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Zovia (Ethynodiol Diacetate / Ethinyl Estradiol) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

7. Drug interactions.

Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. A similar association, though less marked, has been suggested for barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines. Administration of troglitazone concomitantly with a combination oral contraceptive (estrogen and progestin) reduced the plasma concentrations of both hormones by approximately 30%. This could result in loss of contraceptive efficacy.

OVERDOSAGE

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children.180, 181 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 that largely utilized oral contraceptive formulations containing estrogen doses exceeding 35 mcg of ethinyl estradiol or 50 mcg of mestranol.148, 149

Effects on menses:

  • Increased menstrual cycle regularity

  • Decreased blood loss and decreased risk of iron-deficiency anemia

  • Decreased frequency of dysmenorrhea

Effects related to inhibition of ovulation:

  • Decreased risk of functional ovarian cysts

  • Decreased risk of ectopic pregnancies

Effects from long-term use:

  • Decreased risk of fibroadenomas and fibrocystic disease of the breast

  • Decreased risk of acute pelvic inflammatory disease

  • Decreased risk of endometrial cancer

  • Decreased risk of ovarian cancer

  • Decreased risk of uterine fibroids

CONTRAINDICATIONS

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 disease, myocardial infarction, or coronary artery disease, or a past history of these conditions

  • Known or suspected carcinoma of the breast, or a history of this condition

  • Known or suspected carcinoma of the female reproductive organs or suspected estrogendependent neoplasia, or a history of these conditions

