Oral Ketoconazole HRA Recommended for Approval for Cushing's Syndrome

by Dr. Simi Paknikar on  September 30, 2014 at 6:14 PM Health In Focus   - G J E 4
Here is some hope for people of the European Union suffering from Cushing's syndrome who cannot undergo surgery. The European Medicines Agency has recommended the approval for the use of a drug Ketoconazole HRA, which contains the active ingredient ketoconazole, for the use in Cushing's syndrome. Ketoconazole HRA originally was designated as an 'orphan medicinal product' on 23 April 2012. The applicant for this medicinal product is Laboratoire HRA Pharma.
 Oral Ketoconazole HRA Recommended for Approval for Cushing's Syndrome
Oral Ketoconazole HRA Recommended for Approval for Cushing's Syndrome

Cushing's Syndrome Treatment:

Cushing's syndrome is a hormonal disorder where there is excess of the hormone cortisol in the body. The condition can be life-threating, with the patient suffering from diabetes, hypertension and other complications. Cortisol is normally produced by the adrenal glands, and its secretion is controlled by parts of the brain called the hypothalamus and pituitary. Thus, a pathology like a tumor in any of these parts could result in Cushing's syndrome. In addition, Cushing's syndrome is also caused by intake of high doses of glucocorticoids over prolonged periods. These patients may recover once their dosage is reduced. In instances where the Cushing's syndrome is due to a tumor, surgery or radiotherapy may be necessary.


Ketoconazole is an antifungal drug that is commonly used as a topical medication against fungal infections. Its oral form is used very cautiously or is banned in some countries due to its damaging effects on the liver. Beside its antifungal effects, ketoconazole is also an enzyme inhibitor and has to be used cautiously with other medications.

Ketoconazole HRA for Cushing's syndrome:

The European Medicines Agency has recommended the approval for use of Ketoconazole HRA for the treatment of Cushing's syndrome. Ketoconazole is effective in the treatment of Cushing's syndrome due to its enzyme inhibitory activity. Ketoconazole inhibits the enzymes necessary for the formation of cortisol hormone, and thereby reduces the level of the hormone. This approach could be especially useful in those individuals who cannot undergo surgery for some reason, or in whom surgery does not produce expected results. The beneficial effects of ketoconazole in Cushing's syndrome are well documented, since it was being used for this purpose for several years despite not having an official approval.

The concern of side effects of oral ketoconazole, especially liver toxicity, does prevail in these patients as well. It is therefore recommended that only physicians specialized in the treatment of Cushing's syndrome should use this medication. Its use in Cushing's syndrome is based on the premise that the benefits of the medication outweigh the risks in this condition.

As Ketoconazole HRA moves forward in the approval process for the treatment of Cushing's syndrome, it is hoped that several people with Cushing's syndrome will benefit from the use of this medication in the near future.

Source: Medindia

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