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Medroxyprogesterone is a prescription medication that contains a synthetic form of the female hormone progesterone.[1] It is one of the top 200 prescribed drugs in the U.S.,[2] most commonly used for contraception and hormone therapy in women.[3]
The drug is available in a low-dose oral formulation (PROVERA) that is taken for a number of days per month.[4] It also is available in two high-dose injectable formulations: DEPO-PROVERA (which is injected into the muscle no more than once...
Medroxyprogesterone is a prescription medication that contains a synthetic form of the female hormone progesterone.[1] It is one of the top 200 prescribed drugs in the U.S.,[2] most commonly used for contraception and hormone therapy in women.[3]
The drug is available in a low-dose oral formulation (PROVERA) that is taken for a number of days per month.[4] It also is available in two high-dose injectable formulations: DEPO-PROVERA (which is injected into the muscle no more than once per week)[5] and DEPO-SUBQ PROVERA 104 (which is injected under the skin every three months).[6]
Both Depo-subQ Provera 104 and Depo-Provera prevent ovulation in women, but Provera does not do so when used at the recommended dose.[7]
Provera is approved by the Food and Drug Administration (FDA) for three uses: (1) treating amenorrhea (absence of menstrual periods) in women with a hormonal imbalance who previously had regular menstrual cycles but have not had a period for several months, (2) treating abnormal uterine bleeding due to hormonal imbalance in the absence of gynecological disorders such as fibroids or cancer of the uterus, and (3) preventing endometrial hyperplasia (thickening of the inner lining of the uterus) in postmenopausal women with intact uteruses who also are taking conjugated estrogens to reduce the risk of endometrial cancer.
Depo-Provera is approved only as an add-on or a palliative therapy for inoperable, recurrent and metastatic cancer of the endometrium or kidney cancer.
Depo-subQ Provera 104 is approved for two uses: (1) preventing pregnancy in women of childbearing potential and (2) managing pain associated with endometriosis (chronic inflammatory disorder in which tissue that normally lines the uterus grows elsewhere in the abdomen, resulting in pain and infertility).
Public Citizen’s Health Research Group classifies Depo-subQ Provera 104 as Do Not Use for contraception and pain associated with endometriosis because the drug causes loss of bone mineral density, an adverse effect that does not occur with other treatment options, and also was shown to cause breast and uterine cancer in animals.
We recommend using the lowest effective dose of the Provera formulation for the shortest possible duration to avoid long-term complications (see text box on page x).
Use in hormone therapy
Conjugated estrogen and medroxyprogesterone (PREMPHASE, PREMPRO) is approved for relieving menopausal symptoms (including hot flashes and night sweats), treatment of vaginal or vulvar atrophy, and prevention (but not treatment) of osteoporosis.[8]
This drug combination has not been approved for the prevention of chronic diseases. Moreover, it increases the risk of cardiovascular disease in postmenopausal women[9] (see text box below).
Cardiovascular disease and probable dementia (Provera)
Medroxyprogesterone (in combination with conjugated estrogen) should not be used to prevent cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported an increased risk of deep vein thrombosis (a blood clot in a large vein, usually in the leg), heart attack, pulmonary embolism (a clot lodged in a blood vessel in the lungs) and stroke in postmenopausal women aged 70 to 79 years who took the aforementioned combination on a daily basis for six years compared with those who took a placebo. The study also reported an increased risk of developing probable dementia in postmenopausal women aged 65 or older who took this combination for four years compared with those who took a placebo.
Breast cancer (Provera)
The WHI study linked the use of medroxyprogesterone (in combination with conjugated estrogen) to an increased risk of invasive breast cancer.
Dose and duration (Provera)
To avoid long-term adverse effects, medroxyprogesterone with estrogen therapy should be used at the lowest effective dose for the shortest possible duration consistent with treatment goals and risks for individual women.
Loss of bone mineral density (Depo-subQ Provera 104)
Women who use Depo-subQ Provera 104 may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible after the drug is discontinued. It is unknown if the use of medroxyprogesterone for contraception during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk of osteoporotic fracture later in life.
Depo-subQ Provera 104 should not be used as a long-term (more than two years) birth control method unless other birth control methods are considered inadequate.
