Does Organon's Current NuvaRing Label Have Sufficient Warnings About Risk Of Blood Clots And Related Conditions
(Posted by Tom Lamb at DrugInjuryWatch.com)
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UPDATE: Our Focus Page on NuvaRing has a complete collection of our articles about this birth control device / method as well as selected news reports about NuvaRing.
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In Part One of this series about NuvaRing we looked at some medical information about the so-called "third generation" progestin desogestrel causing a significant increased risk of venous thromboembolism, or serious blood clots; in turn, these blood clots can develop into a pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke (CVA), and myocardial infarction (MI) or heart attack.
That medical information is relevant to the emerging drug safety concerns about NuvaRing because Organon's contraceptive vaginal ring contains a relatively high dose of a similar progestin, etonogestrel, which is a metabolite of desogestrel.
In this part of our series about NuvaRing we review some of the warnings about a woman's risk of developing blood clots found in the current NuvaRing Physician's Insert — more generally called the package insert, or label — in light of the medical information from The New England Journal of Medicine and the consumer advocacy group Public Citizen which is set forth in Part One.
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In their current NuvaRing package insert, or label, Organon seemingly attempts to distance NuvaRing from those safety issues surrounding the third generation combination oral contraceptives (COC) that contain the progestin desogestrel — rather than warn doctors and their patients about the probable increased risk of blood clots associated with its combination contraceptive vaginal ring (CCVR) containing etonogestrel.
In Organon's current NuvaRing package insert, or label, (accessed 8/28/07 at http://www.nuvaring.com) we find the following text:
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.
The above text was extracted from the "WARNINGS, 1. THROMBOEMBOLIC DISORDERS AND OTHER VASCULAR PROBLEMS, a. Thromboembolism" section of Organon’s current NuvaRing label and is intended for doctors; this text in the NuvaRing label may or may not be helpful to doctors when they are deciding whether to prescribe Organon's contraceptive ring to their patients.
The following text — taken from the "PATIENT INFORMATION" section of Organon’s current NuvaRing label — does not, however, seem to provide much if any guidance or warning about the risk of developing blood clots to those women who use (or are deciding whether or not to use) NuvaRing:
The hormones in NuvaRing® may cause changes in your blood clotting system which may allow your blood to clot more easily… The risk of getting blood clots may be greater with the type of progestin in NuvaRing® than with some other progestins in certain low-dose birth control pills. It is unknown if the risk of blood clots is different with NuvaRing® use than with the use of certain birth control pills.
In conclusion — given (1) the current medical information available about how the progestin desogestrel can cause blood clots, possibly leading to death due to a pulmonary embolism, stroke, or heart attack, and (2) knowing that NuvaRing contains a relatively high dose of the progestin etonogestrel, which is a metabolite of desogestrel –- we suggest that the warnings in Organon's current NuvaRing package insert, or label, about a woman's risk of developing blood clots are not sufficient.
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