  • Undiagnosed abnormal genital bleeding

  • History of cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use

  • Past or present, benign or malignant liver tumors

  • Known or suspected pregnancy

REFERENCES

1. Hatcher RA, et al. Contraceptive Technology: Seventeenth Revised Edition. New York, NY, 1998. 1a. Physicians’ Desk Reference. 47th ed. Oradell, NJ: Medical Economics Co Inc; 1993;2598-2601. 2. Mann JI, et al. Br Med J. 1975; 2 (May 3):241. 3. Mann JI, et al. Br Med J. 1975;3(Sept 13):631. 4. Mann JI, et al. Br Med J. 1975;2(May 3):245. 5. Mann JI, et al. Br Med J. 1976;2(Aug 21):445. 6. Arthes FG, et al. Chest. 1976;70 (Nov):574. 7. Jain AK, Am J Obstet Gynecol. 1976;301(Oct 1):126 and Stud Fam Plann. 1977;8(March):50. 8. Ory HW. JAMA. 1977;237(June 13):2619. 9. Jick H, et al. JAMA. 1978;239(April 3):1403, 1407. 10. Jick H, et al. JAMA. 1978;240(Dec 1):2548. 11. Shapiro S, et al. Lancet. 1979;1(April 7):743. 12. Rosenberg L, et al. Am J Epidemiol. 1980;111(Jan):59. 13. Krueger DE, et al. Am J Epidemiol. 1980;111 (June):655. 14. Layde P, et al. Lancet. 1981;1(March 7):541. 15. Adam SA, et al. Br J Obstet Gynaecol. 1981;88(Aug):838. 16. Slone D, et al. N Engl J Med. 1981;305 (Aug 20):420. 17. Ramcharan S, et al. The Walnut Creek Contraceptive Drug Study. Vol 3. US Govt Ptg Off. 1981; and J Reprod Med. 1980;25(Dec):346. 18. Layde PM, et al. J R Coll Gen Pract. 1983;33(Feb):75. 19. Rosenberg L, et al. JAMA. 1985;253(May 24/31):2965. 20. Mant D, et al. J Epidemiol Community Health. 1987;41 (Sept):215. 21. Croft P, et al. Br Med J. 1989;298 (Jan 21):165. 22. Goldbaum GM, et al. JAMA. 1987;258(Sept 11):1339. 23. Bradley DD, et al. N Engl J Med. 1978;299(July 6):17. 24. Tikkanen MJ. J Reprod Med. 1986;31(Sept suppl):898. 25. Lipson A, et al. Contraception. 1986;34(Aug):121. 26. Burkman RT, et al. Obstet Gynecol. 1988; 71(Jan):33. 27. Knopp RH, J Reprod Med. 1986;31(Sept Suppl):913. 28. Krauss RM, et al. Am J Obstet Gynecol. 1983;145(Feb 15):446. 29. Wahl P, et al. N Engl J Med. 1983;308(April 14):862. 30. Wynn V, et al. Am J Obstet Gynecol. 1982;142(March 15):766. 31. LaRosa JC. J Reprod Med. 1986;31(Sept suppl):906. 32. Wynn V, et al. J Reprod Med. 1986;31(Sept Suppl):892. 33. Royal College of General Practitioners. J R Coll Gen Pract. 1967;13(May):267. 34. Inman WHW, et al. Br Med J. 1968;2(April 27):193. 35. Vessey MP, et al. Br Med J. 1968;2(April 27):199. 36. Vessey MP, et al. Br Med J. 1969;2(June 14):651. 37. Sartwell PE, et al. Am J Epidemiol. 1969;90(Nov):365. 38. Vessey MP, et al. Br Med J. 1970;3(July 18):123. 39. Greene GR, et al. Am J Public Health. 1972;62(May):680. 40. Boston Collaborative Drug Surveillance Programme. Lancet. 1973;1(June 23):1399. 41. Stolley PD, et al. Am J Epidemiol. 1975;102(Sept):197. 42. Vessey MP, et al. J Biosoc Sci. 1976;8(Oct):373. 43. Kay CR, J R Coll Gen Pract. 1978;28(July):393. 44. Petitti DB, et al. Am J Epidemiol. 1978;108 (Dec):480. 45. Maquire MG, et al. Am J Epidemiol. 1979;110(Aug):188. 46. Petitti DB, et al. JAMA. 1979;242(Sept 14):1150. 47. Porter JB, et al. Obstet Gynecol. 1982;59(March):299. 48. Porter JB, et al. Obstet Gynecol. 1985;66(July):1. 49. Vessey MP, et al. Br Med J. 1986;292(Feb 22):526. 50. Hoover R, et al. Am J Public Health. 1978;68(April):335. 51. Vessey MP, Br J Fam Plann. 1980;6(Oct suppl):1. 52. Collaborative Group for the Study of Stroke in Young Women. N Engl J Med. 1973;288(April 26):871. 53. Royal College of General Practitioners. Oral Contraceptives and Health. New York, NY: Pitman Publ Corp; May 1974. 54. Collaborative Group for the Study of Stroke in Young Women. JAMA. 1975;231(Feb 17):718. 