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Fosamax, Other Bone Drugs Being Reconsidered in Light of Side Effects

Nov 8, 2010 | Parker Waichman LLP

Some doctors are recommending that women take a break from Fosamax and other osteoporosis drugs known as bisphosphonates. The recommendations come amid growing concern that such drugs may do more harm than good.

Bisphosphonates include drugs sold under the names Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast, as well as generic versions. Since the first bisphosphonate came on the market 15 years ago, millions of women have taken them for osteoporosis. 

Just last month, the US Food & Drug Administration (FDA) added warnings to the labels of Fosamax, Actonel and other oral bisphosphonates after studies showed long-term use of the drugs could be linked to a rare type of thigh fracture. The new warnings are ironic, considering that people with osteoporosis take bisphosphonates to prevent broken bones.

The use of Fosamax and other bisphosphonates has also been associated with osteonecrosis of the jaw (ONJ), or dead jaw syndrome. ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the FDA ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ.

According to a report from the Los Angeles Times, some doctors are starting to tell at least some of their patients to go on a “drug holiday” from bisphosphonates like Fosamax.

“To give high doses indefinitely is not what you want to do,” Dr. Ian Reid, an endocrinologist and bone expert at the University of Auckland in New Zealand, told the Times. “After five years, it’s a good time to reassess. If the bones don’t show osteoporosis, we typically stop the drug and monitor bone density. If they still have osteoporosis readings or have had a fracture, we keep them on medications for out to 10 years.”

In some cases, the Times said doctors are switching osteoporosis patients to different classes of drugs, like the parathyroid hormone drug teriparatide (sold under the brand name Forteo), which, unlike the bisphosphonates, which works by actively building bone. A separate class of drugs called RANK ligand inhibitors, such as Prolia, that works by suppressing bone breakdown by inactivating a protein called the RANK ligand, is also an option. Selective estrogen receptor molecules also help preserve bone mass. Some of these drugs, including raloxifene and tamoxifen, are primarily used to treat breast cancer after menopause, the Times said.

Another doctor told the Times that some practitioners are pulling back from prescribing osteoporosis medications for people who have some bone loss but do not meet the diagnostic criteria for osteoporosis.

“It’s ironic that many of these cases of femur factures were in women with mild bone loss who probably should not have been on these drugs,” Dr. Felicia Cosman, clinical director of the National Osteoporosis Foundation said. “We probably used too many bisphosphonates in too many women for too many years. But it’s not that we should stop it in everyone. The therapy has to be individualized.”

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