Drug Uses
Fosamax is indicated for treatment and prevention of osteoporosis in postmenopausal women. For the treatment of osteoporosis, Fosamax increases bone mass and reduces the incidence of fractures, including those of the hip and spine. It is also indicated for the prevention of osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment of glucocorticoid. It is used to treat induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density, treatment of Paget's disease of bone in men and women.
How Taken
Fosamax comes as a tablet to take by mouth. It should be taken once a day in the morning on an empty stomach. Fosamax should be taken with a full glass (6-8 ounces) of plain water. Wait at least 30 minutes after taking Fosamax before you eat, drink, or take other medications. Do not take Fosamax with mineral water, coffee, orange juice, milk, or other dairy products. Do not suck or chew the tablet; swallow the tablet whole. Do not lie down for at least 30 minutes after taking Fosamax. Standing or sitting upright helps you get the full dose and decreases heartburn or the risk of injury to your esophagus.
Warnings/Precautions
Before taking Fosamax, tell your doctor if you have a problem swallowing, such as a narrowing of the esophagus; have esophageal ulcers or an esophageal disease; have a condition that causes low levels of calcium in the body; have kidney disease; have stomach ulcers or other stomach or digestive problems; or are unable to stand or sit upright for at least 30 minutes.
You may not be able to take Fosamax, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Fosamax is in the FDA pregnancy category C. This means that it is not known whether Fosamax will be harmful to an unborn baby. Do not take Fosamax without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is not known whether Fosamax passes into breast milk. Do not take Fosamax without first talking to your doctor if you are breast-feeding a baby.
Missed Dose
If you take Fosamax every day and you miss a dose, skip that dose and take the next regularly scheduled dose the following day. Missing one dose will not affect your treatment. Do not take two tablets at the same time.
If you take a Fosamax once a week and you miss a dose, take the missed dose on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.
Possible Side Effects
Stop taking Fosamax if you experience any of the following serious side effects: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
Seek emergency or talk to your doctor if you have difficulty or pain when swallowing; chest pain; pain or burning under the ribs or in the back; or new or worsening heartburn.
Other, less serious side effects may be more likely to occur. Continue to take Fosamax and talk to your doctor if you experience abdominal discomfort; stomach upset, nausea, vomiting, diarrhea, or constipation; headache; muscle, bone, or joint soreness or aches; eye pain; a rash; or an altered sense of taste.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Storage
Store in a well-closed container at room temperature, 15-30°C (59-86°F).
Overdose
Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral over dosage. If you do think that an overdose has occurred, call an emergency room or poison control center.
More Information
Follow you doctor's recommendations about drinking alcohol and smoking. These activities are related to decreased bone density.
Antacids and other medicines taken by mouth may decrease the effects of Fosamax. Do not take any other medicines within 30 minutes after a dose of Fosamax. Talk to your doctor before taking any other medicines during treatment with Fosamax.
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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