Bad News for the NuvaRing by Jeffrey Dach MD

NuvaRingcompressed - Bad News for the NuvaRing by Jeffrey Dach MD

Bad News for the NuvaRing

by Jeffrey Dach MD

Lately, we have seen a growing number of young women using the NuvaRing, reporting anxiety, depression, insomnia, headache, and other symptoms.  The NuvaRing is a contraceptive device containing synthetic hormones, a form of birth control. Above Left Image:  NuvaRing Contraceptive Device .  This device is  impregnated with synthetic hormones that cause blood clots and stroke.  Courtesy of Wikimedia Commons.

Stroke from Synthetic Hormones in Oral Contraceptives, Birth Control Pills

My previous article discussed the adverse effects of synthetic hormones in birth control pills.(1)  One dreaded complication is embolic stroke.  Working in the hospital as an interventional radiologist over the years, one of my jobs was to perform angiograms on young women who had strokes while on birth control pills.  The referring doctors ordered angiograms on these young women to get a look at the cerebral arteries after the fact.

Stroke MCA arrows - Bad News for the NuvaRing by Jeffrey Dach MDLeft Image : CAT Scan of right middle cerebral artery stroke, (red arrows) . This is a cerebrovascular accident due to occlusion of middle cerebral artery.  Green arrow denotes midline shift. This patient was left with a permanent paralysis of the left arm and leg. Courtesy of wikimedia commons.

These unfortunate victims had already recovered from the arterial occlusion and most had recovered function.  However, some  had completed strokes with permanent neurological damage with weakness or paralysis of an upper of lower extremity.(see above image of CAT scan)

Seeing these young women with residual stroke  created an incongruous image in my mind which I cannot forget,  the image of  an otherwise youthful and healthy young women, a mother or college student, holding an debilitated, paralyzed arm at her side.  After seeing a number of these victims, I must admit I developed an unease and discomfort with a mainstream medical system that creates such victims as an acceptable risk of doing business.

Stroke from the Nuva-Ring

The older birth control pill has been supplanted by the newer Nuva-Ring which is another method to deliver synthetic hormones into the female body to prevent pregnancy.  The  Nuva-Ring increases the risk of blood clot formation, stroke and heart attack.  A recent 2012 NEJM study which showed a 300% increased risk of stroke and heart attack in Nuva Ring users compared to placebo.(2)  This is not good, and such negative findings are usually the death knell for the drug which ends up banned or at least a Black Box warning.  None of this has happened yet for the Nuva Ring.

FDA Adverse Reporting System

My previous article dealt with warning signs that let you know you are dealing with a bad drug.  One of these is to take a look at the FDA adverse reporting system, to see numbers and types of adverse events. (3,4,5) (8)

As of  Sep 3, 2012: 8,418 people reported side effects from the Nuvaring.(5)

(1) Deep vein thrombosis : 3,434 reports.
(2) Pulmonary embolism : 2,467 reports.
(3) Anxiety : 1,387 reports. and is moderate
(4) Metrorrhagia : 1,253 reports.
(5) Headache : 829 reports.
(6) Depression: 652 reports.
(7) Nausea : 646 reports.
(8) Migraine: 633 reports. It’s more common among females aged 20-29 years old, and can be severe
(9) Thrombosis : 549 reports.
(10) Hypercoagulation : 483 reports.
(11) insomnia

Bad Drug Litigation – NuvaRing

Another warning sign you might be dealing with a “bad drug” is the number of people with legal cases in drug litigation.  (6,7)  There are about a thousand women claiming in court that the Nuva-Ring caused their stroke, heart attack or death. (6,7)  This is not a good sign.

Update Jan 2014: Article in Vanity Fair

In Vanity Fair Magazine: Danger in the Ring By Marie Brenner

“When 24-year-old Erika Langhart—talented, beautiful, bound for law school—died on Thanksgiving Day 2011, she became one of thousands of suspected victims of the birth-control device NuvaRing. Elite army athlete Megan Henry, who survived rampant blood clots in her 20s, is another. With major suits against NuvaRing’s manufacturer, Merck, headed for trial, Marie Brenner asks why, despite evidence of serious risk, a potentially lethal contraceptive remains on the market.” excerpt from article

What is the Alternative to the Nuva-Ring? 

