May 28, 2017
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"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...





Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

Noncontraceptive Health Benefits

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on menses

Increased menstrual cycle regularity.

Decreased blood loss and decreased incidence of iron-deficiency anemia.

Decreased incidence of dysmenorrhea.

Effects related to inhibition of ovulation

Decreased incidence of functional ovarian cysts.

Decreased incidence of ectopic pregnancies.

Effects from long-term use

Decreased incidence of fibroadenomas and fibrocystic disease of the breast.

Decreased incidence of acute pelvic inflammatory disease.

Decreased incidence of endometrial cancer.

Decreased incidence of ovarian cancer.


Combination oral contraceptives should not be used in women with any of the following conditions:

Thrombophlebitis or thromboembolic disorders.
A past history of deep-vein thrombophlebitis or thromboembolic disorders.
Cerebral-vascular or coronary artery disease.
Thrombogenic valvulopathies.
Thrombogenic rhythm disorders.
Diabetes with vascular involvement.
Uncontrolled hypertension.
Known or suspected carcinoma of the breast.
Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
Undiagnosed abnormal genital bleeding.
Cholestatic jaundice of pregnancy or jaundice with prior pill use.
Hepatic adenomas or carcinomas, or active liver disease, as long as liver function has not returned to normal.
Known or suspected pregnancy.
Hypersensitivity to any of the components of Nordette®-28 (levonorgestrel and ethinyl estradiol tablets).

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 8/23/2013


Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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