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U.S. Department of Health and Human Services

Safety

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Birth Control Pills Labeling Updates October 2013

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

including:

  • Modicon (norethindrone/ethinyl estradiol)
  • Ortho Novum (norethindrone/ethinyl estradiol)
  • Ortho-Cyclen (norgestimate/ethinyl estradiol)
  • Ortho Tri-Cyclen (norgestimate/ethinyl estradiol)
  • Ortho-Cept (desogestrel/ethinyl estradiol)

 

 

October 2013

Summary View

BOXED WARNING

WARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING

  • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including ORTHO-NOVUM and MODICON, ORTHO TRI-CYCLEN and ORTHO-CYCLEN, and Ortho-Cept should not be used by women who are over 35 years of age and smoke.

CONTRAINDICATIONS

  • Persistent blood pressure values of greater than 160 mm Hg systolic or greater than 100 mg Hg diastolic
  • the addition of thrombophilic conditions as contraindications

WARNINGS

Elevated Blood Pressure
  • Women with a history of hypertension or hypertension-related diseases, or renal disease70 should be encouraged to use another method of contraception. If these women elect to use oral contraceptives, they should be monitored closely and if a clinically significant persistent elevation of blood pressure (BP) occurs (greater than 160 mm Hg systolic or greater than 100 mm Hg diastolic) and cannot be adequately controlled, oral contraceptives should be discontinued. In general, women who develop hypertension during hormonal contraceptive therapy should be switched to a non-hormonal contraceptive. If other contraceptive...

PRECAUTIONS

Drug Interactions subsection
  • The changes update these sections to be consistent with labeling of Ortho Evra