VTE Risk in NuvaRing (Updated)
On May 10, 2012, the British Medical Journal published a new follow-up study by Dr. Øjvind Lidegaard entitled “Venous Thrombosis in Users of Non-Oral Hormonal Contraception: Follow-Up Study, Denmark 2001-10.” Øjvind Lidegaard et al., Venous Thrombosis in Users of Non-Oral Hormonal Contraception: Follow-Up Study, Denmark 2001-10, 344 BRIT. MED. J. 2990 (2012), available at http://www.bmj.com/highwire/filestream/583967/field_highwire_article_pdf/0.pdf. The study analyzed the relative risk of venous thrombosis events (VTE) in 1,626,158 women from 2001 to 2010. It concluded that the relative risk of VTE in users of vaginal rings was 6.5 times higher than non-users of hormonal contraception, and 1.9 times higher than users of combined oral contraceptives.
NuvaRing is a vaginal contraceptive product of the kind referenced in this study. It was approved by the Food and Drug Administration (FDA) in 2001, and is composed of two active components: the progestin etonogestrel, and the estrogen ethinyl estradiol. Drug Approval Package: NuvaRing, U.S. FOOD & DRUG ADMIN. (Nov. 8, 2001), available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-187_NuvaRing.cfm.
Dr. Lidegaard’s conclusions are not new as “[a] recent study reported a … higher risk of [VTE] in women using a vaginal ring.” See OFFICE OF SURVEILLANCE & EPIDEMIOLOGY, U.S. FOOD & DRUG ADMIN., CHC-CVD-111022, COMBINED HORMONAL CONTRACEPTIVES (CHCS) AND THE RISK OF CARDIOVASCULAR DISEASE ENDPOINTS (2011), available at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf. Dr. Lidegaard’s study, therefore, further clarified the existing statistics linking the NuvaRing to VTE. Taking these statistics in collectively, there is ample evidence demonstrating the potential adverse effects the NuvaRing may have on women.
Rapid responses to Dr. Lidegaard’s article were published by Dr. Samuel Shapiro, Dr. Jane Skov, Dr. Anne Szarewski, Dr. Julie M. Chandler, and Dr. Mary E. Gaffield. Some of these authors have been affiliated with the pharmaceutical industry. It is unclear whether the critics of Dr. Lidegaard’s article reviewed the study or its data in detail prior to posting their “rapid responses,” all of which were posted only days after Dr. Lidegaard’s study was published.
At this time, despite this study, the NuvaRing label states “[i]t is unknown if NuvaRing has a different risk of venous thromboembolism than second generation oral contraceptives.” It is unclear whether the manufacturer of NuvaRing intends to update its label in accordance with this study’s findings in the near future.
Attorneys at Schlichter Bogard & Denton have extensive knowledge in the NuvaRing litigation as they are members of the Multidistrict Litigation (MDL) Executive Committee, and represent clients from around the country. Attorneys at Schlichter Bogard & Denton also represent women in the YAZ birth control pill litigation, and have represented women in the Ortho Evra birth control patch litigation. If you or someone you know has been injured by NuvaRing or any other form of birth control, please contact the attorneys at Schlichter Bogard & Denton to discuss your case.