ST LOUIS (MD Consult) - On May 6, 2010, the US Food and Drug Administration (FDA) and Bayer HealthCare Pharmaceuticals announced the approval of Natazia (estradiol valerate and estradiol valerate/dienogest) tablets for the prevention of pregnancy. According to Anita Nelson, MD, professor of obstetrics and gynecology at the Harbor-UCLA Medical Center in Torrance, Calif, "Every woman's body reacts differently to hormones, so it is important that they have a choice in birth control options. Natazia may be a good option for women to consider when making a decision with their health care provider about which birth control option is right for them."
An FDA press release states that Natazia is the first four-phasic oral contraceptive approved for marketing in the United States. Four-phasic refers to the doses of progestin and estrogen varying at 4 times throughout each 28-day treatment cycle. Another difference between Natazia and previously marketed combination oral contraceptives (COCs) is that it contains estradiol valerate instead of ethinyl estradiol as the estrogen component.
The safety and efficacy of Natazia as an oral contraceptive agent was evaluated in 2 multicenter phase 3 clinical trials in North America and Europe involving 1,867 women and almost 30,000 28-day treatment cycles. Natazia was found to be effective as a hormonal contraceptive in both studies.
The most common adverse effects observed with Natazia include irregular bleeding, breast tenderness, headaches, nausea, vomiting, increased weight, and acne.
Natazia should not be used in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal genital bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant), or liver disease. The use of Natazia is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (including myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, hypertension, ruptured ovarian cysts, and uterine leiomyoma. The excess risk of thromboembolic events is highest during the first year of COC use.
Women using COCs, including Natazia, should be strongly advised not to smoke. Smoking increases the risk of serious cardiovascular untoward effects from COC use. The risk increases with age and the number of cigarettes smoked.
Natazia has not been evaluated in women with a body mass index >30 kg/m2.
