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warnings
WARNINGS 1. The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately. 2. Beagle dogs treated with medroxyprogesterone acetate developed mammary nodules some of which were malignant. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas the nodules in the drug-treated animals were larger, more numerous, persistent, and there were some breast malignancies with metastases. Their significance with respect to humans has not been established. 3. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn. 4. Detectable amounts of progestin have been identified in the milk of mothers receiving the drug. The effect of this on the nursing infant has not been determined. 5. Usage in pregnancy is contraindicated. 6. Retrospective studies of morbidity and mortality in Great Britain and studies of morbidity in the United States have shown a statistically significant association between thrombophlebitis, pulmonary embolism, and cerebral thrombosis and embolism and the use of oral contraceptives. 4-7 The estimate of the relative risk of thromboembolism in the study by Vessey and Doll 6 was about sevenfold, while Sartwell and associates 7 in the United States found a relative risk of 4.4, meaning that the users are several times as likely to undergo thromboembolic disease without evident cause as nonusers. The American study also indicated that the risk did not persist after discontinuation of administration, and that it was not enhanced by long continued administration. The American study was not designed to evaluate a difference between products.
ADVERSE REACTIONS Breast – Breast tenderness or galactorrhea has been reported. Skin – Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported. Thromboembolic Phenomena – Thromboembolic phenomena including thrombophlebitis and pulmonary embolism have been reported. Other – The following adverse reactions have been observed in women taking progestins, including medroxyprogesterone acetate tablets: breakthrough bleeding cholestatic jaundice spotting anaphylactoid change in menstrual flow reactions and anaphylaxis amenorrhea rash (allergic) with edema and without pruritus change in weight mental depression (increase or decrease) pyrexia changes in cervical insomnia erosion and cervical nausea secretions somnolence Although available evidence is suggestive of an association, such a relationship has been neither confirmed nor refuted for the following serious adverse reactions: neuro-ocular lesions, eg, retinal thrombosis and optic neuritis. The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: rise in blood pressure in fatigue susceptible individuals backache premenstrual-like syndrome hirsutism changes in libido loss of scalp hair changes in appetite erythema multiforme cystitis-like syndrome erythema nodosum headache hemorrhagic eruption nervousness itching dizziness Laboratory Tests – The following laboratory results may be altered by the use of estrogen-progestin combination drugs: Increased sulfobromophthalein retention and other hepatic function tests. Coagulation tests: increase in prothrombin factors VII, VIII, IX and X. Metyrapone test. Pregnanediol determination. Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T 3 uptake values.