Drug Safety-related Labeling Changes (SrLC)

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LYBREL (NDA-021864)

(ETHINYL ESTRADIOL; LEVONORGESTREL)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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06/16/2016 (SUPPL-7)

Approved Drug Label (PDF)

5 Warnings and Precautions

Thromboembolic Disorders and Other Vascular Problems

Venous Thrombosis and Thromboembolism (addition of the following paragraph)

  • A post-marketing observational study evaluated the risk of venous thromboembolism with Lybrel use in two large US automated healthcare claims databases. The study was not completed as planned due to low accrual of Lybrel users in these databases and discontinuation of the product from the market due to low usage. At study discontinuation, the crude incidence rate of venous thromboembolism among Lybrel users (n=12,281) was 17.6 per 10,000 person-years, compared to 8.8 per 10,000 person-years among the users of cyclic oral contraceptives containing 20 mcg of ethinyl estradiol and a progestogen, and 5.1 per 10,000 person-years among the users of cyclic oral contraceptives containing the progestin levonorgestrel and 20 mcg of ethinyl estradiol. Adjustment for important risk factors or confounders (such as obesity, cardiovascular disease and other diseases) for venous thromboembolism could not be performed due to the small sample size. Although the study results suggest an elevated risk of venous thromboembolism with current Lybrel use compared to cyclic oral hormonal contraceptive use, reliable interpretation of the results is significantly limited due to the small sample size and concerns over unmeasured and uncontrolled confounding, as well as questions about the suitability of the comparator selection and the validity of the venous thromboembolism definition.

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