FDA Approves YAZ(R) to Treat Acne
The U.S. Food and Drug Administration (FDA) has approved a new indication for YAZ(R) (3 mg
drospirenone/20 mcg ethinyl estradiol) to treat moderate acne vulgaris in women who desire an oral contraceptive for birth control. With this decision, YAZ becomes the first and only oral
contraceptive ever approved by the FDA for 3 distinct indications. YAZ received FDA approval as an oral contraceptive in March 2006, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who desire an oral contraceptive in October 2006.
"This latest regulatory approval underscores the culmination of years of research that confirms the promise of YAZ and the distinctness of our innovative progestin, drospirenone, in delivering benefits that are beyond reliable birth control," said Reinhard Franzen, President and CEO of Berlex Laboratories.
"The antiandrogenic property of drospirenone means that it blocks the male sex hormones that can cause acne," said Ian Thorneycroft, Ph.D., M.D., professor of obstetrics and gynecology at the University of South Alabama. "Therefore, it is not surprising that this combination of hormones in a longer active pill regimen treats severe menstrual issues that women experience as well as acne," he added. Studies show that acne tends to flare up in women just prior to or during menstruation.
The most common side effects in the acne clinical trials include upper respiratory infection, irregular bleeding, headache, nausea, sinusitis, and yeast infection.
YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.
Women who would like to learn more about YAZ should visit yaz-us.com.
drospirenone/20 mcg ethinyl estradiol) to treat moderate acne vulgaris in women who desire an oral contraceptive for birth control. With this decision, YAZ becomes the first and only oral
contraceptive ever approved by the FDA for 3 distinct indications. YAZ received FDA approval as an oral contraceptive in March 2006, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD) in women who desire an oral contraceptive in October 2006.
"This latest regulatory approval underscores the culmination of years of research that confirms the promise of YAZ and the distinctness of our innovative progestin, drospirenone, in delivering benefits that are beyond reliable birth control," said Reinhard Franzen, President and CEO of Berlex Laboratories.
"The antiandrogenic property of drospirenone means that it blocks the male sex hormones that can cause acne," said Ian Thorneycroft, Ph.D., M.D., professor of obstetrics and gynecology at the University of South Alabama. "Therefore, it is not surprising that this combination of hormones in a longer active pill regimen treats severe menstrual issues that women experience as well as acne," he added. Studies show that acne tends to flare up in women just prior to or during menstruation.
The most common side effects in the acne clinical trials include upper respiratory infection, irregular bleeding, headache, nausea, sinusitis, and yeast infection.
YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.
Women who would like to learn more about YAZ should visit yaz-us.com.
posted by Ron King | 12:44 AM
