Ortho Evra (norelgestromin/ ethinyl estradiol) transdermal system. Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)October 2. Summary View. WARNINGS AND PRECAUTIONSThromboembolic Disorders and Other Vascular Problemsedited.. The risk of VTE is highest during the first year of use of CHCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to CHCs gradually disappears after CHC use is discontinued. July 2. 01. 1Summary View. ADVERSE REACTIONSPostmarketing Experience. Possible side effects of Ortho Evra patch: All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome. Find patient medical information for Ortho Evra transdermal on. This may increase the risk for blood clots or other side effects from the patch. Infrequent side effects of Ortho Evra transdermal: Change in Curvature of the Eye Severe; High Blood Pressure Severe; Acne Less Severe; Discharge from the Vagina Less Severe; Mood Changes Less Severe; Painful Periods Less. PATIENT PACKAGE INSERTOther Side Effects. March 2. 01. 1Summary View. BOXED WARNINGregarding cigarette smoking and the associated risk of serious cardiovascular events has been modified to be consistent with current labeling for combination hormonal contraceptives. Risk of Venous Thromboembolism (moved from Warnings)The risk of venous thromboembolism (VTE) among women aged 1. Ortho Evra patch compared to women who used oral contraceptives containing 3. EE) and either levonorgestrel or norgestimate was assessed in four U. S. The odds ratios ranged from 1. VTE for current users of Ortho evra April 2. Summary View. WARNINGSTable 5: Estimates (Odds Ratios) of Venous Thromboembolism Risk in Current Users of Ortho Evra Compared to Oral Contraceptive Users. The revision is based on an additional 2. Ingenix Study and data from a new post- marketing study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP). The additional data from the i.
Ortho Evra (norelgestromin. Other Side Effects.increased appetite. Ingenix Study revises the Odds Ratio for venous thromboembolism risk and the confidence interval around the Odds Ratio reported in Table 5 from 2.
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