HT product with drospirenone wins approval.(Gynecology)

A combination hormone therapy that contains drospirenone was approved in late September for treating moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause, the first such product to contain this particular progestin.

The approval came with certain warnings in the label related to the potential for hyperkalemia associated with the progestin component. The product--which contains 1 mg estradiol and 0.5 mg drospirenone (DRSP), a synthetic progestin and spironolactone analog with antimineralocorticoid activity--will be marketed by Berlex as Angeliq. The approved dose is one tablet daily.

The product will not be available until mid-2006, according to Berlex, which also manufactures Yasmin, the oral contraceptive that contains DRSP as its progestin component.

In addition to the standard contraindications and warnings that are included in the FDA-approved labels of all hormone therapy (HT) products, the Angeliq label includes a warning about the potential for hyperkalemia in high-risk patients, because DRSP has antialdosterone activity. The warning also notes that the product should not be used in women with renal or adrenal insufficiency, hepatic dysfunction, or other conditions that predispose people to hyperkalemia.

It should be used with caution in women on other medications that can increase potassium, including NSAIDs, potassium-sparing diuretics, ACE inhibitors, or angiotensin II receptor antagonists. The label says that checking serum potassium levels during the first treatment cycle in women at high risk should be considered.

FDA approval for the indication was based on a study showing that the estradiol component of Angeliq was bioequivalent to a currently marketed estradiol product (Estrace). In another study on the endometrial effects, there were no cases of endometrial hyperplasia among almost ...