New Oral Contraceptive from Bayer Approved by US FDA
The first four-phase oral contraceptive in the United States has been approved by its Food and Drug Administration (FDA). It will become available this summer.
Natazia, produced by Bayer HealthCare Pharmaceuticals, is already approved in Europe under the brand Qlaira. It contains the hormone progestin in different dosages that are taken four times in a 28-day treatment cycle.
Women’s bodies react differently to different hormones. The entry of Natazia will provide an option for women when choosing oral contraceptives.
The FDA said that studies conducted among 1,867 women found Natazia to be effective and that it shares the same side effects as other birth control pills. Such side effects include irregular bleeding, breast tenderness, headaches, nausea and vomiting, increased weight, and acne. Women are also advised not to smoke when taking oral contraceptives as it may increase risk of serious cardiovascular side effects.
The drug also helps reduce excessive menstrual bleeding.