Fosamax 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.

Fosamax 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.

Fosamax 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.

Fosamax 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.

Fosamax Storage

Store in a well-closed container at room temperature, 15-30°C (59-86°F).

Fosamax 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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Even as Evista (raloxifene) reduced the risk of invasive breast cancer by 44%, compared with placebo, it had a significantly increased relative risk of thromboembolic events -- including fatal strokes -- according to a study of more than 10,000 postmenopausal women. Evista was associated with a 49% increase in the relative risk of fatal stroke (P=0.05), Elizabeth Barrett-Connor, M.D., of the University of California San Diego and colleagues for the RUTH (Raloxifene Use for The Heart) trial reported in the July 13 issue of the New England Journal of Medicine. Evista was also associated with a significant increase in risks of venous thromoboembolic events (P=0.02), but as expected Evista was associated with a significant decrease in risk of clinical vertebral fractures (P=0.007). The 44% decrease in invasive breast cancer risk (P=0.003) among women taking Evista was driven by a highly significant reduction in estrogen-positive breast cancer (P<0.001). Evista did not reduce the risk of estrogen-negative breast cancers (P=0.40). Women taking Evista also had significantly more hot flushes, leg cramps, and peripheral edema (P<0.001 for all compared with placebo), they wrote. The RUTH investigators randomly assigned 10,101 postmenopausal women (mean age 67.5) with established coronary heart disease or multiple risk factors for heart disease to either 60 mg of Evista daily or placebo. The women were followed for a median of 5.6 years. The primary endpoints were coronary events and invasive breast cancer. In this group of women at high risk for coronary events, "the difference in absolute rates of events that were decreased (i.e., breast cancer and clinical vertebral fractures) was similar to the difference in the absolute rates of events that were increased (i.e., venous thromboembolic events and fatal strokes)," the authors wrote. And that may be the sticking point for many clinicians counseling women, said Steven Nissen, M.D., acting director of cardiology at the Cleveland Clinic. "When a drug increases cardiovascular risk, we have to take that seriously," he said adding that Dr. Barrett-Connor and colleagues did an excellent job of "laying out the risks and benefits very clearly, with no spin." Dr. Nissen, who was an early critic of Vioxx (rofecoxib) because of its increased risk of thromboembolic events, said that results of the RUTH trial are likely to spur debate if Lilly, the maker of Evista, seeks FDA approval for Evista for breast cancer prevention. Currently the drug is approved for treatment and prevention of osteoporosis in postmenopausal women. Earlier this year, results of the STAR (Study of Tamoxifen and Raloxifene) trial indicated that Evista is as effective as tamoxifen for preventing breast cancer in postmenopausal women. Tamoxifen is the only FDA approved drug for prevention of breast cancer. Lilly said in June that it plans to ask the FDA to approve Evista for cancer prevention. Evista and tamoxifen are both selective estrogen receptor modulators, or SERMs. SERMs were originally developed as alternatives to estrogen to treat symptoms of menopause as well as osteoporosis. But unlike estrogen, SERMs do not reduce vasomotor symptoms, although they have demonstrated efficacy in osteoporosis. When the RUTH trial began recruiting women in 1998 it was widely believed that estrogen reduced the risk of coronary events, which led Dr. Barrett-Connor and colleagues to hypothesize that Evista would also be cardio-protective. But in 2002, investigators for the Women's Health Initiative reported that estrogen increased the risk of stroke and thromboembolic events, as well as increasing the risk of breast cancer. The RUTH results "now allow us to say that all modulators of the estrogen receptors potentially increase the risk of cardiovascular events," said Dr. Nissen. John T. Cole, M.D., medical director of hematology and oncology services at the Ochsner Health System in New Orleans, said that the RUTH findings coming on the heels of the STAR trial confirm that Evista has a role in chemoprevention in a select population -- but defining that population may be difficult. Even so-called high risk women only have very small absolute risk for developing breast cancer, he said. "If you look at in terms of telling a woman that she has about a 98.4% chance of [not developing breast cancer], it is difficult to imagine her wanting chemoprevention," he said. Nonetheless, Dr. Cole said that in both the RUTH trial and the STAR trial "as risk increased, so did the potential benefit of chemoprevention." In an NEJM editorial, Marcia L. Stefanick, Ph.D., of the Stanford Prevention Research Center in Stanford, Calif., said the RUTH study "highlights the need to consider the risk of breast cancer as well as other risks and coexisting conditions in determining whether and when [Evista] or another SERM is warranted for an individual woman." "For women represented by the RUTH cohort of women with or at increased risk for CHD, the moderate benefits of raloxifene for breast cancer prophylaxis do not seem to justify the risks" she wrote. "For now," Dr. Stefanick continued, "there is no magic bullet that can reduce the risks of major health problems related to estrogens and aging without introducing other potentially serious health concerns."

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