Synopsis of Prescription Drug Litigation
Wyeth, maker of the number one selling hormone replacement therapy Prempro, has experienced a 24% stock tumble after news that the large hormone replacement therapy study was halted because of the risk of heart disease, breast cancer, endometrial cancer, strokes, and blood clots found in healthy women on the estrogen and progestin combination. Their stock decline may indicate only the beginning of their troubles as women are scrambling to seek compensation for the injuries they are claiming to have suffered in filing hormone replacement therapy and Prempro lawsuits.
About six million American women use Prempro. Prempro is similar to other drug manufacturer's hormone replacement therapy drugs that have been used for fifty years. It was originally thought that Prempro and other hormone replacement therapy options protect against heart disease and osteoporosis and to help treat symptoms of menopause. The large federal study found that instead Prempro hormone replacement therapy increases the incidence of breast cancer by 26%, heart attacks by 29%, strokes by 41%, and double the amount of blood clots in the legs and veins.
Prempro® and Premphase® (conjugated estrogens and medroxyprogesterone acetate): Prempro is manufactured by Wyeth and approved by the FDA in 1995, Premphase is manufactured by Pfizer and also approved by the FDA in 1995.
Why is this medication prescribed?: Combinations of estrogen and progestin are used to treat certain symptoms of menopause. Estrogen and progestin are two female sex hormones. Hormone replacement therapy works by replacing estrogen hormone that is no longer being made by the body. Estrogen reduces feelings of warmth in the upper body and periods of sweating and heat (hot flashes), vaginal symptoms (itching, burning, and dryness) and difficulty with urination, but it does not relieve other symptoms of menopause such as nervousness or depression. Estrogen also prevents thinning of the bones (osteoporosis) in menopausal women. Progestin is added to estrogen in hormone replacement therapy to reduce the risk of uterine cancer in women who still have their uterus.
FDA indications:
PREMPRO or PREMPHASE therapy is indicated in women who have a uterus for the:
1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
3. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL STUDIES.)
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing
exercise, adequate calcium and Vitamin D intake, and when indicated, pharmacologic therapy.Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
What you should know before taking Prempro or Premphase
Before taking hormone replacement therapy, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully.
Keep all appointments with your doctor and the laboratory. You should have a complete physical exam, including blood pressure measurements, breast and pelvic exams, and a Pap test at least yearly. Follow your doctor's directions for examining your breasts; report any lumps immediately.
If you are taking hormone replacement therapy to treat symptoms of menopause, your doctor will check every 3 to 6 months to see if you still need this medication. If you are taking this medication to prevent thinning of the bones (osteoporosis), you will take it for a longer period of time.
Before you have any laboratory tests, tell the laboratory personnel that you take hormone replacement therapy, because this medication may interfere with some laboratory tests.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
What special precautions should I follow?:
- tell your doctor and pharmacist if you are allergic to estrogen, progestin, or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: acetaminophen (Tylenol); anticoagulants ('blood thinners') such as warfarin (Coumadin); cyclosporine (Neoral, Sandimmune); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), and phenytoin (Dilantin); morphine (Kadian, MS Contin, MSIR, others); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone) and prednisolone (Prelone); rifampin (Rifadin, Rimactane); salicylic acid; temazepam (Restoril); theophylline (Theobid, Theo-Dur); and thyroid medication such as levothyroxine (Levothroid, Levoxyl, Synthroid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have had a hysterectomy and if you have or have ever had asthma; toxemia (high blood pressure during pregnancy); depression; epilepsy (seizures); migraine headaches; liver, heart, gallbladder, or kidney disease; jaundice (yellowing of the skin or eyes); vaginal bleeding between menstrual periods; and excessive weight gain and fluid retention (bloating) during the menstrual cycle.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor immediately. Estrogen and progestin may harm the fetus.
- if you are having surgery, including dental surgery, tell the doctor or dentist you are taking hormone replacement therapy.
- tell your doctor if you smoke cigarettes. Smoking while taking this medication may increase your risk of serious side effects such as blood clots and stroke. Smoking also may decrease the effectiveness of this medication.
- tell your doctor and pharmacist if you wear contact lenses. If you notice changes in vision or ability to wear your lenses while taking hormone replacement therapy, see an eye doctor.
Black Box Warning:
What is the most important information I should know about PREMPRO and PREMPHASE (combinations of estrogens and a progestin)?
- Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function)
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older
- Do not use estrogen-alone to prevent heart disease, heart attacks, or dementia
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb)
- Using estrogen-alone may increase your chances of getting strokes or blood clots
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years or older
- You and your healthcare provider should talk regularly about whether you still need treatment with PREMPRO or PREMPHASE
Lawsuits:
When to call the Venardi Law Firm: If you have received hormone replacement therapy (HRT) with drugs like Prempro and Premphase and suffered from adverse side effects, it is pertinent that you contact a hormone replacement therapy side effects lawyer like the Venardi Law Firm.
The increased risk of hormone replacement therapy adverse side effects in pills like Prempro and Premphase include:
Heart Disease
The Women's Health Initiative study showed that estrogen/progestin hormones do not protect against heart disease as earlier thought. The study found that hormone replacement therapy side effects actually raises the risk of heart disease by 23%.
Breast Cancer
The Women's Health Initiative definitively proved that hormone replacement therapy side effects raise the risk of invasive breast cancer. The earlier thirty studies were unable to prove this serious risk of hormone replacement therapy side effects that were shown to occur 26% more in women taking the pills.
Stroke
Strokes due to blood clots become more likely as people age and as their blood vessels age as well. When blood vessels age they become less flexible and can lead to buildup in blood pressure that causes strokes. Hormone replacement therapy side effects increases a woman's risk of blood clots because estrogen tends to promote them. The blood clots can add to the risk of stroke that was found to occur 38% more in women experiencing hormone replacement therapy side effects.