55. Beral V. Lancet. 1976;2(Nov 13):1047. 56. Vessey MP, et al. Lancet. 1977;2(Oct 8):731; and 1981;1(March 7):549. 57. Petitti DB, et al. Lancet. 1978;2(July 29):234. 58. Inman WHW. Br Med J. 1979;2(Dec 8):1468. 59. Vessey MP, et al. Br Med J. 1984; 289(Sept 1):530. 60. Inman WHW, et al. Br Med J. 1970;2(April 25):203. 61. Meade TW, et al. Br Med J. 1980;280(May 10):1157. 62. Böttiger LE, et al. Lancet. 1980;1(May 24):1097. 63. Kay CR. Am J Obstet Gynecol. 1982;142(March 15):762. 64. Vessey MP, et al. Br Med J. 1986;292(Feb 22):526. 65. Gordon T, et al. Am J Med. 1977;62(May):707. 66. Beral V, et al. Lancet. 1977;2(Oct 8):727. 67. Ory H. Fam Plann Perspect. 1983;15(March-April):57. 68. Arthes FG, et al. Cancer. 1971;28 (Dec):1391. 69. Vessey MP, et al. Br Med J. 1972;3(Sept 23):719. 70. Boston Collaborative Drug Surveillance Program. N Engl J Med. 1974;290(Jan 3):15. 71. Vessey MP, et al. Lancet. 1975;1(April 26):941. 72. Casagrande J, et al. J Natl Cancer Inst. 1976;56(April):839. 73. Kelsey, JL, et al. Am J Epidemiol. 1978;107(March):236. 74. Kay CR, Br Med J. 1981;282(June 27):2089. 75. Vessey MP, et al. Br Med J. 1981;282(June 27):2093. 76. The Cancer and Steroid Hormone Study of the Centers for Disease Control and the National Institute of Child Health and Human Development. Oral contraceptive use and the risk of breast cancer. N Engl J Med. 1986;315(Aug 14):405. 77. Paul C, et al. Br Med J. 1986; 293 (Sept 20):723. 78. Miller DR, et al. Obstet Gynecol. 1986;68(Dec):863. 79. Pike MC, et al. Lancet. 1983;2(Oct 22):926. 80. McPherson K, et al. Br J Cancer. 1987;56(Nov):653. 81. Hoover R, et al. N Engl J Med. 1976;295(Aug 19):401. 82. Lees AW, et al. Int J Cancer. 1978;22(Dec):700. 83. Brinton LA, et al. J Natl Cancer Inst. 1979;62(Jan):37. 84. Black MM. Pathol Res Pract. 1980;166:491; and Cancer. 1980;46(Dec):2747; and Cancer. 1983;51(June):2147. 85. Thomas DB. JNCI. 1993;85 (March 3):359. 86. Brinton LA, et al. Int J Epidemiol. 1982;11(Dec):316. 87. Harris NV, et al. Am J Epidemiol. 1982;116(Oct):643. 88. Jick H, et al. Am J Epidemiol. 1980;112(Nov):577. 89. McPherson K, et al. Lancet. 1983;2(Dec 17):1414. 90. Hoover R, et al. J Natl Cancer Inst. 1981; 67(Oct):815. 91. Jick H, et al. Am J Epidemiol. 1980; 112(Nov):586. 92. Meirik O, et al. Lancet. 1986;2 (Sept 20):650. 93. Fasal E, et al. J Natl Cancer Inst. 1975;55(Oct):767. 94. Paffenbarger RS, et al. Cancer. 1977;39(April suppl):1887. 95. Stadel BV, et al. Contraception. 1988;38(Sept):287. 96. Miller DR, et al. Am J Epidemiol. 1989;129(Feb):269. 97. Kay CR, et al. Br J Cancer. 1988;58(Nov):675. 98. Miller DR, et al. Obstet Gynecol. 1986;68(Dec):863. 99. Hulka BS, et al. Cancer. 1994;74(August 1 suppl):1111. 100. Chilver CED, et al. Br J Cancer. 1994;67(May):922. 101. Huggins GR, et al. Fertil Steril. 1987;47(May):733. 102. Pike MC, et al. Br J Cancer. 1981;43(Jan):72. 103. Ory H, et al. Am J Obstet Gynecol. 1976;124(March 15):573. 104. Stern E, et al. Science. 1977;196(June 24):1460. 105. Pertiz E, et al. Am J Epidemiol. 1977;106(Dec):462. 106. Ory HW, et al. In: Garattini S, Berendes H, eds. Pharmacology of Steroid Contraceptive Drugs. New York, NY: Raven Press; 1977:211-224. 107. Meisels A, et al. Cancer. 1977;40(Dec):3076. 108. Goldacre MJ, et al. Br Med J. 1978;1(March 25):748. 109. Swan SH, et al. Am J Obstet Gynecol. 1981;139(Jan 1):52. 110. Vessey MP, et al. Lancet. 1983;2(Oct 22):930. 111. Dallenbach-Hellweg G. Pathol Res Pract. 1984;179:38. 112. Thomas DB, et al. Br Med J. 1985;290(March 30):961. 113. Brinton LA, et al. Int J Cancer. 1986;38(Sept):339. 