"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"...
- Patient Information:
Details with Side Effects
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.
Non-Contraceptive Health Benefits
The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.6-11
Effects on menses:
- Increased menstrual cycle regularity
- Decreased blood loss and decreased incidence of iron deficiency anemia
- Decreased incidence of dysmenorrheal
Effects related to inhibition of ovulation:
Effects from long-term use:
Oral contraceptives should not be used in women who have the following conditions:
- Thrombophlebitis or thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebral vascular or coronary artery disease
- 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, carcinomas or benign liver tumors
- Known or suspected pregnancy
6. The Cancer and Steroid Hormone Study of the Centers for Disease Control: JAMA 249 (2): 1596- 1599, 1983. 7. The Cancer and Steroid Hormone Study of the Centers for Disease Control: JAMA 257 (6): 796-800, 1987. 8. Ory, H.W.: JAMA 228 (1): 68-69, 1974. 9. Ory, H.W., et al.: N Engl J Med 294: 419-422, 1976. 10. Ory, H.W.: Fam Plann Perspect 14: 182-184, 1982. 11. Ory, H.W., et al.: Making Choices, New York, The Alan Guttmacher Institute, 1983.
Address medical inquiries to: Watson Pharma, Inc. Medical Communications P.O. Box 1953 Morristown, NJ 07962-1953. 800-272-5525. Manufactured for: WATSON PHARMA, INC. A subsidiary of Watson Pharmaceuticals, Inc. Corona, CA 92880, USA. by: Patheon Inc. Mississauga, Ontario L5N 7K9 CANADA. Revised: May 2005. FDA Rev date: 8/16/2001
Last reviewed on RxList: 3/26/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Levora Information
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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