If you are taking danazol do you need an ultrasound and/or MRI yearly to monitor your liver?

Jun 24, 2015

Dr C: Greetings from Budapest where we are attending an international meeting on HAE.

Prior to 2008 with the exception of antifibrinolytics, attenuated androgens such as danazol were all that we had available for prophylaxis of angioedema attacks in the United States. While effective for many patients, attenuated androgens have a myriad of potential associated side effects. With regard to our questioner’s concern, danazol and other attenuated androgens have been associated with a variety of liver problems, ranging from elevated liver function enzymes, to hepatitis, benign and malignant liver tumors and liver failure. We unfortunately do not have adequate data to determine the absolute risk of the more serious side effects and liver function abnormalities are not necessarily predictive. Given this we should err on the side of caution for monitoring. Routine screening including checking liver function and imaging has been recommended in multiple guidelines. Any thoughts on this Marc or Bruce?

Dr R: Annual liver ultrasound for individuals on androgen therapy is generally a good idea and in line with recent consensus treatment guidelines for HAE. Androgen treatment can potentially cause a number of liver issues, so in addition to regular blood tests to screen for liver toxicity, the ultrasound is useful for catching liver tumors than can be associated with androgen use. These tumors are rare but potentially very serious complications – thus the reason for the recommended imaging.

Dr. Z: Because most of the side effects of danazol are thought to be dose-related, the need to image the liver is usually based on the dose of androgen that patients use. At a dose of 200 mg per day of danazol, ultrasound is generally recommended. MRI is not typically done unless the doctor suspects other problems such as peliosis hepatis.

Dr. C: I’d just like to emphasize that androgens such as danazol must be used at the lowest possible dose. In general, we never recommend using a dose above 200 mg/day except for short-term prophylaxis. Patients should always be informed as to the risk/benefit of any therapy and alternatives currently available for management of HAE.

Hopefully this provides some clarity as to the need for regular monitoring for patients on danazol. We’ll be back in the United States next week and look forward to the next question of the week.

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