The Copper T – IUD.

For women who want some form of birth control to avoid pregnancy, a healthier non-hormonal option is the Copper T- IUD from Paragard.  This is now recommended by the American College of OB/Gyn for women of all child bearing ages.  The Copper T IUD is safer and more effective, and less costly than the traditional Oral Contraceptive Pill, as was discussed in my previous article.  The Copper T- IUD is vastly safer than the Nuva-Ring, since the Copper T – IUD is Non-Hormonal, meaning it does not contain the synthetic hormones that cause stroke, heart attack and death.

The Safety of Trans-Dermal Bioidentical Estrogen

The blood clotting effects of synthetic hormones pills are well known. However, the use of transdermal bioidentical estrogen is safe and not associated with blood clot formation.  These medical studies are discussed  in my previous two articles listed here:

The Safety of Transdermal Estrogen Part one

The Safety of Transdermal Estrogen Part Two

Articles with Related Interest:

Adverse Effects of Birth Control Pills

Protect Your Family From Bad Drugs

Author/: Jeffrey Dach MD

Links and References

1) Adverse effects of Birth Control Pills

Nuvaring Stroke and MI

2) www.nejm.org/doi/full/10.1056/NEJMoa1111840?query=featured_home

N Engl J Med. 2012 Jun 14;366(24):2257-66.  Thrombotic stroke and myocardial infarction with hormonal contraception. Lidegaard Ø, Løkkegaard E, Jensen A, Skovlund CW, Keiding N. Source Gynecologic Clinic 4232, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

BACKGROUND:Although several studies have assessed the risk of venous thromboembolism with newer hormonal contraception, few have examined thrombotic stroke and myocardial infarction, and results have been conflicting. METHODS: In this 15-year Danish historical cohort study, we followed nonpregnant women, 15 to 49 years old, with no history of cardiovascular disease or cancer. Data on use of hormonal contraception, clinical end points, and potential confounders were obtained from four national registries.

RESULTS: A total of 1,626,158 women contributed 14,251,063 person-years of observation, during which 3311 thrombotic strokes (21.4 per 100,000 person-years) and 1725 myocardial infarctions (10.1 per 100,000 person-years) occurred. As compared with nonuse, current use of oral contraceptives that included ethinyl estradiol at a dose of 30 to 40 μg was associated with the following relative risks (and 95% confidence intervals) for thrombotic stroke and myocardial infarction, according to progestin type: norethindrone, 2.2 (1.5 to 3.2) and 2.3 (1.3 to 3.9); levonorgestrel, 1.7 (1.4 to 2.0) and 2.0 (1.6 to 2.5); norgestimate, 1.5 (1.2 to 1.9) and 1.3 (0.9 to 1.9); desogestrel, 2.2 (1.8 to 2.7) and 2.1 (1.5 to 2.8); gestodene, 1.8 (1.6 to 2.0) and 1.9 (1.6 to 2.3); and drospirenone, 1.6 (1.2 to 2.2) and 1.7 (1.0 to 2.6), respectively. With ethinyl estradiol at a dose of 20 μg, the corresponding relative risks according to progestin type were as follows: desogestrel, 1.5 (1.3 to 1.9) and 1.6 (1.1 to 2.1); gestodene, 1.7 (1.4 to 2.1) and 1.2 (0.8 to 1.9); and drospirenone, 0.9 (0.2 to 3.5) and 0.0. For transdermal patches, the corresponding relative risks were 3.2 (0.8 to 12.6) and 0.0, and for a vaginal ring, 2.5 (1.4 to 4.4) and 2.1 (0.7 to 6.5).
CONCLUSIONS: Although the absolute risks of thrombotic stroke and myocardial infarction associated with the use of hormonal contraception were low, the risk was increased by a factor of 0.9 to 1.7 with oral contraceptives that included ethinyl estradiol at a dose of 20 μg and by a factor of 1.3 to 2.3 with those that included ethinyl estradiol at a dose of 30 to 40 μg, with relatively small differences in risk according to progestin type. (Funded by the Danish Heart Association.).

