associated with the use of this medication. This collective response from different regulatory authorities underscores the importance of addressing the hepatotoxicity risks associated with ketoconazole to ensure patient safety.

Ketoconazole cream has been discontinued for use due to its potential to cause severe liver damage, which can lead to life-threatening consequences, such as the need for a liver transplant or even death. This decision was prompted by safety concerns arising from reports of adverse events associated with the use of ketoconazole cream. These adverse effects were identified through extensive research and monitoring of its usage, leading to its removal from the market as of September 15, 2017. This precautionary measure was taken to prioritize patient safety and avoid the serious risks associated with the medication.

Has ketoconazole been banned? To address this question comprehensively, it’s important to provide a clear overview of the topic. In 2013, label changes were approved for oral ketoconazole tablets due to the recognition of significant associated risks. As part of these label changes, the indication for the treatment of skin and nail fungal infections was removed. Despite these regulatory adjustments, an FDA safety review conducted on January 20, 2022, revealed that oral ketoconazole was still being prescribed for these specific conditions. This raises questions about whether ketoconazole has been banned and highlights the need for a more in-depth examination of its current status and the reasons behind its continued use in certain contexts.