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warnings and cautions
5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders: Discontinue Medroxyprogesterone Acetate Injectable Suspension, USP in patients who develop thrombosis ( 5.2 ) Cancer Risks: Monitor women with breast nodules or a strong family history of breast cancer carefully. ( 5.3 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Medroxyprogesterone Acetate Injectable Suspension, USP becomes pregnant or complains of severe abdominal pain. ( 5.4 ) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. ( 5.5 ) Liver Function: Discontinue Medroxyprogesterone Acetate Injectable Suspension, USP if jaundice or disturbances of liver function develop ( 5.6 ) Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.11 ) 5.1 Loss of Bone Mineral Density Use of Medroxyprogesterone Acetate Injectable Suspension, USP reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of Medroxyprogesterone Acetate Injectable Suspension, USP by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. After discontinuing Medroxyprogesterone Acetate Injectable Suspension, USP in adolescents, mean BMD loss at total hip and femoral neck did not fully recover by 60 months (240 weeks) post-treatment [see Clinical Studies (14.3) ]. Similarly, in adults, there was only partial recovery of mean BMD at total hip, femoral neck and lumbar spine towards baseline by 24 months post-treatment. [ See Clinical Studies (14.2) .] Medroxyprogesterone Acetate Injectable Suspension, USP should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate. BMD should be evaluated when a woman needs to continue to use Medroxyprogesterone Acetate Injectable Suspension, USP long-term. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. Other birth control methods should be considered in the risk/benefit analysis for the use of Medroxyprogesterone Acetate Injectable Suspension, USP in women with osteoporosis risk factors. Medroxyprogesterone Acetate Injectable Suspension, USP can pose an additional risk in patients with risk factors for osteoporosis (e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids). Although there are no studies addressing whether calcium and Vitamin D may lessen BMD loss in women using Medroxyprogesterone Acetate Injectable Suspension, USP, all patients should have adequate calcium and Vitamin D intake. 5.2 Thromboembolic Disorders There have been reports of serious thrombotic events in women using Medroxyprogesterone Acetate Injectable Suspension, USP. However, Medroxyprogesterone Acetate Injectable Suspension, USP has not been causally associated with the induction of thrombotic or thromboembolic disorders. Any patient who develops thrombosis while undergoing therapy with Medroxyprogesterone Acetate Injectable Suspension, USP should discontinue treatment unless she has no other acceptable options for birth control. Do not re-administer Medroxyprogesterone Acetate Injectable Suspension, USP pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. Do not re-administer if examination reveals papilledema or retinal vascular lesions. 5.3 Cancer Risks Breast Cancer Women who currently have or have had breast cancer should not use hormone contraceptives, including Medroxyprogesterone Acetate Injectable Suspension, USP, because breast cancer may be hormonally sensitive. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care. A pooled analysis from two case-control studies, the World Health Organization Study and the New Zealand Study, reported the relative risk (RR) of breast cancer for women who had ever used Medroxyprogesterone Acetate Injectable Suspension, USP as 1.1 (95% confidence interval [CI] 0.97 to 1.4). Overall, there was no increase in risk with increasing duration of use of Medroxyprogesterone Acetate Injectable Suspension, USP. The RR of breast cancer for women of all ages who had initiated use of Medroxyprogesterone Acetate Injectable Suspension, USP within the previous 5 years was estimated to be 2.0 (95% CI 1.5 to 2.8). The World Health Organization Study, a component of the pooled analysis described above, showed an increased RR of 2.19 (95% CI 1.23 to 3.89) of breast cancer associated with use of Medroxyprogesterone Acetate Injectable Suspension, USP in women whose first exposure to drug was within the previous 4 years and who were under 35 years of age. However, the overall RR for ever-users of Medroxyprogesterone Acetate Injectable Suspension, USP was 1.2 (95% CI 0.96 to 1.52). The National Cancer Institute reports an average annual incidence rate for breast cancer for US women, all races, age 15 to 34 years of 8.7 per 100,000. A RR of 2.19, thus, increases the possible risk from 8.7 to 19.0 cases per 100,000 women. The attributable risk, thus, is 31.8 per 100,000 women per year. Cervical Cancer A statistically nonsignificant increase in RR estimates of invasive squamous-cell cervical cancer has been associated with the use of Medroxyprogesterone Acetate Injectable Suspension, USP in women who were first exposed before the age of 35 years (RR 1.22 to 1.28 and 95% CI 0.93 to 1.70). The overall, nonsignificant relative rate of invasive squamous-cell cervical cancer in women who ever used Medroxyprogesterone Acetate Injectable Suspension, USP was estimated to be 1.11 (95% CI 0.96 to 1.29). No trends in risk with duration of use or times since initial or most recent exposure were observed. Other Cancers Long-term case-controlled surveillance of users of Medroxyprogesterone Acetate Injectable Suspension, USP found no overall increased risk of ovarian or liver cancer. 