Depo-Provera is an injectable contraceptive used to prevent pregnancy. Part of a class of medications called "progestins," Depo-Provera works by preventing ovulation (the release of eggs from the ovaries), and by thinning the uterine lining. The U.S. Food and Drug Administration (FDA) approved Depo-Provera in 1992.
While Depo-Provera acts as birth control, it does not prevent the spread of the human immunodeficiency virus (HIV) or other sexually transmitted diseases (STDs).
Depo-Provera FDA Alert
In November 2004, the FDA announced that a "black box" warning would be added to the labeling of Depo-Provera Contraceptive Injection. The label warns Depo-Provera users that prolonged use may result in the loss of bone density, and that the loss may be greater the longer the drug is administered. This bone density loss may not be completely reversible after discontinuation of Depo-Provera use. The warning goes on to state that a woman should only use Depo-Provera Contraceptive Injection as a long-term birth control method (e.g., longer than two years) if other birth control methods prove inadequate.
In addition to the black box warning, Depo-Provera manufacturer Pfizer issued a "Dear Healthcare Professional" letter regarding the effect of long-term treatment on bone mineral density, and incorporated the new information into the patient information sheet distributed with Depo-Provera.
What Should I Know Before Using Depo-Provera?
A health care provider in an office or clinic usually administers Depo-Provera. You should work with your healthcare provider to ensure that there's no possibility of pregnancy when beginning the medication. Women who have been taking another form of birth control will also have to work with their healthcare provider to determine when to start taking Depo-Provera.
Your menstrual cycle will probably change after you start using Depo-Provera. Women commonly experience irregular periods and spotting while using the drug. These changes are a natural result of the medication, and should disappear once you stop taking the drug.
Depo-Provera is a long-term birth control solution. As a result, it may take some time to become pregnant even after your last injection. Your healthcare professional can offer advice on how Depo-Provera can affect near-term plans to become pregnant.
Patients taking Depo-Provera should undergo a complete physical at least once a year. This should include measuring blood pressure, a breast and pelvic examination, and a pap test. Patients should also regularly monitor their breasts and immediately report any lumps. In addition, if you undergo any laboratory tests you should inform the relevant personnel that you are taking Depo-Provera.
Depo-Provera Health Risks
You should be aware of some health risks associated with taking Depo-Provera. Women who are under the age of 35 and who began taking the drug in the last five years may face a slightly higher risk of developing breast cancer. There's also a risk of patients developing blood clots, which can potentially lead to a pulmonary embolism or stroke.
Side Effects of Depo-Provera Use
Patients taking Depo-Provera have reported experiencing the following side effects:
- Changes in menstrual periods
- Weight gain
- Difficulty falling asleep or staying asleep
- Hot flashes
- Breast pain, swelling, or tenderness
- Stomach cramps or bloating
- Leg cramps
- Back or joint pain
- Loss of hair on scalp
- Swelling, redness, irritation, burning, or itching of the vagina
- White vaginal discharge
- Changes in sexual desire
- Cold or flu symptoms
- Pain, irritation, lumps, redness or scarring in the place where the medication was injected
Other less common, but potentially serious side effects include:
- Sudden shortness of breath
- Sudden sharp or crushing chest pain
- Coughing up blood
- Severe headache
- Upset stomach
- Dizziness or faintness
- Change or loss of vision
- Double vision
- Bulging eyes
- Difficulty speaking
- Weakness or numbness in an arm or leg
- Yellowing of the skin or eyes
- Extreme tiredness
- Pain, swelling, warmth, redness, or tenderness in one leg only
- Menstrual bleeding that is heavier or lasts longer than normal
- Severe pain or tenderness just below the waist
- Difficulty breathing or swallowing
- Swelling of the hands, feet, ankles, or lower legs
- Difficult, painful, or frequent urination
- Constant pain, pus, warmth, swelling, or bleeding in the place where the medication was injected
Special Dietary Instructions
Patients taking Depo-Provera are encouraged to consume foods containing calcium and Vitamin D. This can help prevent a calcium deficiency in the bones. Some patients choose to take calcium and Vitamin D supplements instead. A healthcare provider or nutritionist could help you adjust your diet.
Have an Attorney Help With Your Depo-Provera Claim
While all medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible for any injuries that result from the product defect. Get legal help today by contacting an experienced product liability attorney.
Contact a qualified product liability attorney to make sure your rights are protected.