114. Ebeling K, et al. Int J Cancer. 1987;39(April):427. 115. Beral V, et al. Lancet. 1988;2(Dec 10):1331. 116. Baum JK, et al. Lancet. 1973;2(Oct 27):926. 117. Edmondson HA, et al. N Engl J Med. 1976;294(Feb 26):470. 118. Bein NN, et al. Br J Surg. 1977;64(June):433. 119. Klatskin G. Gastroenterology. 1977;73(Aug):386. 120. Rooks JB, et al. JAMA. 1979;242(Aug 17):644. 121. Sturtevant FM. In: Moghissi K, ed. Controversies in Contraception, Baltimore, MD; Williams & Wilkins; 1979:93-150. 122. Henderson BE, et al. Br J Cancer. 1983;48(July):437. 123. Neuberger J, et al. Br Med J. 1986;292(May 24):1355. 124. Forman D, et al. Br Med J. 1986;292(May 24):1357. 125. La Vecchia C, et al. Br J Cancer. 1989;59(March):460. 126. Savolainen E, et al. Am J Obstet Gynecol 1981;140(July 1):521. 127. Ferencz C, et al. Teratology. 1980;21(April):225. 128. Rothman KJ, et al. Am J Epidemiol. 1979;109(April):433. 129. Harlap S, et al. Obstet Gynecol. 1980;55(April):447. 130. Layde PM, et al. J Epidemiol Community Health. 1982;36(Dec):274. 131. Rome Group for the Epidemiology and Prevention of Cholelithiasis (GREPCO). Am J Epidemiol. 1984;119(May):796. 132. Strom BL, et al. Clin Pharmacol Ther. 1986;39(March):335. 133. Wynn V. In: Bardin CE, et al, eds. Progesterone and Progestins. New York, NY: Raven Press; 1983:395-410. 134. Perlman JA, et al. J Chron Dis. 1985;38(Oct):857. 135. Powell MG, et al. Obstet Gynecol. 1984;63(June):764. 136. Wynn V, et al. Lancet. 1966;2(Oct 1):720. 137. Fisch IR, et al. JAMA. 1977;237(June 6):2499. 138. Kay CR. Lancet. 1977;1(March 19):624. 139. Laragh JH. Am J Obstet Gynecol. 1976;126(Sept 1):141. 140. Ramcharan S. In: Garattini S, Berendes HW, eds. Pharmacology of Steroid Contraceptive Drugs. New York, NY: Raven Press; 1977:277-288. 141. Laumas KR, et al. Am J Obstet Gynecol. 1967;98(June 1):411. 142. Saxena BN, et al. Contraception. 1977;16(Dec):605. 143. Nilsson S, et al. Contraception. 1978;17(Feb):131. 144. Washington AE, et al. JAMA. 1985;253(April 19):2246. 145. Louv WC, et al. Am J Obstet Gynecol. 1989;160(Feb):396. 146. Francis WG, et al. Can Med Assoc J. 1965;92(Jan 23):191. 147. Verhulst HL, et al. J Clin Pharmacol. 1967:7(Jan-Feb):9. 148. Ory HW, Fam Plann Perspect. 1982;14(July-Aug):182. 149. Ory HW, et al. Making Choices: Evaluating the Health Risks and Benefits of Birth Control Methods. New York, NY: The Alan Guttmacher Institute; 1983. 150. Palmer JR, et al. Am J Epidemiol. 1989;130(Nov):878. 151. Romieu I, et al. J Natl Cancer Inst. 1989;81(Sept):1313. 152. Porter JB, et al. Obstet Gynecol. 1987;70(July):29. 153. Olsson H, et al. Cancer Detect Prev. 1991;15:265. 154. Delgado-Rodriguez M, et al. Rev Epidém Santé Publ. 1991;39:165. 155. Clavel F, et al. Int J Epidemiol. 1991;20(March):32. 156. Brinton LA, et al. JNCI. 1995;87(June 7):827. 157. Thomas DB, et al. Br J Cancer. 1992;65(January):108. 158. Thomas DB, et al. Cancer Causes Cont. 1991;2(Nov):389. 159. Weinstein AL, et al. Epidemiology. 1991;2(Sept):353. 160. Ranstam J, et al. Anticancer Res. 1991;11(Nov-Dec):2043. 161. Ursin G. et al. Epidemiology. 1992;3(Sept):414. 162. White E, et al. JNCI. 1994;86(April 6):505. 163. Mann R, et al. Oral contraceptives and Breast Cancer. Park Ridge, NJ: The Parthenon Publishing Group Inc.; 1990. 164. Institute of Medicine. Committee on the Relationship Between Oral Contraceptives and Breast Cancer. Oral Contraceptives and Breast Cancer. Washington, DC: National Academy Press; 1991. 165. Harlap S. J Reprod Med. 1991;36(May):374. 166. Rushton L, et al. Br J Obstet Gynaecol. 1992;99(March):239. 167. Colditz G. Cancer. 1993;71(Feb 15 suppl):1480.

