A new black box warning will be added to the safety labels of several brands of estrogen-plus-progestin birth control pills urging women who are older than 35 years of age who smoke not to use the medication because it greatly increases their chances of having a heart attack or stroke.
Black box warnings, or boxed warnings, are the strongest warning the Food and Drug Administration (FDA) requires, and signifies that medical studies indicate that using a drug carries a significant risk of serious or even deadly adverse effects.
The warnings will be placed on the following oral contraceptives:
- 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)
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. The risk increases with age, particularly in women older than 35, and with the number of cigarettes smoked. For this reason, combination birth control pills should not be used by women who are older than 35 years of age and smoke, the warning states.
The new labels also advise that the pills should not be used in women with persistent blood pressure values of greater than 160 mm Hg systolic or greater than 100 mg Hg diastolic, nor should it be used in women with known thrombophilic conditions.
The new label warns that women with a history of hypertension or hypertension-related diseases, or renal disease 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 occurs and cannot be adequately controlled, oral contraceptives should be discontinued.