May. 17, 2012 at 6:11am
BLOOD CLOTSBMJBRITISH MEDICAL JOURNALDEEP VEIN THROMBOSISFDAFOOD & DRUG ADMINISTRATIONHORMONAL CONTRACEPTIONNUVARINGNUVARING ATTORNEYSNUVARING BLOOD CLOTSNUVARING FDA STUDYNUVARING LAWSUITSNUVARING LAWYERSNUVARING MDLNUVARING RECALLNUVARING SETTLEMENT AMOUNTSNUVARING SETTLEMENTSNUVARING SIDEEFFECTSNUVARING STUDIESNUVARING vs BEYAZNUVARING vs DROSPIRENONENUVARING vs DRSPNUVARING vs GIANVINUVARING vs OCELLANUVARING vs SAFYRALNUVARING vs YASMINNUVARING vs YAZPULMONARY EMBOLIRECALL NUVARINGSTROKES
The #NUVARING is a fairly new option in contraception or birth control. It is not an #IUD which is medically inserted and left in place for 5 or more years at a time. Rather, it is inserted in the vagina and designed to inhibit reproduction by releasing hormones. Hormonal contraceptive pills, or oral contraceptives, release a combination of hormones to inhibit reproduction or prevent pregnancy. In April 2012, the FDA announced that one of the most popular family of oral contraceptives - #YASMIN #YAZ #BEYAZ #SAFYRAL and their generic equivalents #GIANVI #OCELLA #ZARAH #SYEDA - would carry warnings of increased risk of blood clots. A month later, the British Medical Journal released the findings of a new study that evaluated similar risks from use of #NUVARING. The study entitled, “VENOUS THROMBOSIS IN USERS OF NON-HORMONAL CONTRACEPTION: FOLLOW UP STUDY, DENMARK 2001-10”, by O. Lidegaard, L. Hougaard, C. Wessel Skovlund and E. Lokkegaard, analyzed data to conclude that “[w]omen who use combined hormonal transdermal patches or vaginal rings for contraception have a 7.9 times or 6.5 times increased risk of venous thrombosis compared with non-users of hormonal contraception of the same age”. The authors further concluded that, “the vaginal ring conferred 90% higher risk of venous thrombosis than did combined oral contraceptives containing levonorgestrel, bringing the risk to the same level as that of combined oral contraceptives with third and fourth generation” progestins. This was interpreted as confirming the October 2011 findings of an FDA funded study evaluating the vaginal ring and #DROSPIRENONE (#DRSP) containing birth control. They concluded that women who wanted to use a hormonal contraceptive should be advised to use combined oral contraceptives with levonorgestrel or norgestimate, rather than transdermal patches or vaginal rings. Vaginal rings, like #NUVARING, increased the risk of venous thrombosis 6.5 times compared with non-use of hormonal contraception. Whether this study, and FDA’s study of October 2011, will prompt additional investigations, warnings or a #recall remains to be seen. At the time, in October 2011, the FDA admitted that with regard to both #DROSPIRENONE and #NUVARING there was little data available for adverse outcomes. Is that comforting to you? With regard the NUVARING, the FDA noted that the increase risk of blood clots was “new” and raised concerns that needed to be replicated in other studies. From my reading, the BMJ study further underscores concerns and may hopefully prompt some regulatory action. Ironically, the BMJ study was released just before National Women’s Health Week but neither the FDA, nor news media highlighted the study or similar findings FDA’s own study confirmed in October 2011. Whether women were adequately warned of increased risks prior to use is the question posed by a growing number of lawsuits over use of the #NUVARING. The latest study appears to demonstrate a higher risk, no more benefit and raise questions about what the manufacturer knew and when.  Gabriel F. Zambrano, P.A., is the author and sponsor of this commentary. Gabriel F. Zambrano, P.A., is actively representing victims of #DROSPIRENONE containing birth control pills discussed here. Gabriel F. Zambrano, P.A., is investigating #NUVARING   cases involving blood clots or complications from blood clots including: Strokes, Cardiac Infarct, Deep Vein Thrombosis, Pulmonary Emboli, Arterial Thromboembolic Events and other life altering injuries.

The #NUVARING is a fairly new option in contraception or birth control. It is not an #IUD which is medically inserted and left in place for 5 or more years at a time. Rather, it is inserted in the vagina and designed to inhibit reproduction by releasing hormones. Hormonal contraceptive pills, or oral contraceptives, release a combination of hormones to inhibit reproduction or prevent pregnancy.

In April 2012, the FDA announced that one of the most popular family of oral contraceptives - #YASMIN #YAZ #BEYAZ #SAFYRAL and their generic equivalents #GIANVI #OCELLA #ZARAH #SYEDA - would carry warnings of increased risk of blood clots. A month later, the British Medical Journal released the findings of a new study that evaluated similar risks from use of #NUVARING. The study entitled, “VENOUS THROMBOSIS IN USERS OF NON-HORMONAL CONTRACEPTION: FOLLOW UP STUDY, DENMARK 2001-10”, by O. Lidegaard, L. Hougaard, C. Wessel Skovlund and E. Lokkegaard, analyzed data to conclude that “[w]omen who use combined hormonal transdermal patches or vaginal rings for contraception have a 7.9 times or 6.5 times increased risk of venous thrombosis compared with non-users of hormonal contraception of the same age”. The authors further concluded that, “the vaginal ring conferred 90% higher risk of venous thrombosis than did combined oral contraceptives containing levonorgestrel, bringing the risk to the same level as that of combined oral contraceptives with third and fourth generation” progestins. This was interpreted as confirming the October 2011 findings of an FDA funded study evaluating the vaginal ring and #DROSPIRENONE (#DRSP) containing birth control. They concluded that women who wanted to use a hormonal contraceptive should be advised to use combined oral contraceptives with levonorgestrel or norgestimate, rather than transdermal patches or vaginal rings.

Vaginal rings, like #NUVARING, increased the risk of venous thrombosis 6.5 times compared with non-use of hormonal contraception. Whether this study, and FDA’s study of October 2011, will prompt additional investigations, warnings or a #recall remains to be seen. At the time, in October 2011, the FDA admitted that with regard to both #DROSPIRENONE and #NUVARING there was little data available for adverse outcomes. Is that comforting to you? With regard the NUVARING, the FDA noted that the increase risk of blood clots was “new” and raised concerns that needed to be replicated in other studies. From my reading, the BMJ study further underscores concerns and may hopefully prompt some regulatory action.

Ironically, the BMJ study was released just before National Women’s Health Week but neither the FDA, nor news media highlighted the study or similar findings FDA’s own study confirmed in October 2011. Whether women were adequately warned of increased risks prior to use is the question posed by a growing number of lawsuits over use of the #NUVARING. The latest study appears to demonstrate a higher risk, no more benefit and raise questions about what the manufacturer knew and when. 

Gabriel F. Zambrano, P.A., is the author and sponsor of this commentary. Gabriel F. Zambrano, P.A., is actively representing victims of #DROSPIRENONE containing birth control pills discussed here. Gabriel F. Zambrano, P.A., is investigating #NUVARING   cases involving blood clots or complications from blood clots including: Strokes, Cardiac Infarct, Deep Vein Thrombosis, Pulmonary Emboli, Arterial Thromboembolic Events and other life altering injuries.