Research
FDA-funded Study: “Increased risk of VTE with the NuvaRing
is new and raises concern”
The objective of this FDA-funded study was to assess cardiovascular risks, including the risk of thrombotic and thromboembolic events and death, for several newly approved products since the early 2000s that had sufficient numbers of users to allow for an evaluation of these risks compared to those associated with use of older, more frequently prescribed contraceptives at the sites selected.
The actual study, which you can read below, concludes with the following remark, “The finding of increased risk of VTE with the ETON (referring to etonogestrel in NuvaRing) vaginal ring relative to standard CHCs is new and raises concern but needs to be replicated in other studies.”
It was recognized at the time that a more in-depth assessment of potential reasons for increased risk would not be possible using only claims and electronic medical records and would require physician and patient contact, something that could be conducted later if needed.
Drug Safety and Availability > FDA-funded Study: Combined Hormonal Contraceptives (CHCs) and the Risk of Thromboembolism and Other Cardiovascular Events
is new and raises concern”
The objective of this FDA-funded study was to assess cardiovascular risks, including the risk of thrombotic and thromboembolic events and death, for several newly approved products since the early 2000s that had sufficient numbers of users to allow for an evaluation of these risks compared to those associated with use of older, more frequently prescribed contraceptives at the sites selected.
The actual study, which you can read below, concludes with the following remark, “The finding of increased risk of VTE with the ETON (referring to etonogestrel in NuvaRing) vaginal ring relative to standard CHCs is new and raises concern but needs to be replicated in other studies.”
It was recognized at the time that a more in-depth assessment of potential reasons for increased risk would not be possible using only claims and electronic medical records and would require physician and patient contact, something that could be conducted later if needed.
Drug Safety and Availability > FDA-funded Study: Combined Hormonal Contraceptives (CHCs) and the Risk of Thromboembolism and Other Cardiovascular Events