Bone Loss and Osteoporosis

Estrogen plays an important role in a woman’s bone health throughout her life. Estrogen loss at menopause is linked to rapid loss of bone mass: In fact, up to 20% of a woman’s bone mass can be lost in the first 5 to 7 years after menopause. This bone loss can lead to the disease osteoporosis.1,16,17

In osteoporosis, bones become less dense and weak, and the result is an increased risk of fractures. It is a “silent disease” because it shows no symptoms. Some women may not even know they have osteoporosis until they fall and break a bone.1,18

Eighty percent of patients with osteoporosis are women. That’s why it’s extremely important to talk to your healthcare professional and learn what steps you can take to protect your bone health after menopause.17

This information is being provided for educational purposes. Please remember, Divigel® has not been studied as a drug to prevent osteoporosis and is not intended for or approved by the FDA for the prevention of osteoporosis or for protection against bone loss.2

There are a number of options available for the prevention of bone loss, so talk to your healthcare professional about which one is best for your individual needs.

Important Safety Information for Patients

The following are not all the possible risks for Divigel®. Please read the full Patient Information leaflet and talk to your healthcare provider.

Estrogens increase the chance of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.

Do not use estrogens, with or without progestins, to prevent heart disease, heart attacks, or strokes. Using estrogens, with or without progestins, may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots.

Do not use estrogens, with or without progestins, to prevent dementia. Using estrogens, with or without progestins, may increase your risk of dementia.

Do not use estrogen products, including Divigel®, if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to any Divigel® ingredients, or think you may be pregnant.

The most common side effects for all estrogen products are headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps and bloating, nausea and vomiting, and hair loss. The less common but serious side effects include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and ovarian cancer.

In Divigel® clinical trials, the most common side effects were inflammation of the nasal passages and pharynx, upper respiratory tract infection, vaginal yeast infection, breast tenderness and vaginal bleeding. Call your healthcare provider right away if you have any symptoms that concern you.

Estrogen products should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly about whether you still need treatment with Divigel®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-654-2299.