BRIEF SUMMARY OF PATIENT WARNINGS

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

In the detailed leaflet, “What You Should Know About Oral Contraceptives,” which you have received, the risks and benefits of oral contraceptives are discussed in much more detail. That leaflet also provides information on other forms of contraception. Please take time to read it carefully for it may have been recently revised.

If you have any questions or problems regarding this information, contact your doctor.

Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. However, forgetting to take pills considerably increases the chances of pregnancy.

For most women, oral contraceptives are free of serious or unpleasant side effects. However, oral contraceptive use is associated with certain serious diseases or conditions that can cause severe disability or death, though rarely. There are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:

  • smoke, or

  • have high blood pressure, diabetes, high cholesterol, or are overweight, or

  • have or have had clotting disorders, heart attack, stroke, angina pectoris (chest pains on exertion), cancer of the breast or sex organs, jaundice (yellowing of the skin or whites of the eyes), or malignant (cancerous) or benign (noncancerous) liver tumors.

Women should not use oral contraceptives if they suspect they are pregnant or if they have unexplained vaginal bleeding.

Most side effects of the pill are not serious. The most common effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.

Proper use of oral contraceptives requires that they be taken under your doctor’s continuing supervision, because they can be associated with serious side effects. The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill, and that certain of the risks may persist after use of the pill has been discontinued:

  • Blood clots in the legs, arms, lungs, heart (heart attack), eyes, abdomen, or elsewhere in the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences.

  • Stroke, due to a blood clot, or to bleeding in the brain (hemorrhage) as a result of bursting of a blood vessel. Stroke can lead to paralysis in all or part of the body, or to death.

  • Liver tumors, which may rupture and cause severe bleeding and death. A possible, but not definite, association has also been found with the pill and liver cancer. However, with or without use of the pill, liver cancers are extremely rare in the United States.

  • High blood pressure, although blood pressure ordinarily, but not always, returns to original levels when the pill is stopped.

  • Gallbladder disease, which might require surgery.

The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health care provider if you notice any unusual physical disturbances while taking the pill. In addition, you should be aware that drugs such as antiepileptics, antibiotics (especially rifampin), as well as certain other drugs, may decrease oral contraceptive effectiveness.

There is a conflict among studies regarding breast cancer and oral contraceptive use. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. The majority of studies have found no overall increase in the risk of developing breast cancer. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility that pills may cause such cancers.

Taking the pill may provide some important non-contraceptive benefits. These include less painful menstruation, less menstrual blood loss and anemia, less risk of fibroids, pelvic infections, and noncancerous breast disease, and less risk of cancer of the ovary and of the lining of the uterus (womb).

Be sure to discuss any medical condition you may have with your health care provider. He or she will take a medical and family history before prescribing oral contraceptives and will also examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information that you should read and discuss with your health care provider.

