FDA Approves Korlym

The U.S. Food and Drug Administration has approved Korlym (mifepristone) to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. Korlym was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women.

The most common side effects experienced by endogenous Cushing’s syndrome patients treated with Korlym in clinical trials were nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness and decreased appetite. Other side effects of Korlym include adrenal insufficiency, low potassium levels, vaginal bleeding and a potential for heart conduction abnormalities. Certain drugs used in combination with Korlym may increase its drug level. Health care professionals must be aware of the potential for drug-drug interactions and adjust dosing or avoid using certain drugs with Korlym.

Korlym can cause serious side effects, including:

Loss of a pregnancy. Women who can become pregnant must:
have a negative pregnancy test before starting Korlym
have a negative pregnancy test before restarting Korlym if you stop taking it for more than 14 days
use a non-hormonal form of birth control while taking Korlym and for 1 month after stopping Korlym. Talk to your doctor about how to prevent pregnancy. Tell your doctor right away if you think you may be pregnant.