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Osphena Warnings and Precautions
It is important for women who have a history of cancer to tell their healthcare provider before starting treatment with Osphena. Certain safety precautions are associated with this drug, including specific warnings for women who have a family history of an estrogen-dependent cancer, those with diabetes, and women who still have their uterus. Review these issues with your healthcare provider to ensure a safe treatment.
You should talk with your healthcare provider prior to taking Osphena™ (ospemifene) if you have:
- Unexplained, abnormal vaginal bleeding
- Cancer or a history of it, including breast cancer or endometrial cancer
- Had breast lumps or an abnormal mammogram
- A blood clot or a history of blood lots
- Had a heart attack, stroke, or mini-stroke (transient ischemic attack, or TIA)
- High blood pressure (hypertension)
- High cholesterol (hypercholesterolemia)
- Diabetes
- Liver disease, such as hepatitis, cirrhosis, or liver failure
- Plans for surgery or will be on bed rest
- A uterus (have not had a hysterectomy)
- Any allergies, including to foods, dyes, or preservatives.
In addition, let your healthcare provider know if you:
- Use tobacco products
- Are overweight
- Are pregnant or thinking of becoming pregnant
- Are breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Written by/reviewed by: Susan Lakey, PharmD, MPH, BCPP
Last reviewed by: Kristi Monson, PharmD