Adverse Reporting System FDA

3) www.druginformer.com/search/side_effect/nuvaring
NuvaRing- 32,039 events reported to the FDA adverse drug reporting system

4)  deleted

5) Nuvaring side effects and drug interactions.

NuvaRing Lawsuits

6) news.yahoo.com/study-finds-increased-risk-nuvaring-stroke-heart-attack-002618487.html

New Study Finds Increased Risk Of NuvaRing Stroke and Heart Attack Merck & Co., the manufacturer of NuvaRing, is currently defending over 950 NuvaRing lawsuits. Plaintiffs in the lawsuits allege that the company sold a defectively designed product and failed to adequately warn users of the increased risk of NuvaRing adverse effects, such as stroke and heart attack. The majority of these cases are pending in a federal multidistrict litigation in the U.S. District Court for the Eastern District of Missouri before Judge Rodney Sippel (MDL No. 1964), and in a coordinated proceeding in Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti (Docket No. BER-L-3081-09).

7) www.prweb.com/releases/prwebnuvaring-claim/nuvaring-lawsuits/prweb9821653.htm Experts Warn of NuvaRing Blood Clot Side Effects T

PRWEB/// August 22, 2012

The NuvaRing Resource Center, a patient advocacy group, is alerting women who used the contraceptive NuvaRing that the device has been linked to increased risks of blood clots and related injuries. Lawyers are currently helping those affected determine their legal options. Anyone who suffered a blood clot, DVT, stroke or Pulmonary Embolism after using NuvaRing is urged to contact the NuvaRing Resource Center or speak with a lawyer about their legal options.

NuvaRing is a once-a-month vaginal ring contraceptive which Merck marketed as containing lower doses of hormones. However, the device releases chemicals directly into the bloodstream on a constant basis.

So far, the FDA has received over 1,000 reports of blood clot injury or death in patients using NuvaRing.

On October 27, 2011 they released a report titled, “Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints”, which showed vaginal ring contraceptives could increase the risks of blood clots by as much as 56% over traditional birth control pills.

The British Medical Journal published a study from Denmark on May 10, 2012 linking vaginal rings like NuvaRing to as much as a 90% increased risk of blood clots over oral contraceptives.

On June 14, 2012, the New England Journal of Medicine also published a Danish study finding vaginal ring contraceptives could relate to a 2.5 to 3-fold increased risk of blood clots. Due to the large number of NuvaRing lawsuits filed by patients, the cases have been consolidated into a federal Multi-District Litigation court in Missouri. The formal case is known as In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri. So far, nearly 1,000 victims have filed a NuvaRing claim. The NuvaRing Resource Center urges anyone affected by blood clots, stroke, DVT or pulmonary embolism after using NuvaRing to learn their legal rights as soon as possible. Victims should make sure they choose a lawyer with experience in defective drug litigation. The Resource Center only recommends lawyers and law firms who have already handled NuvaRing lawsuits.

8) www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf
Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints FDA Office of Surveillance and Epidemiology, Lead Site Rita Ouellet-Hellstrom, Ph.D., M.P.H., FDA Principal Investigator David J. Graham, M.D., M.P.H., FDA Senior Science Advisor Judy A. Staffa, Ph.D., R.Ph., FDA Project Officer

More references:

1. Cardiovascular disease and steroid hormone contraception. Technical Report Series: WHO1998

2. Chan WS, Ray J, Wai EK, Ginsburg S, Hannah ME, Corey PN, Ginsberg JS.
Risk of stroke in women exposed to low-dose oral contraceptives: a critical evaluation of the evidence. Arch Intern Med. 2004 Apr 12;164(7):741-7

3. Baillargeon JP, McClish DK, Essah PA, Nestler JE.
Association between the current use of low-dose oral contraceptives and cardiovascular arterial disease: a metaanalysis. J Clin Endocrinol Metab. 2005 Jul;90(7):3863-70. Epub 2005 Apr 6.

