Drug Uses

Evista is a prescription medicine used by women after menopause to treat or prevent a condition called osteoporosis. You should take calcium and vitamin D along with Evista if you do not get enough calcium and vitamin D in your diet.

How Taken

The recommended dosage is one 60-mg Evista tablet daily, which may be administered any time of day without regard to meals.

Warnings/Precautions

Before taking this medication, tell your doctor if you have a history of blood clots; stroke; cancer; increased triglycerides (a type of fat in the blood); or liver disease. You may not be able to take Evista, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Evista is in the FDA pregnancy category X. This means that Evista is known to cause birth defects in an unborn baby. Do not take Evista if you are pregnant or if you could become pregnant during treatment. It is not known whether Evista passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Missed Dose

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Possible Side Effects

An infrequent but serious side effect of taking Evista is the development of blood clots in the veins. These blood clots can stop blood flow and cause serious medical problems, disability or death. Call your doctor right away if you have or have had any of the following signs of blood clots in the legs, lungs or eyes: leg pain or a feeling of warmth in the calves, swelling of the legs, hands or feet, sudden chest pain, shortness of breath or coughing up blood, sudden change in your vision, such as loss of vision or blurred vision. Most of the side effects of Evista are mild and usually do not cause women to stop taking Evista. The most common side effects of Evista are hot flashes and leg cramps. Hot flashes are more common during the first 6 months after starting treatment. If you have any problems or questions that concern you while taking Evista, ask your doctor or pharmacist for more information.

Storage

Store at controlled room temperature, 20o to 25oC (68o to 77oF); allows excursions between 15o and 30oC (59o and 86oF).

Overdose

Incidents of overdose in humans have not been reported. There is no specific antidote for Evista.

