And while Bayer won a new indication for Natazia to treat heavy menstrual bleeding from the US Food and Drug Administration (FDA) in March, the advancement was soured by the issuance of a black box warning just a month prior for thromboembolic disorders and other vascular issues.
In other words—blood clots. The latter is always a risk associated with the use of oral contraceptives, although that risk is thought to be minimized through the use of older, first- and second-generation contraceptives.
Third-generation products, such as Yaz and Yasmin, have been linked through some studies with increased risk for blood clots. If the FDA's position on estradiol valerate and estradiol valerate/dienogest (Natazia) is any indication, Bayer's new, fourth-generation oral contraceptive appears to mirror the concerns associated with its predecessor.
In spite of the FDA black box warning, Natazia's indication to treat heavy menstrual bleeding will provide for Bayer an important marketing hook, given the difficulties many women have with heavy periods.
"Heavy menstrual bleeding is a common disorder reported by around three million women of reproductive age each year in the United States," said Pamela A. Cyrus, MD, Vice President and Head of US Medical Affairs, Bayer HealthCare Pharmaceuticals, in a statement published March 14 by PR Newswire. "As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an OC for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition."
In granting the new indication for Natazia, which was originally approved in 2010, the FDA is saying that the benefits of Natazia outweigh those risks outlined in the black box warning.
Such was the case for Yasmin and Yaz too, as it is for all pharmaceuticals the FDA allows onto the market: the assumption that all drugs have side effects, some worse than others. And while absolute safety or lack thereof is not part of the conversation per se, the requirement for a drug's benefits to outweigh the risks remains reason enough for approval.
Previously, Bayer's position has been that the risk for blood clot is no greater with Yasmin and Yaz, than other oral contraceptives on the market. However, a statement from Bayer that accompanied the introduction of Natazia in 2010 referenced "increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, hypertension, ruptured ovarian cyst and uterine leiomyoma."
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That weight gain appears to be common, according to many women weighing in on the subject on the WebMD website.
"I have had major weight gain since I have changed over to this new birth control also," writes one Natazia client. "Not very impressed with this. I am now changing back to my old birth control."
Another: "Weight Gain has been severe on this drug. I also have major aches in the arms, and hands and feet."
"Terrible pill. Felt depressed and angry all month long. Plus gained 10 pounds. Had the worst cramps that I've had in 20 years. Stay away from this pill."