4. Dinger JC, Heinemann LA, Kühl-Habich D.
The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception. 2007 May;75(5):344-54. Epub 2007 Feb 23

5. Dinger J, Assmann A, Möhner S, Minh TD.
Risk of venous thromboembolism and the use of dienogest- and drospirenone-containing oral contraceptives: results from a German case-control study. J Fam Plann Reprod Health Care. 2010 Jul;36(3):123-9.

6. Seeger JD, Loughlin J, Eng PM, Clifford CR, Cutone J, Walker AM.
Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstet Gynecol. 2007 Sep;110(3):587-93.

7. Lidegaard Ø, Løkkegaard E, Svendsen AL, Agger C.
Hormonal contraception and risk of venous thromboembolism: national follow-up study.
BMJ. 2009 Aug 13;339:2890. doi: 10.1136/bmj.b28

8. van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP, Doggen CJ, Rosendaal FR.
The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. B
MJ. 2009 Aug 13;339:b2921. doi: 10.1136/bmj.b2921.

9. Parkin L, Sharples K, Hernandez RK, Jick SS.
Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ. 2011 Apr 21;342:d2139. doi: 10.1136/bmj.d2139.

10. Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral    contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ. 2011 Apr 21;342:d2151.

11. Jick SS, Kaye JA, Russmann S,
Jick H. Risk of non-fatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 µg if ethinyl estradiol. Contraception. 2006 73: 223-228.

12. Jick S, Kaye JA, Li L, Jick H.
Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 micrograms of ethinyl estradiol. Contraception. 2007 Jul;76(1):4-7. Epub 2007 May 11.

13. Jick SS, Hagberg KW, Kaye JA.
ORTHO EVRA and venous thromboembolism: an update. Contraception. 2010 May;81(5):452-3. Epub 2010 Jan 27. No abstract available.

14. Jick SS, Hagberg KW, Hernandez RK, Kaye JA.
Postmarketing study of ORTHO EVRA and levonorgestrel oral contraceptives containing hormonal contraceptives with 30 mcg of ethinyl estradiol in relation to nonfatal venous thromboembolism. Contraception. 2010 Jan;81(1):16-21. Epub.

15. Jick SS, Jick H.
The contraceptive patch in relation to ischemic stroke and acute myocardial infarction.
Pharmacotherapy. 2007 Feb;27(2):218-20.

16. Cole JA, Norman H, Doherty M, Walker AM.
Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users.
Obstetrics and Gynecologist . 2007 Feb;109(2):339-346.

17. Dore DD, Norman H, Loughlin J, Seeger JD.
Extended case-control study results on thromboembolic outcomes among transdermal contraceptive users.
Contraception. 2010 May;81(5):408-13. Epub 2010 Jan 22.

18. Heinemann LAJ, Dinger JC.
Range of published estimates of venous thromboembolism incidence in young women.
Contraception 75:328-336, 2007.

19. Petitti DB, Sidney S, Quesenberry CP Jr, Bernstein A.
Incidence of stroke and myocardial infarction in women of reproductive age.
Stroke. 1997 Feb;28(2):280-3.

20. Ducros E, Berthaut A, Mirshahi SS, Faussat AM, Soria J, Agarwal MK, Mirshahi M.
Aldosterone modifies hemostasis via upregulation of the protein-C receptor in human vascular endothelium.  Biochem Biophys Res Commun. 2008 Aug 22;373(2):192-6    33

21 ) http://www.huffingtonpost.com/2013/12/18/nuvaring-blood-clots_n_4461429.html
Side Effects May Include Death: The Story Of The Biggest Advance In Birth Control Since The Pill  Sabrina Siddiqui

22)  http://www.nuvaringsafety.com/news-and-advice.html

Jeffrey Dach MD
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NuvaRingcompressed - Bad News for the NuvaRing by Jeffrey Dach MD
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Bad News for the NuvaRing by Jeffrey Dach MD
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Adverse health effects of synthetic hormones in the NuvaRing device.
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