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boxed warning
WARNING: LOSS OF BONE MINERAL DENSITY • Women who use Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible [see Warnings and Precautions (5.1) ] . • It is unknown if use of MPA Injectable Suspension, USP during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life [see Warnings and Precautions (5.1) ] . • MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Indications and Usage (1) and Warnings and Precautions (5.1) ] . WARNING: LOSS OF BONE MINERAL DENSITY See full prescribing information for complete boxed warning . • Women who use Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. ( 5.1 ) • It is unknown if use of MPA Injectable Suspension, USP during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. ( 5.1 ) • MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. ( 1 , 5.1 )
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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Thromboembolic Disorders: Discontinue MPA Injectable Suspension, USP in patients who develop thrombosis. ( 5.2 ) • Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) • Meningioma: Discontinue MPA Injectable Suspension, USP if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. ( 5.4 ) • Ectopic Pregnancy: Consider ectopic pregnancy if a woman using MPA Injectable Suspension, USP becomes pregnant or complains of severe abdominal pain. ( 5.5 ) • Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. ( 5.6 ) • Liver Function: Discontinue MPA Injectable Suspension, USP if jaundice or disturbances of liver function develop. ( 5.8 ) • Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.13 ) 5.1 Loss of Bone Mineral Density Use of MPA 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 MPA Injectable Suspension, USP by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. A study to assess the reversibility of loss of BMD in adolescents was conducted with MPA Injectable Suspension, USP. After discontinuing MPA Injectable Suspension, USP in these adolescents, mean BMD loss at the total hip and femoral neck did not fully recover by 5 years (60 months) post-treatment in the sub-group of adolescents who were treated for more than 2 years [see Clinical Studies (14.3) ]. Similarly, in adults, there was only partial recovery of mean BMD at the total hip, femoral neck, and lumbar spine towards baseline by 2 years post-treatment [see Clinical Studies (14.2) ]. The use of MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. BMD should be evaluated when a woman needs to continue to use MPA 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 MPA Injectable Suspension, USP in women with os...
warnings and cautions table
Odds ratio estimates were adjusted for the following covariates: Lee et al. (1987): age, parity, and socioeconomic status. Paul et al. (1989): age, parity, ethnic group, and year of interview. WHO (1991): age, center, and age at first live birth. Shapiro et al. (2000): age, ethnic group, socioeconomic status, and any combined estrogen/progestogen oral contraceptive use. Li et al. (2012): age, year, BMI, duration of OC use, number of full-term pregnancies, family history of breast cancer, and history of screening mammography.
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adverse reactions
6 ADVERSE REACTIONS The following important adverse reactions observed with the use of MPA Injectable Suspension, USP are discussed in greater detail in the Warnings and Precautions section (5) : • Loss of Bone Mineral Density [see Warnings and Precautions (5.1) ] • Thromboembolic disease [see Warnings and Precautions (5.2) ] • Breast Cancer [see Warnings and Precautions (5.3) ] • Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions (5.6) ] • Bleeding Irregularities [see Warnings and Precautions (5.11) ] • Weight Gain [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence >5%): menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lb at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Clinical trials are conducted under widely varying conditions, therefore, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the two clinical trials with MPA Injectable Suspension, USP, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of MPA Injectable Suspension, USP. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg MPA Injectable Suspension, USP every 3-months (90 days). The median study duration was 13 months with a range of 1‑84 months. Fifty‑eight percent of patients remained in the study after 13 months and 34% after 24 months. Table 1. Adverse Reactions that Were Reported by More than 5% of Subjects Body System Body System represented from COSTART medical dictionary. Adverse Reactions [Incidence (%)] Body as a Whole Headache (16.5%) Abdominal pain/discomfort (11.2%) Metabolic/Nutritional Increased weight >10 lb at 24 months (37.7%) Nervous Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%) Reproductive (Urogenital ) Menstrual irregularities: bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% a...
adverse reactions table
Table 1. Adverse Reactions that Were Reported by More than 5% of Subjects Body SystemBody System represented from COSTART medical dictionary. Adverse Reactions [Incidence (%)] Body as a Whole Headache (16.5%) Abdominal pain/discomfort (11.2%) Metabolic/Nutritional Increased weight >10 lb at 24 months (37.7%) Nervous Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%) Reproductive (Urogenital) Menstrual irregularities: bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months)