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Merck Updates Black Box Warning for NuvaRing


August 6, 2014 — The “Black Box” warning information for NuvaRing has been updated in Canada and the United States.

NuvaRing, a popular O-shaped contraceptive device manufactured by Merck & Co., should not be used by women over the age of 35 who smoke cigarettes or have one of the following serious medical conditions:

  • Heart disease
  • High blood pressure
  • Abnormal blood-fat levels
  • Blood clotting disorders
  • Diabetes
  • Major surgery with prolonged immobilization
  • Migraines with focal neurological symptoms
  • Pancreatitis associated with high triglyceride levels

Merck issued a Safety Advisory in Canada but did not make an announcement in the United States.

According to the advisory, NuvaRing has also been linked to additional side effects, including systemic lupus erythematosus, Sydenham’s chorea, herpes gestationis, otosclerosis-related hearing loss, hepatocellular carcinoma, Crohn’s disease, colitis ulcerosa and angioedema.

About 3,800 women in the United States have filed lawsuits against Merck for failing to warn about the risk of blood clots from NuvaRing. Many of the lawsuit were filed after a study, published in 2012 by the British Medical Journal, linked NuvaRing to a doubled risk of blood clots compared to women on birth control with the hormone levonorgestrel.

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