28 junio, 2013

Antidepressant Gets FDA OK for Hot Flashes

- Menopause is not a disease. Is a normal step in a woman life.
- Paroxetin is an antidepressive drug, with many adverse effects.
- Another bussines in the FDA.

The FDA has approved paroxetine (Brisdelle), a selective serotonin reuptake inhibitor (SSRI), to treat moderate to severe hot flashes associated with menopause.
"Today's approval provides women with the first FDA-approved, nonhormonal therapeutic option to help ease the hot flashes that are so common in menopause," said Hylton Joffe, MD, director of the division of bone, reproductive, and urologic products at the FDA's Center for Drug Evaluation and Research.
The safety and efficacy of the drug in this condition was established in two randomized, double-blind, controlled studies in 1,175 postmenopausal women with moderate to severe hot flashes.
Women in the study had a minimum of seven to eight hot flashes per day or 50 to 60 per week.
Treatment lasted 12 weeks in one study and 24 weeks in another, and both trials showed that paroxetine reduced hot flashes better than placebo.
The most common side effects with the drug included headache, fatigue, and nausea or vomiting,
The dosage approved for use in hot flashes (7.5 mg) is far lower than that used in conditions such as major depressive disorder, obsessive-compulsive disorder, panic disorder, and generalized anxiety disorder.
Still, the medication will contain a boxed warning about suicidality given that this side effect is included in the label for the drug when it is used in higher doses in the other conditions.
Additional warnings that will be included in the label will note a possible reduction in the efficacy of tamoxifen if both medications are used together, an increased risk of bleeding, and a risk of developing serotonin syndrome – symptoms of which include confusion, rapid heart rate, and high blood pressure.
The drug will be marketed by Noven Therapeutics of Miami.

English: Blood pressure measurement. (Photo credit: Wikipedia)

2006 Aug;48(2):246-53. Epub 2006 Jun 26.

Full Text

Effects of a new hormone therapy, drospirenone and 17-beta-estradiol, in postmenopausal women with hypertension.

White WB, Hanes V, Chauhan V, Pitt B.

Source

Division of Hypertension and Clinical Pharmacology, The Pat and Jim Calhoun Cardiology Center, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030-3940, USA. wwhite@nso1.uchc.edu

Abstract

Drospirenone (DRSP), a progestin with antialdosterone activity, has been developed for hormone therapy in combination with 17-beta-estradiol (E2) in postmenopausal women. We evaluated the antihypertensive efficacy and safety of various doses of DRSP and E2 and estradiol alone in postmenopausal women with hypertension using ambulatory and clinic blood pressure (BP) monitoring. This was a randomized, double-blind clinical trial of 3 doses of DRSP combined with estradiol, estradiol alone, and placebo in 750 postmenopausal women with stage 1 to 2 hypertension between 45 to 75 years. Ambulatory and clinic BPs, potassium, aldosterone, and lipid measurements and adverse events were evaluated in postmenopausal women with stages 1 to 2 hypertension during 8 weeks of double-blind therapy. DRSP and E2 induced dose-related reductions in the ambulatory and clinic systolic BP with physiological increases in serum aldosterone. Significant decreases in 24-hour systolic pressure were observed at doses of 2 and 3 mg of DRSP combined with estradiol but not by estradiol alone or 1 mg of DRSP with estradiol. There were no significant changes from baseline in potassium in any treatment group. Small, significant reductions in total and low-density lipoprotein cholesterol occurred on all of the active treatments, and serum triglycerides did not change. Adverse event rates were low and similar across treatment groups. In conclusion, these data show that DRSP combined with E2 significantly reduces BP in postmenopausal women with hypertension and did not induce significant increases in serum potassium. These characteristics may lead to a new benefit for this novel hormone therapy in postmenopausal women with hypertension.