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References

  1. LYBREL® (90 mcg levonorgestrel and 20 mcg ethinyl estradiol) Tablets Prescribing Information, Wyeth Pharmaceuticals Inc.
  2. United States Food and Drug Administration. LYBREL™ approval letter, May 22, 2007.
  3. LYBREL patent, US 6,500,814 B1; December 31, 2002.
  4. Seasonale® (levonorgestrel/ethinyl estradiol tablets) 0.15 mg/0.03 mg Prescribing Information, Barr Laboratories, Inc., Pomona, NY.
  5. ALESSE® 28 Tablets (levonorgestrel and ethinyl estradiol tablets) Prescribing Information, Wyeth Pharmaceuticals Inc.
  6. YAZ® (drospirenone and ethinyl estradiol) Tablets Package Insert, Berlex, Montville, NJ.
  7. United States Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations. 26th ed. 2006.
  8. Loose-Mitchell DS, Stancel GM. Estrogens and progestins. In: Hardman JG, Limbird LE, Gilman AG, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001:1597-1629.
  9. Data on file, Wyeth Pharmaceuticals Inc.
  10. Archer DF, Jensen JT, Johnson JV, et al. Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results. Contraception. 2006;74:439-445.
  11. Belsey EM, Machin D, d’Arcangues C. The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1986;34:253-260.
  12. United States Food and Drug Administration. Labeling guidance for combination oral contraceptives. Revised August 1994.
  13. Lohr PA, Creinin MD. Oral contraceptives and breakthrough bleeding: What patients need to know. The Journal Of Family Practice. October 2006:872-880.
  14. Darney PD. OC practice guidelines: minimizing side effects. Int J Fertil. 1997;42(suppl 1):158-169.
  15. Krettek JE, Arkin SI, Chaisilwattana P, et al. Chlamydia trachomatis in patients who used oral contraceptives and had intermenstrual spotting. Obstet Gynecol. 1993;81:728-731.

Important Safety Information

  • Oral contraceptives (OCs) do not protect against HIV infection or other sexually transmitted diseases.
  • When prescribing LYBREL, the convenience of having no scheduled menstrual bleeding should be weighed against the inconvenience of unscheduled breakthrough bleeding and spotting.
  • OCs are contraindicated in women who have blood clots; breast, uterine, or liver cancers; a history of heart attack, stroke, or breast cancer; as well as those who are or may be pregnant.
The risks of serious cardiovascular side effects are substantially increased in women who smoke and use OCs, especially in women over age 35. Women who use oral contraceptives should be strongly advised not to smoke.
  • Serious risks associated with OCs include blood clots, heart attack, and stroke.
  • LYBREL provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year) than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins.
  • Scheduled withdrawal bleeding does not occur with the use of LYBREL, therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy and as such, unexpected pregnancy may be difficult to recognize. Although pregnancy is unlikely if LYBREL is taken as directed, if for any reason, pregnancy is suspected in a woman using LYBREL, a pregnancy test should be performed.
  • The most commonly reported treatment emergent adverse events reported with LYBREL in a clinical trial were headache, dysmenorrhea, upper respiratory infection, vaginal bleeding (defined as metrorrhagia and vaginal hemorrhage), and nausea.

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