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A fourth-generation oral contraceptive introduced by Bayer in 2010, Natazia succeeds Yaz, or Yasmin, both in composition and concept. Both drugs use a combination of synthetic hormones to prevent pregnancy and have been approved to control heavy menstrual bleeding.
But, while Natazia is relatively new to the market, it carries the same risks as Yaz, including thromboembolic events and other vascular issues, which could prove deadly without adequate treatment.
Background
In the 2000s, Yaz became one of the top-selling birth control pills in the U.S., originally approved for preventing pregnancy but further advertised for controlling heavy bleeding and moderate acne. Yet, patients who experienced life-threatening blood clots and deep vein thrombosis (DVT) started coming forward, and as a result, Yaz and its other forms became the subject of multiple lawsuits.
When this occurred, Bayer’s profits dropped about 15 percent in a year, and the company, perhaps in response, introduced Natazia, first sold in Europe under name Qlaira in 2009. By 2010, the FDA approved this drug, a combination that releases hormones estradiol valerate and dienogest with progestin to prevent pregnancy. Two years later, the FDA then approved it for controlling heavy menstrual bleeding not related to diagnosed uterine conditions.
Unlike Yaz, Natazia uses a different dosing regimen, one in which women take four different hormonal or sugar pill combinations each month. But, with its introduction, Bayer warned about increased risks of several life-threatening conditions, including:
- Venous and arterial thrombotic and thromboembolic events, such as myocardial infarction, thromboembolism, or a stroke
- Hepatic neoplasia
- Gallbladder disease
- Hypertension
- Ruptured ovarian cysts
- Uterine Leiomyoma
Risks of thromboembolic events are at their highest during the first year.
In response, the FDA required Bayer to update Natazia in 2012 with a black box warning for thromboembolic disorders and vascular issues. The decision came after a study of various combined oral contraceptives, or COCs, which indicated that risks for both conditions are at their greatest during the first six months, particularly when a patient starts taking the drug or restarts after a four week or longer break.
Lawsuits
While patients have yet to come forward with lawsuits concerning Natazia and other COCs, this drug carries the same risks and side effects as its predecessor, Yaz. If you’ve experienced a life-threatening blood clot after taking Natazia, the manufacturer must be held accountable for its negligence and placing profits over patients’ safety.