5.4 Ectopic Pregnancy Be alert to the possibility of an ectopic pregnancy among women using Medroxyprogesterone Acetate Injectable Suspension, USP who become pregnant or complain of severe abdominal pain. 5.5 Anaphylaxis and Anaphylactoid Reaction Anaphylaxis and anaphylactoid reaction have been reported with the use of Medroxyprogesterone Acetate Injectable Suspension, USP. Institute emergency medical treatment if an anaphylactic reaction occurs. 5.6 Liver Function Discontinue Medroxyprogesterone Acetate Injectable Suspension, USP use if jaundice or acute or chronic disturbances of liver function develop. Do not resume use until markers of liver function return to normal and Medroxyprogesterone Acetate Injectable Suspension, USP causation has been excluded. 5.7 Convulsions There have been a few reported cases of convulsions in patients who were treated with Medroxyprogesterone Acetate Injectable Suspension, USP. Association with drug use or pre-existing conditions is not clear. 5.8 Depression Monitor patients who have a history of depression and do not readminister Medroxyprogesterone Acetate Injectable Suspension, USP if depression recurs. 5.9 Bleeding Irregularities Most women using Medroxyprogesterone Acetate Injectable Suspension, USP experience disruption of menstrual bleeding patterns. Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding. Rule out the possibility of organic pathology if abnormal bleeding persists or is severe, and institute appropriate treatment. As women continue using Medroxyprogesterone Acetate Injectable Suspension, USP, fewer experience irregular bleeding and more experience amenorrhea. In clinical studies of Medroxyprogesterone Acetate Injectable Suspension, USP, by month 12 amenorrhea was reported by 55% of women, and by month 24, amenorrhea was reported by 68% of women using Medroxyprogesterone Acetate Injectable Suspension, USP. 5.10 Weight Gain Women tend to gain weight while on therapy with Medroxyprogesterone Acetate Injectable Suspension, USP. From an initial average body weight of 136 lb, women who completed 1 year of therapy with Medroxyprogesterone Acetate Injectable Suspension, USP gained an average of 5.4 lb. Women who completed 2 years of therapy gained an average of 8.1 lb. Women who completed 4 years gained an average of 13.8 lb. Women who completed 6 years gained an average of 16.5 lb. Two percent of women withdrew from a large-scale clinical trial because of excessive weight gain. 5.11 Carbohydrate Metabolism A decrease in glucose tolerance has been observed in some patients on Medroxyprogesterone Acetate Injectable Suspension, USP treatment. Monitor diabetic patients carefully while receiving Medroxyprogesterone Acetate Injectable Suspension, USP. 5.12 Lactation Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone Acetate Injectable Suspension, USP. In nursing mothers treated with Medroxyprogesterone Acetate Injectable Suspension, USP, milk composition, quality, and amount are not adversely affected. Neonates and infants exposed to medroxyprogesterone from breast milk have been studied for developmental and behavioral effects through puberty. No adverse effects have been noted. 5.13 Fluid Retention Because progestational drugs including Medroxyprogesterone Acetate Injectable Suspension, USP may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction. 5.14 Return of Fertility Return to ovulation and fertility is likely to be delayed after stopping Medroxyprogesterone Acetate Injectable Suspension, USP. In a large US study of women who discontinued use of Medroxyprogesterone Acetate Injectable Suspension, USP to become pregnant, data are available for 61% of them. Of the 188 women who discontinued the study to become pregnant, 114 became pregnant. Based on Life-Table analysis of these data, it is expected that 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection. The median time to conception for those who do conceive is 10 months following the last injection with a range of 4 to 31 months, and is unrelated to the duration of use. No data are available for 39% of the patients who discontinued Medroxyprogesterone Acetate Injectable Suspension, USP to become pregnant and who were lost to follow-up or changed their mind. 5.15 Sexually Transmitted Diseases Patients should be counseled that Medroxyprogesterone Acetate Injectable Suspension, USP does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 5.16 Pregnancy Although Medroxyprogesterone Acetate Injectable Suspension, USP should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy. Neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development. 5.17 Monitoring A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare. 5.18 Interference with Laboratory Tests The use of Medroxyprogesterone Acetate Injectable Suspension, USP may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. [See Drug Interactions (7.2) ].