DETAILED PATIENT LABELING

WHAT YOU SHOULD KNOW ABOUT ORAL CONTRACEPTIVES

This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

INTRODUCTION

You should not use Zovia 1/50E, which contains higher doses of estrogen than other oral contraceptives, unless specifically recommended by your health care provider.

It is important that any woman who considers using an oral contraceptive understand the risks involved. Although the oral contraceptives have important advantages over other methods of contraception, they have certain risks that no other method has. Only you and your physician can decide whether the advantages are worth these risks. This leaflet will tell you about the most important risks. It will explain how you can help your doctor prescribe the pill as safely as possible by telling him/her about yourself and being alert for the earliest signs of trouble. And it will tell you how to use the pill properly so that it will be as effective as possible. THERE IS MORE DETAILED INFORMATION AVAILABLE IN THE LEAFLET PREPARED FOR DOCTORS. Your pharmacist can show you a copy; you may need your doctor’s help in understanding parts of it.

This leaflet is not a replacement for a careful discussion between you and your health care provider. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your health care provider’s advice with regard to regular check-ups while you are on the pill.

If you do not have any of the conditions listed below and are thinking about using oral contraceptives, to help you decide, you need information about the advantages and risks of oral contraceptives and of other contraceptive methods as well. This leaflet describes the advantages and risks of oral contraceptives. Except for sterilization, the intrauterine device (IUD), and abortion, which have their own specific risks, the only risks of other methods are those due to pregnancy should the method fail. Your doctor can answer questions you may have with respect to other methods of contraception, and further questions you may have on oral contraceptives after reading this leaflet.

WHAT ARE ORAL CONTRACEPTIVES?

The most common type of oral contraceptive, often simply called “the pill,” is a combination of estrogen and progestogen, the two kinds of female hormones. The amount of estrogen and progestogen can vary, but the amount of estrogen is more important because both the effectiveness and some of the dangers of the pill have been related to the amount of estrogen. The pill works principally by preventing release of an egg from the ovary during the cycle in which the pills are taken.

EFFECTIVENESS OF ORAL CONTRACEPTIVES

The pill is one of the most effective methods of birth control. When they are taken correctly, without missing any pills, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when used perfectly, without missing any pills. Typical failure rates are actually about 3% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

In comparison, typical failure rates for other methods of birth control during the first year of use are as follows:

Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States.
% of women experiencing % of women
an unintended pregnancy continuing
within the first year of use use at one
year (C)
Method Typical use (A) Perfect use (B)
(1) (2) (3) (4)
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press. 1
(A) Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(B) Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
(C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
(D) The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
(E) Foams, creams, gels, vaginal suppositories, and vaginal film.
(F) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
(G) With spermicidal cream or jelly.
(H) Without spermicides.
(I) The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
(J) However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.
Chance (D) 8585
Spermicides (E) 26640
Periodic abstinence2563
Calendar9
Ovulation method3
Sympto-thermal (F) 2
Post-ovulation1
Withdrawal194
Cap (G)
Parous women402642
Nulliparous women20956
Sponge
Parous women402042
Nulliparous women20956
Diaphragm (G) 20656
Condom (H)
Female (Reality)21556
Male14361
Pill571
Progestin only0.5
Combined0.1
IUD
Progesterone T2.01.581
Copper T 380A0.80.678
LNg 200.10.181
Injection (Depo-Provera)0.30.370
Implant (Norplant0.050.0588
and Norplant-2)
Female sterilization0.50.5100
Male sterilization0.150.10100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. (I)
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. (J)

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have any of the following conditions:

  • Heart attack or stroke (blood clot or hemorrhage in the brain), currently or in the past.

  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), eyes, or elsewhere in the body, currently or in the past.

  • Chest pain (angina pectoris), currently or in the past.

  • Known or suspected breast cancer or cancer of the lining of the uterus (womb), cervix, or vagina, currently or in the past.

  • Unexplained vaginal bleeding (until a diagnosis is reached by your doctor).

  • Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill.

  • Liver tumor (whether cancerous or not), currently or in the past.

