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WHAT IS IT?
Depo Provera ("Depo") is a hormonal method of birth control which works by preventing ovulation,
thickening the cervical mucous, and thinning the lining of the uterus. Depo Provera contains
medroxyprogesterone acetate, a chemical similar to the natural hormone progesterone that is produced by a
woman's ovaries. It is given by injection once every 12 weeks and is more than 99 percent effective in
preventing pregnancy. WHO CAN USE IT?
Because Depo does not contain estrogen, it is considered safe for many women who cannot use birth control
pills. For instance, women who smoke, have high blood pressure, high cholesterol, headaches, or leg pain
can use Depo. Women with a history of diabetes, seizures, or blood clots may also be able to use this
method. Unlike other hormonal birth control methods, Depo is safe for women who have just had a baby and
women who are breast feeding. WHO SHOULD NOT USE IT?
Certain women should not use Depo. Please let your provider know if:
You think you might be pregnant You have any vaginal bleeding without a known reason You have had cancer of the breast You have had a stroke You have or have had blood clots in your legs You have problems with your liver You are allergic to Depo-Provera
You are planning a pregnancy within the next 2 years (It usually takes from 4 to 31 months
after ending Depo use to return to fertility, regardless of how long a woman has used Depo.)
You have an increased risk of fracture and/or low bone mass based on results of your recent
HOW IS IT USED?
The first shot is given within the first 5 days of a menstrual cycle (5 days from the first day of bleeding).
Subsequent injections are given every 12 weeks. You do not need to use a back up method of birth control
as long as you have received your Depo injections as above. If a Depo Provera user does not return for
subsequent shots, she must use another method of birth control to prevent pregnancy.
WHAT ARE THE POSSIBLE SIDE EFFECTS?
The most common side effect is irregular bleeding including spotting, more frequent bleeding or no bleeding
at all. With continued use bleeding usually decreases and many women stop having periods completely. It is
normal to have unpredictable bleeding while taking this medication. Any woman uncomfortable with varying
cycles may want to consider another method.
Depo use may also cause a delay in return to fertility. It may take up to 2 years to become pregnant after
stopping the shots. However, most women can conceive within 12 months. In addition, two-thirds of women
using Depo in the clinical trials experienced weight gain of approximately 5 lbs. in the first year. Many
continued to gain weight at the rate of about 3 pounds each year after the first year. Also, Depo Provera
may cause a reduction in HDL ("good" cholesterol) levels. BMC may require a baseline lipid panel before
the first injection.
Uncommon but potential side effects include: breast tenderness, mood changes, decreased sex drive, pelvic
pain, backache, leg cramps, headaches, abdominal cramps, dizziness, weakness or fatigue, vaginal discharge
or irritation, swelling of hands and feet, acne, hair loss, rash, hot flashes, or joint pain.
Studies show a possible slight increase in the risk of breast cancer among Depo users. This increase is not
associated with long-term use and the likelihood of developing breast cancer is small even among users at
greatest risk (strong family history, high fat diet etc.).
Depo Provera use may also cause a decrease in bone minerals. This decrease in minerals may increase a
woman's risk of developing bone fractures. With adequate calcium and vitamin D intake, and participation in
a weight bearing exercise program, women may recover their bone minerals when Depo is stopped.
The following are considered WARNING SIGNS
of more severe side effects:
severe lower abdominal pain
prolonged heavy vaginal bleeding
migraine or severe headaches
severe pain, swelling or numbness in arms or legs
shortness of breath or sharp chest pain
vision problems or dizziness
swelling or redness at the injection site
Depo users experiencing any of these symptoms should contact the Clinic as soon as possible. BMC has a
24 hour emergency service accessible through 721-1646 or 800-727-2546. WHAT ARE THE BENEFITS?
Depo Provera is highly effective in the prevention of pregnancy (99.7%). Some women also experience
decreased menstrual cramps, blood flow, and premenstrual symptoms. Depo may be used by breast feeding
women and may increase the length of time a woman is able to produce milk.
Depo Provera is not a barrier form of birth control and therefore does not protect against sexually transmitted
diseases (STDs) including HIV. Safer sex is encouraged by using a barrier method of birth control such as
Procedural steps taken and scientific information after the authorisation MAJOR CHANGES1 Commission Product issued on Decision Information affected2 amended on The DDPS has been updated to version 5.2 to reflect the change of the Qualified Person for Pharmacovigilance (QPPV) as well as to notify other changes to the DDPS performed since the last approved versi
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