Nuvaring : Facts & Figures

A NUVARING ETHINYL ESTRADIOL: Facts & Figures ETONOGESTREL WHAT IS NUVARING? NuvaRing is a flexible, transparent plastic ring that is inserted in the vagina to prevent pregnancy. Over the course of three weeks, NuvaRing releases a continuous low dose of the hormones estrogen and progestin to prevent ovulation from occurring. MANUFACTURER FDA APPROVAL MSD OSS B.V. (Organon, a subsidiary of Merck & Co., Inc.) The U.S. Food and Drug Administration (FDA) approved NuvaRing for contraceptive use in 2001 MSD FDA STUDY SHINES LIGHT ON NUVARING A Danish study published online by the British Medical Journal in May 2012 found that vaginal ring contraceptives actually led to a "90% higher risk of venuous thrombosis" than did certain combined oral contraceptives. Deep vein thrombosis (DVT) is a type of blood clot that can lead to pulmonary embolism (PE, or a deadly blockage of an artery in a lung), stroke or heart attack. NUVARING RISKS The manufacturer's website lists the following ʻrisks' of NuvaRing use: BLOOD CLOTS STROKES & HEART ATTACKS HIGH BLOOD PRESSURE & HEART DISEASE CANCER OF THE REPRODUCTIVE ORGANS & BREAST GALLBLADDER DISEASE LIVER TUMORS LIPID METABOLISM & INFLAMMATION OF THE PANCREAS ADVERSE EVENT REPORTS Adverse event reports received by the FDA through August 27, 2012 in which NuvaRing was the primary suspect in causing the event included: SIDE EFFECT REPORTS PULMONARY EMBOLISM | 1,040 DEEP VEIN THROMBOSIS | 718 TOTAL ADVERSE METRORRHAGIA| 594 EVENT REPORTS 5,440 HEADACHE 445 NAUSEA 354 TOTAL PRIMARY SUSPECT REPORTS 4,974 HEALTH OUTCOMES Based on adverse event reports received by the FDA through August 27, 2012 with NuvaRing as the primary suspect: REPORTS I SIDE EFFECT 1,586 I OTHER 1,513 I HOSPITALIZATION 280 I LIFE-THREATENING 238 I DISABILITY 76 I DEATH 61I REQUIRED INTERVENTION 17 CONGENITAL ANOMALY A REPORT NUVARING SIDE EFFECTS A Report negative NuvaRing side effects to the FDA at its MedWatch reporting site or by calling (800) FDA-1088 Disclaimer Sources This information is provided for educational purposes only and is not intended to serve as medical or legal advice. Neither The Driscoll Firm, P.C., nor Consultwebs.com, Ic., assumes responsibility for any healthcare decisions or treatment based on the information that is provided herein. Any patient concerned about the side effects of a drug, medical device or medical product should not discontinue or alter use of the drug, device or product in any manner without first consulting with their doctor. AdverseEvents.com British Medical Journal NuvaRing A NUVARING ETHINYL ESTRADIOL: Facts & Figures ETONOGESTREL WHAT IS NUVARING? NuvaRing is a flexible, transparent plastic ring that is inserted in the vagina to prevent pregnancy. Over the course of three weeks, NuvaRing releases a continuous low dose of the hormones estrogen and progestin to prevent ovulation from occurring. MANUFACTURER FDA APPROVAL MSD OSS B.V. (Organon, a subsidiary of Merck & Co., Inc.) The U.S. Food and Drug Administration (FDA) approved NuvaRing for contraceptive use in 2001 MSD FDA STUDY SHINES LIGHT ON NUVARING A Danish study published online by the British Medical Journal in May 2012 found that vaginal ring contraceptives actually led to a "90% higher risk of venuous thrombosis" than did certain combined oral contraceptives. Deep vein thrombosis (DVT) is a type of blood clot that can lead to pulmonary embolism (PE, or a deadly blockage of an artery in a lung), stroke or heart attack. NUVARING RISKS The manufacturer's website lists the following ʻrisks' of NuvaRing use: BLOOD CLOTS STROKES & HEART ATTACKS HIGH BLOOD PRESSURE & HEART DISEASE CANCER OF THE REPRODUCTIVE ORGANS & BREAST GALLBLADDER DISEASE LIVER TUMORS LIPID METABOLISM & INFLAMMATION OF THE PANCREAS ADVERSE EVENT REPORTS Adverse event reports received by the FDA through August 27, 2012 in which NuvaRing was the primary suspect in causing the event included: SIDE EFFECT REPORTS PULMONARY EMBOLISM | 1,040 DEEP VEIN THROMBOSIS | 718 TOTAL ADVERSE METRORRHAGIA| 594 EVENT REPORTS 5,440 HEADACHE 445 NAUSEA 354 TOTAL PRIMARY SUSPECT REPORTS 4,974 HEALTH OUTCOMES Based on adverse event reports received by the FDA through August 27, 2012 with NuvaRing as the primary suspect: REPORTS I SIDE EFFECT 1,586 I OTHER 1,513 I HOSPITALIZATION 280 I LIFE-THREATENING 238 I DISABILITY 76 I DEATH 61I REQUIRED INTERVENTION 17 CONGENITAL ANOMALY A REPORT NUVARING SIDE EFFECTS A Report negative NuvaRing side effects to the FDA at its MedWatch reporting site or by calling (800) FDA-1088 Disclaimer Sources This information is provided for educational purposes only and is not intended to serve as medical or legal advice. Neither The Driscoll Firm, P.C., nor Consultwebs.com, Ic., assumes responsibility for any healthcare decisions or treatment based on the information that is provided herein. Any patient concerned about the side effects of a drug, medical device or medical product should not discontinue or alter use of the drug, device or product in any manner without first consulting with their doctor. AdverseEvents.com British Medical Journal NuvaRing