  • Known or suspected pregnancy (one or more menstrual periods missed).

Tell your health care provider if you have ever had any of these conditions. He or she can recommend a safer method of birth control.

OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES

Tell your health care provider if you have or have had any of the following conditions, as he or she will want to watch them closely or they might cause him or her to suggest using another method of contraception:

  • Breast nodules (lumps), fibrocystic disease (breast cysts), abnormal mammograms (x-ray pictures of the breast), or abnormal Pap smears

  • Diabetes

  • High blood pressure

  • High blood cholesterol or triglycerides

  • Migraine or other headaches or epilepsy

  • Mental depression

  • Gallbladder, heart, or kidney disease

  • History of scanty or irregular menstrual periods

  • Problems during a prior pregnancy

  • Fibroid tumors of the womb

  • History of jaundice (yellowing of the whites of the eyes or of the skin)

  • Varicose veins

  • Tuberculosis

  • Plans for elective surgery

Women with any of these conditions should be checked often by their health care provider if they choose to use oral contraceptives.

Also, be sure to tell your doctor if you smoke or are on any medications.

RISKS OF TAKING ORAL CONTRACEPTIVES

1. Risk of developing blood clots. Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.

If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness, or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping oral contraceptives 3 to 4 weeks before surgery and not taking oral contraceptives for 2 weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least 4 weeks after delivery if you are not breast feeding. If you are breast feeding, you should wait until you have weaned your child before using the pill. (See also the section on Breast feeding in GENERAL PRECAUTIONS.)

The risk of circulatory disease in oral contraceptive users may be higher in users of high-dose pills and may be greater with longer duration of oral contraceptive use. In addition, some of these increased risks may continue for a number of years after stopping oral contraceptives. The risk of abnormal blood clotting increases with age in both users and nonusers of oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages. For women aged 20 to 44 it is estimated that about 1 in 2,000 using oral contraceptives will be hospitalized each year because of abnormal clotting. Among nonusers in the same age group, about 1 in 20,000 would be hospitalized each year. For oral contraceptive users in general, it has been estimated that in women between the ages of 15 and 34, the risk of death due to a circulatory disorder is about 1 in 12,000 per years, whereas for nonusers the rate is about 1 in 50,000 per year. In the age group 35 to 44, the risk is estimated to be about 1 in 2,500 per year for oral contraceptive users and about 1 in 10,000 per year for nonusers.

2. Heart attacks and strokes. Oral contraceptives may increase the tendency to develop strokes (stoppage by blood clots or rupture of blood vessels of the brain) and angina pectoris and heart attacks (blockage of blood vessels of the heart). Any of these conditions can cause death or permanent disability.

Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increases the chances of developing and dying of heart disease.

3. Gallbladder disease. Oral contraceptive users probably have a greater risk than non-users of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens.

4. Liver tumors. In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in several studies, in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are rare.

5. Cancer of the reproductive organs and breasts. There is conflict among studies regarding breast cancer and oral contraceptive use. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use. The majority of studies have found no overall increase in the risk of developing breast cancer. Women who use oral contraceptives and have a strong family history of breast cancer or who have had breast nodules or abnormal mammograms should be closely followed by their doctors.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility that pills may cause such cancers.

ESTIMATED RISK OF DEATH
FROM BIRTH CONTROL METHOD OR PREGNANCY

All methods of birth control and pregnancy are associated with a risk of developing certain diseases that may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table.

Annual number of birth-related or method-related deaths associated with control of fertility per 100,000 nonsterile women, by fertility control method according to age.
Age
Method of control 15-19 20-24 25-29 30-34 35-39 40-44
* Deaths are birth-related
** Deaths are method-related
No fertility control methods*7.07.49.114.825.728.2
Oral contraceptives
nonsmoker**0.30.50.91.913.831.6
smoker**2.23.46.613.551.1117.2
IUD**0.80.81.01.01.41.4
Condom*1.11.60.70.20.30.4
Diaphragm/Spermicide*1.91.21.21.32.22.8
Periodic abstinence*2.51.61.61.72.93.6

In the above table, the risk of death from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7-26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000) in that age group.

