Safety

Ortho-Novum Tablets (norethindrone/ethinyl estradiol) and Modicon 28 Tablets (norethindrone/ethinyl estradiol)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

October 2015

Summary View

WARNINGS

Thromboembolic Disorders and Other Vascular Problems

Thromboembolism

  • edited...The risk of thromboembolic disease associated with oral contraceptives gradually disppears after combined oral contraceptive (COC) use is stopped. VTE risk is highest in the first year of use and when restarting hormonal contraception after a break of four weeks or longer.

Page Last Updated: 11/13/2015
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