FDA study: Newer contraceptives carry higher risks

New may not be better, at least when it comes to hormonal contraception. Safety data released this week not only add to the evidence that birth control pills containing a particular synthetic hormone carry higher-than-previously-thought risks of blood clots, but also raise more questions about other new-generation products, such as contraceptive patches and vaginal rings.

First, a new study of 1.3 million Danish women found that newer pills containing drospirenone, an active ingredient in Bayer's Yaz line of products, were linked to a sixfold increase in dangerous blood clots. Published in the BMJ, the study found that older contraceptives containing levonorgestrel instead of drospirenone had a threefold risk of the clots. As the New York Times reports, however, the journal warned against exaggerating the risk.

That was Tuesday. Yesterday, the FDA issued a communique that expanded the worry beyond Bayer's products. Women using Yaz did have significantly higher rates of blood clots than women using older pills, the agency found in a review of 800,000 American women's medical histories. Women using Johnson & Johnson's patch, Ortho Evra, and Merck's NuvaRing also experienced a higher rate of complications, the FDA said.

The new studies add to the mix of conflicting data on newer contraceptives. The FDA says the latest data will be on the agenda of a Dec. 8 advisory panel meeting convened to discuss hormonal birth control's risks. Bayer has said that the risk of its pills is comparable to that of other hormonal contraceptives. Officials wouldn't comment on the latest data when the NYT asked. We will, however, hear from the company at the advisory panel meeting. For what it's worth, Yaz is Bayer's second-biggest seller.

- read the alert from FDA

- see the NYT piece

- get more from Bloomberg

- check out the AFP story

Related Articles:
FDA turns to advisory panel for Yaz safety analysis
FDA reviews risks of drospirenone contraceptives

Suggested Articles

The FDA has granted Amarin's Vascepa a possible blockbuster label expansion for CV risk reduction in patients with or without CV disease.

In a high-stakes patent lawsuit between CAR-T companies Bristol-Myers Squibb and Gilead Sciences, BMS has come up with a victory. 

It’s been a year of ups and downs for Pfizer’s Xeljanz. But the company is hoping to close on a high note, with help from a new extended-release pill.