Is The FDA Doing Enough About Birth Control Products That Contain Third Generation Or Fourth Generation Progestins And Are Associated With Higher Risks Of Blood Clots
A January 3, 2013 Reuters article, "France may curb use of riskier oral contraceptives", has us thinking about whether the FDA should be doing more on the drug-safety front as regards the popular birth control products YAZ / Yasmin and NuvaRing.
From this recent Reuters article:
An inquiry launched this week by the ANSM health regulator will review prescription practices by doctors, whom it says may be over-prescribing higher-risk third and fourth-generation pills.
While all oral contraceptives are associated with a risk of blood clots, a number of studies suggest the most recent brands, known as third and fourth-generation pills, carry a higher risk than their predecessors.
The European Medicines Agency says the risk of an embolism, or blood clot, is twice as high for women using third and fourth-generation pills than for those using earlier versions, although it remains low. The risk of a stroke is the same.
On Wednesday, France's health ministry said it would stop reimbursing prescription costs of third-generation pills from March 31, bringing forward a cut-off date from Sept. 30.
The moves comes weeks after Marion Larat, 25, sued Germany's Bayer and a French official over a stroke she suffered following use of the third-generation contraceptive pill Meliane.
An inquiry found that her use of the pill could have been responsible for her stroke, which led to partial paralysis. Larat's lawyers argue that Bayer should have withdrawn its pill from the market.
While Meliane (gestodene 75 mcg, ethinylestradiol 20 mcg) is not available in the U.S., these relatively "new" contraceptive methods are:
- The birth control pills YAZ, Yasmin, Beyaz, Safyral, Ocella, and Gianvi (as well as the lesser known Zarah, Loryna, Syeda, and Vestura), all of which contain drospirenone (DRSP), considered to be a fourth-generation progestin (also known as progesterone); and,
- NuvaRing, a vaginal ring used for birth control that contains ethinyl estradiol and etonogestrel, a metabolite of desogestrel; the third-generation class of progestins includes desogestrel, gestodene, and norgestimate.
In comparison, most older oral contraceptives use the second-generation class of progestins, which includes levonorgestrel and norgestrel.
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As regards the birth control pills containing DRSP, such as YAZ, Yasmin, Beyaz, Safyral, Ocella, and Gianvi, here is an article about how the medical researchers have found that drospirenone (DRSP) can increase the risk of developing a deep vein thrombosis (DVT) and/or pulmonary embolism (PE): "Two More Medical Studies Show Increased Risk Of Blood Clots With Use Of YAZ, Yasmin, And Ocella".
And, next, here is an article concerning what the FDA has done thus far regarding that increased risk of blood clots that cause DVTs and PEs: "April 2012 Yasmin / YAZ Label Change: FDA Warns About Increased Risk Of Blood Clots Possible Due To Drospirenone".
Now turning to NuvaRing, the following text was extracted from the "WARNINGS, 1. THROMBOEMBOLIC DISORDERS AND OTHER VASCULAR PROBLEMS, a. Thromboembolism" section of the current NuvaRing Prescribing Information, or label, (accessed 1/4/13 at http://www.nuvaring.com) -- which has remained the same since at least August 2007:
Several epidemiology studies indicate that third generation oral contraceptives, including those containing desogestrel (etonogestrel, the progestin in NuvaRing®, is the biologically active metabolite of desogestrel), are associated with a higher risk of venous thromboembolism than certain second generation oral contraceptives. In general, these studies indicate an approximate two-fold increased risk, which corresponds to an additional one to two cases of venous thromboembolism per 10,000 women-years of use. However, data from additional studies have not shown this two-fold increase in risk. It is unknown if NuvaRing® has a different risk of venous thromboembolism than second generation oral contraceptives.
In fact, an FDA study back in 2001 found that the NuvaRing was associated with a significantly higher risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) relative to standard low-dose estrogen birth control pills, as reported in this article: "NuvaRing Update: October 2011 FDA Study Finds Increased Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)".
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Many had hoped that those new study findings about NuvaRing side effects like PE and DVT, as well as strokes and heart attacks, would be presented by the FDA to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting in December 2011.
When I attended the December 9, 2011 FDA advisory committees meeting we heard the tearful parents of a 24-year old woman who had just died on Thanksgiving Day of a massive pulmonary embolism (PE) while using the NuvaRing ask the FDA panelists why the NuvaRing has been allowed to remain on the market despite the many serious blood clot related side effects like PE's, deep vein thrombosis (DVT), and strokes that have been suffered by women and reported to the FDA.
Now, more than a year later, one continues to wonder whether the FDA should be doing more -- especially in view of this action now being taken in Europe -- as regards the persistent and serious drug-safety issues surrounding YAZ / Yasmin and NuvaRing.______________________________________________________________________________