More Information

Before having any surgery, tell your doctor that you are taking Evista. Treatment with Evista may need to be stopped temporarily if you require an extended period of bed rest. Avoid sitting still for long periods of time during travel while taking Evista. Alcohol and cigarette smoking may cause increased bone loss. Discuss with your doctor the use of these products.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Many of us have been jaded by the constant onslaught of “the latest” medical news, much of which seems to contradict what we just heard or read about the week before. But on July 9, millions of us – patients and health care providers alike – paid rapt attention when the federal government’s National Institutes of Health released findings from a major clinical trial, warning of the risks associated with a widely used type of hormone replacement therapy (HRT) that combines two female hormones, estrogen and progestin. It’s estimated that 6 million postmenopausal American women currently take Prempro or similar combined estrogen-progestin drugs to ease menopause symptoms and to improve their health and well-being. Risks Outweigh Benefit, Study Found The study, called the Women’s Health Initiative (WHI), found that the combined drugs caused increases in breast cancer, heart attacks, strokes and blood clots. Although the risk to an individual woman may be small, the number of cases occurring in the population at large can be great, researchers said. And those risks outweigh the drugs' actual benefits – a small decrease in hip fractures and a decrease in cases of colorectal cancer. The study was released four years earlier than expected because of researchers’ concerns. The WHI study is the first-ever long-term randomized controlled clinical trial – considered the gold standard by medical researchers – of hormone replacement therapy. The WHI was established in 1991 by the government to address the most common causes of death, disability and impaired quality of life in postmenopausal women. The Medical College of Wisconsin is one of 40 WHI clinical sites nationwide where study participants are seen and monitored. The Women’s Health Initiative is a 15-year multimillion-dollar endeavor, and one of the largest US prevention studies of its kind. The study was designed to look at the effects not only of HRT, but also diet modification and vitamin and mineral supplements. Some 67,000 women from across the country, ranging in age from 50 to 79, are participating in the WHI clinical trials. In addition to those women, the study is also following the medical history and health habits of an additional 100,000 women to examine the relationship between lifestyle, health and risk factors with specific disease outcomes. Final results are due out in 2006. More than 16,600 US women are participating in the combined estrogen-progestin portion of the trial, among them 438 women who are in the Medical College of Wisconsin group. They were sent letters telling them to discontinue taking those drugs. The WHI is continuing to study the effects of ERT, or estrogen-alone drugs, used by women who have had a hysterectomy. WHI has not stopped that portion of the study. Jane Morley Kotchen, MD, Professor and Director of Epidemiology at MCW, is the principal investigator for MCW’s portion of the study. She admits she was caught by surprise by the early release. "The breast cancer risks for women on the combined estrogen-progestin therapy are similar to risks that have been found in other studies,” she notes, although she says the cardiovascular findings were not anticipated. “A decreased risk of coronary heart disease had been hypothesized for women on active hormone therapy, so the finding of slightly greater risks for women on the active hormone therapy was unexpected. Overall, the health risks for women taking combined estrogen plus progestin therapy were found to outweigh the benefits. The trial was stopped because the risk-benefit balance, as indicated by a global indicator of overall risk, was unfavorable and the breast cancer risks crossed the predetermined safety boundaries." The WHI’s Data and Safety Monitoring Board – an independent advisory committee charged with reviewing results and ensuring participant safety – set the limits of acceptable risk for breast cancer at an unusually low level of cases per thousand. When that level was reached, the trial was stopped and results were released early. Another Medical College faculty member who served as a WHI investigator agreed that the early release of the findings was surprising. For Vanessa Barnabei, MD, PhD, the medical risks and benefits that caused such a national media furor when the WHI released its combined estrogen-progestin study results had been indicated by earlier patient studies, although earlier studies were regarded as “observational,” and had not met the strict standards of the WHI. Dr. Barnabei is an Associate Professor of Obstetrics and Gynecology at MCW and Director of MCW Physicians’ Division of General Obstetrics and Gynecology. "Early harm from heart disease and stroke were suggested several years ago, and women in the study were informed about it at that time,” Dr. Barnabei says. “And the breast cancer risks have been suspected. The numbers and magnitude of risk are no different today than they were then. Risk ‘Relatively Small’ for Individual Women In a news release from the NIH on July 9, Jacques Rossouw, MD, acting director of the WHI, summarized the risk findings: "The WHI results tell us that during one year, among 10,000 postmenopausal women with a uterus [as opposed to those who have had their uterus removed] who are taking estrogen plus progestin, eight more will have invasive breast cancer, seven more will have a heart attack, eight more will have a stroke, and 18 more will have blood clots, including eight with blood clots in the lungs, than will a similar group of 10,000 women not taking these hormones. This is a relatively small annual increase in risk for an individual woman,” he said. Dr. Barnabei said that she found it interesting that the WHI has continued with the estrogen-only portion of the study. She says scientists have known that progestin can act to influence breast growth and development while reducing the risk of uterine cancer. And an article in the January 26, 2000, Journal of the American Medical Association reported that researchers at the National Cancer Institute had found that women who are current or recent users of combined estrogen and progestin had a higher relative risk of breast cancer than women who only take estrogen. What Patients Should Know Dr. Rossouw, the acting WHI director, offered this advice: “Women with a uterus who are currently taking estrogen plus progestin should have a serious talk with their doctors to see if they should continue it. If they are taking this hormone combination for short-term relief of symptoms, it may be reasonable to continue, since the benefits are likely to outweigh the risks. Longer term use or use for disease prevention must be re-evaluated, given the multiple adverse effects noted in WHI." Dr. Barnabei says she always cautions patients about the potential for increased breast cancer risks. First, she rules out women who are not candidates for HRT– those with vaginal bleeding of an unknown cause, suspected breast cancer or history of breast cancer, history of endometrial cancer or certain cancers of the uterus, chronic liver disease such as cirrhosis or a history of blood clots. For women who are eligible for HRT, the primary reason for HRT is symptom relief, she says, with less emphasis on using hormone therapy for disease prevention: “I explain the known risks and benefits. And I do remind them that the risk for breast cancer does increase naturally for all women as they age, along with heart disease and osteoporosis." Dr. Barnabei tells her patients who want to stop HRT that they can certainly quit anytime. “First of all, with menopause, we’re not treating a disease,” she says. “Stopping HRT has no major consequences except perhaps a return of menopausal symptoms.”

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