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Yasmin (drospirenone-ethinyl estradiol) - Stroke

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Yasmin may cause the following symptoms that are related to stroke (can cause signs of brain dysfunction including one-sided weakness, numbness, loss of sensation; headache and vomiting; changes in vision, hearing, taste; speech problems or slurred speech; balance problems; dizziness; weakness in facial muscle and tongue; facial or eyelid drooping; loss of consciousness; coma):

Medical Source Information
Yellow highlights indicate symptoms related to stroke.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects: sudden numbness or weakness, confusion, pain behind the eyes, problems with vision, speech, or balance; chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; a change in the pattern or severity of migraine headaches; stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes); a breast lump; or symptoms of depression (sleep problems, weakness, mood changes). Less serious side effects may include: breast pain, tenderness, or swelling; freckles or darkening of facial skin, increased hair growth, or loss of scalp hair; changes in weight or appetite, swelling of your hands or feet; problems with contact lenses; vaginal itching or discharge; or changes in your menstrual periods. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Cardiovascular side effects of the estrogen component of this combination drug may be significant and have included hypertension. However, significant blood pressure increases generally occur only in women receiving high-dose estrogen products (50 mcg or more of ethinyl estradiol or equivalent daily). Estrogens have also been associated with edema. Other cardiovascular side effects have included aggravation of varicose veins.

Some early investigations of women taking high dose estrogen combinations (50 mcg or more of ethinyl estradiol or equivalent daily) suggested that such women may be at increased risk of cardiovascular complications (myocardial infarction, stroke, and vascular thrombosis, including venous thromboembolism). However, more recent large investigations of women taking low dose estrogen combinations have suggested that oral contraceptive use is not associated with an increased risk of serious cardiovascular complications in healthy non smoking women up to the age of 45. (For women aged 35 to 44 who smoke or who have preexisting systemic diseases that may affect the cardiovascular system, use of oral contraceptives is not recommended.) However, some investigators have suggested that even the new low dose products may result in adverse effects on lipid metabolism and should prompt careful review of a woman's cardiovascular risk factors before a decision to use oral contraceptive combinations is made. The frequency of both subarachnoid hemorrhage and thrombotic stroke has been reported by some investigators to be higher in women taking oral contraceptive hormones. However, other investigators have suggested that the risk of these effects for women using newer low dose formulations are very small for young women without underlying cardiovascular disease or other risk factors.

Use of drospirenone-ethinyl estradiol is contraindicated for women who have the following conditions: renal insufficiency, hepatic dysfunction, adrenal insufficiency, thrombophlebitis or thromboembolic disorders, a past history of deep-vein thrombophlebitis or thromboembolic disorders, cerebrovascular 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 oral contraceptive use, liver tumor (benign or malignant) or active liver disease, and known or suspected pregnancy.