Counseling regarding sexually transmitted infections (Depo-subQ Provera 104)
Women should be counseled that Depo-subQ Provera 104 does not protect against HIV or other sexually transmitted infections.
*These warnings are paraphrased from the FDA-approved drug labeling.
Adverse effects of Provera[10]
Provera can cause numerous adverse effects, including the following:
- Acne, alopecia (hair loss) or unwanted hair growth
- Breast pain or tenderness and inappropriate milk production
- Changes in cervical secretions; change in menstrual flow; decreased, increased or irregular vaginal bleeding; no menstruation; or spotting
- Blood clot in the retina or inflammation of the optic nerve
- Hypersensitivity reactions, including anaphylaxis, angioedema (swelling of the mouth and throat which may interfere with breathing), allergic rash with or without itching and swelling
- Decreased or increased body weight and fluid retention
- Elevated body temperature
- Fatigue
- High blood glucose levels
- Depression, dizziness, headache, insomnia and nervousness
- Nausea and yellow discoloration of the eyes
Some of these adverse effects can occur with Depo-Provera and Depo-subQ Provera 104.
What You Can Do
If you are a woman who is looking into contraceptive methods or if you have endometriosis-related pain, you should not use Depo-subQ Provera 104 or any other medroxyprogesterone formulation because safer treatment alternatives that do not cause loss of bone density are available.
If your doctor prescribes Provera for an approved use or prescribes short-term conjugated estrogen with medroxyprogesterone to control postmenopausal symptoms, ask him or her to prescribe the lowest effective dose for the shortest possible duration. Do not use any medroxyprogesterone-containing drug to prevent or treat chronic diseases, including osteoporosis.
Tell your doctor if you have any of the following conditions before taking Provera or any other medroxyprogesterone formulations: asthma, blood clots, abnormal breast exam or breast cancer, depression, diabetes, endometriosis, heart disease (such as chest pain, heart failure and high blood pressure), high blood calcium levels, kidney disease, liver disease, migraine, pregnancy, seizures, stroke, thyroid disease, osteoporosis (brittle bones), tobacco use or unusual vaginal bleeding.
References
[1]Pharmacia and Upjohn Company LLC. Label: medroxyprogesterone (PROVERA). August 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a586be28-96af-4fed-a13f-9b94fd4c7405. Accessed July 10, 2018.
[2]Symphony Health. Top 200 drugs – 2016. https://symphonyhealth.com/wp-content/uploads/2017/04/Top-200-Drug-List-2016.pdf. Accessed July 10, 2018.
[3]Stanczyk FZ, Bhavnani BR. Reprint of “Use of medroxyprogesterone acetate for hormone therapy in postmenopausal women: Is it safe?” J Steroid Biochem Mol Biol. 2015;153(Sep):151-159.
[4]Pharmacia and Upjohn Company LLC. Label: medroxyprogesterone (PROVERA). August 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a586be28-96af-4fed-a13f-9b94fd4c7405. Accessed July 10, 2018.
[5]Pharmacia and Upjohn Company LLC. Label: medroxyprogesterone (DEPO-PROVERA). August 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0ceb4952-5af3-4b80-b8b5-cea4e9a5486d. Accessed July 10, 2018.
[6]Pharmacia and Upjohn Company LLC. Label: medroxyprogesterone (DEPO-SUBQ PROVERA). December 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=390087a6-f3c3-4f0b-a930-79acf412f153. Accessed July 10, 2018.
[7]Pharmacia and Upjohn Company LLC. Label: medroxyprogesterone (PROVERA). August 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a586be28-96af-4fed-a13f-9b94fd4c7405. Accessed July 10, 2018.
[8]Wyeth Pharmaceuticals Inc. Label: conjugated estrogens and medroxyprogesterone (PREMPHASE). January 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fd0c0836-5d23-2183-da81-9dc7f4287052. Accessed July 10, 2018.
[9]Boardman HMP, Hartley L, Eisinga A, et al. Hormone therapy for preventing cardiovascular disease in post-menopausal women (review). Cochrane Database Syst Rev. 2015;(3):CD002229.
[10]Pharmacia and Upjohn Company LLC. Label: medroxyprogesterone (PROVERA). August 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a586be28-96af-4fed-a13f-9b94fd4c7405. Accessed July 10, 2018.
