Combipatch Risks, Warnings, and Complications

CARDIOVASCULAR RISK: There is an increased risk of blood clots (deep vein thrombosis and pulmonary embolism), stroke, and heart attack with estrogen plus progestin therapy. You will need to discontinue the use of Combipatch immediately if you develop these serious complications. 

Give your doctor a complete medical history before starting hormone replacement therapy with Combipatch. Risk factors for cardiovascular disease include hypertension (high blood pressure), diabetes mellitus (high blood sugar), hypercholesterolemia (high blood cholesterol), smoking, obesity, and a personal or family history of venous thromboembolism (blood clots in the legs (DVT) or lungs (PE)). 

You may need to discontinue the use of Combipatch 4-6 weeks before planned surgery, as prolonged immobilization during the postoperative period is associated with an increased risk of venous thromboembolism (VTE).

CANCER RISK

Breast Cancer

The use of combined estrogen and progestin therapy can increase the risk of invasive breast cancer. Studies also suggest that breast cancers are more likely to be larger in size, node-positive, and at a more advanced stage at the time of diagnosis in women who take hormonal therapy. The increase in risk is related to the duration of hormone therapy and can last for up to 10 years after stopping estrogen-progestin combination therapy or estrogen-alone therapy. 

Tell your doctor if you have a personal or family history of breast cancer or abnormal mammograms before starting treatment with Combipatch (estradiol-norethindrone acetate). Your healthcare provider will recommend monthly self-breast examinations and yearly breast examinations by a healthcare provider as well as mammography examinations based on your age and risk factors.

Endometrial Cancer

There is an increased risk of endometrial cancer (cancer of the uterine lining) associated with estrogen therapy. Unopposed estrogen (without progestin) can increase the risk by up to 12 times compared to women who don’t take hormone replacement. The risk depends on the duration of hormone treatment and the estrogen dose. Using estrogens for less than a year does not increase the risk significantly. The highest risk is linked to prolonged use and can be up to 24 times higher after 5-10 years of estrogen therapy. 

The high risk can persist for up to 15 years after estrogen treatment is stopped. There is no evidence that natural estrogens do not carry a similar risk as synthetic estrogens. The addition of progestins to estrogen therapy can lower the risk of endometrial hyperplasia, which may be a precancerous change in the uterine lining.

Your doctor will recommend appropriate clinical surveillance while you are using Combipatch (estrogen-norethindrone acetate). Tell your doctor if you have any abnormal vaginal bleeding. 

Ovarian Cancer

Research suggests that hormone replacement therapy with estrogen plus progestin for menopausal symptoms may result in a small increase in the risk of ovarian cancer. 

RISK OF DEMENTIA: Estrogen plus progestin use in postmenopausal women between 65 and 79 years of age can increase the risk of dementia. It is unclear if dementia risk increases in younger women.

GALLBLADDER DISEASE: Postmenopausal women who receive estrogen have a 2-4 times higher risk of gallbladder problems requiring surgery. 

HYPERCALCEMIA: The use of hormone therapy (estrogen) can lead to severe hypercalcemia (high blood calcium levels) in breast cancer patients who have bone metastases (spread of the breast cancer to bone). 

VISION PROBLEMS: Retinal vascular thrombosis (blood clot in the eye) has been reported in women taking estrogens. Stop using Combipatch immediately and seek emergency medical care if you develop sudden partial or complete vision loss, sudden proptosis (bulging eyes), diplopia (double vision), or migraine headache. 

SEVERE ALLERGIC REACTIONS: Angioedema or swelling of the face, eyes, lips, tongue, throat, fingers, lower legs, or ankles, with or without urticaria (hives) has been reported in people who took estrogens. Seek emergency medical care if you develop these serious symptoms after using Combipatch. Swelling in the throat can cause difficulty breathing and have a fatal outcome. 

There are also reports of anaphylactic and anaphylactoid reactions during Combipatch treatment. Seek emergency medical attention if you develop a rash, hives, itching, blistering, or peeling skin; swelling of the lips, tongue, or throat; trouble breathing; or gastrointestinal symptoms such as stomach pain and vomiting. If you develop an allergic reaction to Combipatch, do not use it again.