The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:
  • Abnormal bruising or signs of bleeding such as bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash (signs of problems with blood clot formation)
Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):
  • Monitor estradiol, glucose and potassium
  • Blood tests to assess normal clotting - in people who develop signs of bleeding such as abnormal bruising or signs of bleeding including bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash
References
  1. Oral contraceptives are a risk factor for cerebral vein thrombosis. Martinelli I, Rosendaal FR, Vandenbroucke JP, Mannucci PM Thromb Haemost 1996;76:477-8.
  2. Oral contraceptives, sex steroid-induced antibodies and vascular thrombosis: results from 1318 cases. Beaumont V, Lemort N, Beaumont JL Eur Heart J 1991;12:1219-24.
  3. Ischaemic stroke and combined oral contraceptives: results of an international, multicentre, case-control study. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG, Debertribeiro M, Medina E, Artigas J, Shen H, Zhong YH, Zhang DW, Lancet 1996;348:498-505.
  4. Pulmonary embolus in an adolescent on oral contraceptives. Key JD, Hammill WW, Everett L J Adolesc Health 1992;13:713-5.
  5. Oral contraceptives and thrombotic diseases: impact of new epidemiological studies. Farley TMM, Meirik O, Poulter NR, Chang CL, Marmot MG Contraception 1996;54:193-5.
  6. Haemorrhagic stroke, overall stroke risk, and combined oral contraceptives: results of an international, multicentre, case-control study. Poulter NR, Chang CL, Farley TMM, Meirik O, Marmot MG Lancet 1996;348:505-10.
  7. Oral contraceptive use and coronary risk factors in women. Leaf DA, Bland D, Schaad D, Neighbor WE, Scott CS Am J Med Sci 1991;301:365-8.
  8. Fatal stroke and use of oral contraceptives: findings from a case- control study. Thorogood M, Mann J, Murphy M, Vessey M Am J Epidemiol 1992;136:35-45.
  9. Oral contraceptives and cardiovascular risk. Taking a safe course of action. Derman RJ Postgrad Med 1990;88:119-22.
  10. Stroke in users of low-dose oral contraceptives. Petitti DB, Sidney S, Bernstein A, Wolf S, Quesenberry C, Ziel HK N Engl J Med 1996;335:8-15.
  11. Oral contraceptives: a reassessment. Derman R Obstet Gynecol Surv 1989;44:662-8.
  12. Contraception. Mishell DR N Engl J Med 1989;320:777-85.
  13. Oral contraceptives and lipids and lipoproteins: Part I--Variations in mean levels by oral contraceptive type. Burkman RT, Zacur HA, Kimball AW, Kwiterovich P, Bell WR Contraception 1989;40:553-61.
  14. Risk of stroke in users of oral contraceptives. Thorogood M JAMA 1999;281:1255-6.
  15. Long-term health risks and benefits of oral contraceptive use. Peterson HB, Lee NC Obstet Gynecol Clin North Am 1990;17:775-88.
  16. Oral contraceptives and mortality from venous thromboembolism - reply. Vandenbroucke JP, Bloemenkamp KWM, Helmerhorst FM, Rosendaal FR Lancet 1996;348:1096-7.
  17. Oral contraception and risk of a cerebral thromboembolic attack: results of a case-control study. Lidegaard O BMJ 1993;306:956-63.
  18. Oral contraceptives and the risk of DVT. Piegsa K, Guillebaud J Practitioner 1996;240:544.
  19. Benefits and risks of oral contraceptive use. Williams RS Postgrad Med 1992;92:155-7.
  20. Oral contraceptives and venous thromboembolism. Speroff L Int J Gynaecol Obstet 1996;54:45-50.
  21. The safety of oral contraceptives: epidemiologic insights from the first 30 years. Grimes DA Am J Obstet Gynecol 1992;166:1950-4.
  22. Update on the metabolic effects of steroidal contraceptives and their relationship to cardiovascular disease risk. Godsland IF, Crook D Am J Obstet Gynecol 1994;170:1528-36.
  23. Multicenter randomized comparative trial of two low-dose triphasic combined oral contraceptives containing desogestrel or norethindrone. Shoupe D Obstet Gynecol 1994;83:679-85.
  24. Oral contraceptive use and the risk of myocardial infarction. Rosenberg L, Palmer JR, Lesko SM, Shapiro S Am J Epidemiol 1990;131:1009-16.
  25. Evaluation of the prethrombotic state in pregnancy and in women using oral contraceptives. Levine AB, Teppa J, Mcgough B, Cowchock FS Contraception 1996;53:255-7.
  26. Oral contraceptive use and mortality during 12 years of follow-up: the Nurses' Health Study. Colditz GA Ann Intern Med 1994;120:821-6.
  27. Oral contraception: risks and benefits. Steinberg WM Adv Contracept 1989;5:219-28.
  28. Choosing the best oral contraceptive. Stubblefield PG Clin Obstet Gynecol 1989;32:316-28.
  29. Product Information. Yasmin (drospirenone-ethinyl estradiol) Anonymous Berlex Laboratories, Richmond, CA. PROD;
  30. Benefits and risk of oral contraceptives. A reassessment. Burkman RT Jr J Reprod Med 1991;36:217-8.
  31. Idiopathic thromboembolism associated with triphasic oral contraceptives. Miwa LJ, Edmunds AL, Shaefer MS, Raynor SC DICP 1989;23:773-5.
  32. The effect of oestrogen dose and progestogen type on haemostatic changes in women taking low dose oral contraceptives. Norris LA, Bonnar J Br J Obstet Gynaecol 1996;103:261-7.
  33. Oral contraceptives and mortality from venous thromboembolism. Farmer R, Lewis M Lancet 1996;348:1095.
  34. Oral contraceptives, pregnancy and the risk of cerebral thromboembolism: the influence of diabetes, hypertension, migraine and previous thrombotic disease. Lidegaard O Br J Obstet Gynaecol 1995;102:153-9.
  35. Oral contraception and stroke. Evidence from the Royal College of General Practitioners' Oral Contraception Study. Hannaford PC, Croft PR, Kay CR Stroke 1994;25:935-42.
  36. Oral contraceptives and myocardial infarction. Thorneycroft IH Am J Obstet Gynecol 1990;163:1393-7.
Multum version: 146.0 (Oct 22, 2009)
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