Bayer AG’s new birth control pill Natazia, a combination hormonal contraceptive tablet containing estradiol valerate and dienogest received the approval of the US Food and Drug Administration (FDA) Thursday.
The new pill offers four progestin/estrogen dosing combinations during each 28-day cycle, and is the first contraceptive containing contain the bio-identical synthetic estrogen estradiol valerate, rather than ethinyl estradiol.
Already, licensed in Europe and selling under the brand name Qlaira, FDA said Natazia is also the first four-phase oral contraceptive to be marketed in the USA.
Dr. Scott Monroe of the federal agency said, currently, around 12 million women in the USA and over 100 million women worldwide use oral contraceptives, with the approval of Natazia providing another option for women opting for oral contraceptives, as their method of contraception.
According to FDA, two studies of 1,867 women found Natazia to be effective, including having many of the same side effects as other birth control pills.
Adverse events most commonly (2%) reported with estradiol valerate/dienogest use included headache, including migraines (13.2%); metrorrhagia and irregular menstruation (8.0%); breast pain, discomfort, or tenderness (6.6%); nausea/vomiting (6.5%); acne (3.9%); and weight gain (2.8%).
In October, Bayer reported the drug could also reduce excessive menstrual bleeding.
But, as with other oral contraceptives, estradiol valerate/dienogest’s safety labelling strongly advises women should not smoke, as it would only increase the risk for serious cardiovascular events, which increase with age and the number of cigarettes smoked, particularly for those 35 plus.