FDA Warnings for Osteoporosis Drugs

FDA Warnings for Osteoporosis Drugs
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Medications commonly used to prevent or treat osteoporosis include bisphosphonates, raloxifene, estrogen/progestin supplements, calcitonin and calcium supplements with vitamin D. Some of these medications have serious side effects or risks that warrant warnings from the U.S. Food and Drug Administration. Other, less severe warnings include cautions against using these medication in certain patient populations, such as those with kidney or liver disease.

Bisphosphonates

Bisphosphonates, the most popular being Fosamax, Boniva, and Actonel, are medications that are indicated to prevent and treat osteoporosis in men and women. Bisphosphonates work by inhibiting the activity of osteoclasts, a specific type of bone cell that dissolves bone to release calcium into the blood. The package labeling for Fosamax and other bisphosphonates includes a warning that these medications can cause gastrointestinal or esophageal irritation. To prevent this, the medication should be taken with a full glass of water, and the patient should remain sitting upright or standing for at least 30 minutes. Following these instructions will ensure the tablet does not become lodged in the esophagus, where the medication could cause severe damage to the tissues.
Osteonecrosis of the jaw, or ONJ, has been noted in patients who take bisphosphonates and who also have active infections of the teeth or jaw bones or who are planning extensive dental work or surgery. These patients should not take bisphosphonates until the jaw bone has healed. Bisphosphonates should not be used in patients who do not have sufficient amounts of calcium in their blood, patients who cannot sit upright or stand for 30 minutes, patients who have difficulty swallowing, or patients who have severe kidney disease.

Raloxifene

Raloxifene, manufactured under the brand name Evista, is an estrogen agonist/antagonist that is indicated for the prevention of osteoporosis in postmenopausal women who have a high risk of breast cancer. This medication works by stimulating estrogen receptors in the bone that will help increase bone density but blocking estrogen receptors in the breast that can stimulate the growth of cancerous cells. Because this medication works similarly to estrogen, it has many of the same risks and warnings as estrogen. The FDA has issued a warning about the risk of venous thromboembolism, or blood clots, in the veins of the arms, legs, abdomen or lungs of people using this medication. Women should not take this medication if they have a history of blood clots or a clotting disorder. There is also increased risk of death due to stroke associated with the use of Evista in women with existing coronary heart disease. Women should not take Evista if they have severe coronary artery disease or arterial blockages. Evista should likewise not be used during pregnancy, by person with hepatic disease, by premenopausal women, by women taking other estrogen supplements or by women with high triglyceride levels in their blood.

Estrogens/Progestins

Estrogen hormones in combination with progesterone are indicated for the prevention of osteoporosis in postmenopausal women. One example of a brand name product is Prempro. Estrogen is not considered first line therapy for preventing bone loss because it increases the risk of blood clots, strokes, heart attacks, breast cancer and dementia. The FDA has issued warnings regarding each of those severe risks. Estrogen supplements may also exacerbate edema, or swelling, in patients who are predisposed to the condition.

Calcitonin

Calcitonin is a synthetic version of a natural thyroid hormone manufactured under the brand name Miacalcin. It acts directly on the bone to prevent the resorption, or destruction, of bone by osteoclasts. Because calcitonin is a synthetic protein, it may stimulate a severe allergic reaction in some individuals. Patients should consider being tested for calcitonin allergy by an allergy specialist before taking a dose of the medication. Patients taking lithium may require a dose adjustment, because calcitonin may increase the urinary clearance of lithium.

References

Article reviewed by Libby Swope Wiersema Last updated on: May 31, 2010

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