The suggestion that women over 40 who don’t smoke should not take oral contraceptives is based on information from older high-dose pills and on less selective use of pills than is practiced today. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, nonsmoking women over 40 years of age may outweigh the possible risks. However, all women, especially older women, are cautioned to use the lowest dose pill that is effective.

WARNING SIGNALS

If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately:

  • Sharp chest pain, coughing up blood, or sudden shortness of breath (indicating a possible blood clot in the lung).

  • Pain in the calf (indicating a possible blood clot in the leg).

  • Crushing chest pain or heaviness in the chest (indicating a possible heart attack).

  • Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, or numbness in an arm or leg (indicating a possible stroke).

  • Sudden partial or complete loss of vision (indicating a possible blood clot in the blood vessels of the eye).

  • Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast). Ask your doctor or health care provider to show you how to examine your own breasts.

  • Severe pain or tenderness or a mass in the stomach area (indicating a possible ruptured liver tumor).

  • Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression).

  • Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements (indicating possible liver problems).

  • Unusual swelling.

  • Other unusual conditions.

SIDE EFFECTS OF ORAL CONTRACEPTIVES

1. Vaginal bleeding.

Spotting. This is a slight staining between your menstrual periods that may not even require a pad. Some women spot even though they take their pills exactly as directed. Many women spot although they have never taken the pills. Spotting does not mean that your ovaries are releasing an egg. Spotting may be the result of irregular pill-taking. Getting back on schedule will usually stop it.

If you should spot while taking the pills, you should not be alarmed, because spotting usually stops by itself within a few days. It seldom occurs after the first pill cycle. Consult your doctor if spotting persists for more than a few days or if it occurs after the second cycle.

Unexpected (breakthrough) bleeding. Unexpected (breakthrough) bleeding does not mean that your ovaries have released an egg. It seldom occurs, but when it does happen it is most common in the first pill cycle. It is a flow much like a regular period, requiring the use of a pad or tampon.

If you experience breakthrough bleeding use a pad or tampon and continue with your schedule. Usually your periods will become regular within a few cycles. Breakthrough bleeding will seldom bother you again.

Consult your doctor or health care provider if breakthrough bleeding is heavy, does not stop within a week, or if it occurs after the second cycle.

2. Contact lenses. If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health care provider.

3. Fluid retention or raised blood pressure. Oral contraceptives may cause edema (fluid retention), with swelling of the fingers or ankles. If you experience fluid retention, contact your doctor or health care provider. Some women develop high blood pressure while on the pill, which ordinarily, but not always, returns to the original levels when the pill is stopped. High blood pressure predisposes one to strokes, heart attacks, kidney disease, and other diseases of the blood vessels.

4. Melasma. A spotty darkening of the skin is possible, particularly of the face. This may persist after the pill is discontinued.

5. Other side effects. Other side effects may include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections.

If any of these, or other, side effects occur, call your doctor or health care provider.

GENERAL PRECAUTIONS

1. Missed periods and use of oral contraceptives before or during early pregnancy.

Occasionally women who are taking the pill miss periods. It has been reported to occur as frequently as several times each year in some women, depending on various factors such as age and prior history (your doctor is the best source of information about this). The pill should not be used when you are pregnant or suspect you may be pregnant. Very rarely, women who are using the pill as directed become pregnant. The likelihood of becoming pregnant is higher if you occasionally miss one or two pills. Therefore, if you miss a period you should consult your physician before continuing to take the pill. If you miss a period, especially if you have not taken the pill regularly, you should use an alternative method of contraception until pregnancy has been ruled out; if you have missed more than one pill at any time, you should immediately start using an additional method of contraception and complete your pill cycle.

There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these findings have not been seen in more recent studies. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor. You should check with your doctor about risks to your unborn child of any medication taken during pregnancy.

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