UPDATED: Here is the Merck spokeperson's perspective -- at the same article's source code:
". . . .All combined hormonal contraceptives, including NuVaRing and combined oral contraceptives, are associated with an increased risk of [VTE]," said [Merck spokeswoman] Keller. A VTE is a "venous thromboembolic event," which Keller says includes "deep vein thrombosis and pulmonary embolism."
She cited a company study and a U.S. Food & Drug Administration (FDA) study she says "found that the risk of blood clots for new users of NuVaRing is similar to the risk for new users of" combined oral contraceptives.
She also said "all [combined hormonal contraceptives], including NuVaRing, have a Boxed Warning on the increased risk of serious cardiovascular events." She pointed to how "the FDA-approved patient information and the physician package labeling for NuVaRing" have provided such information "since the product was approved in 2001." Keller says updates were made in October 2013 to account for how NuVaRing's new users are at "similar ... risk [of blood clots]" as "new users of combined oral contraceptives."
In a previous e-mail correspondence, Merck spokesperson Keller did tell LifeSiteNews that out of 10,000 women who might take NuVaRing and are not on "combined hormonal contraceptives" (CHC), a year later "1 to 5 of these women will develop a VTE. . . ."
She also told LifeSiteNews that "if 10,000 women who use a CHC" do so in addition to using NuVaRing, "3 to 12 women will develop a VTE." Women at highest risk are those "who are postpartum," meaning 12 weeks past delivery. Of 10,000 women, "40 to 65 will develop a VTE" in one year. . . ..
I'll be back much later tonight; fun road trips beckon me northward.
No comments:
Post a Comment