Consumer Reports Health Blog: Should you still take Fosamax or ...

But when you consider that many doctors prescribe bisphosphonates not just for people with outright osteoporosis but also for those with osteopenia, or "pre-osteoporosis," those concerns take on an added urgency. The problem is that it's not as clear that the drugs are effective for this less serious, but much more common condition , which affects more than half of all white, premenopausal women in the U.S.

At the end of the day, should you have to make a trade-off between the reduction in certain kinds of bone fractures, like hip or spine fractures, for increased risk in another, like thigh bones, or bone loss in the jaw?

Bottom line: If you are diagnosed with osteopenia, CU’s medical consultants strongly advise that non-drug measures be used to reduce bone loss instead of taking a bisphosphonate drug. Taking supplemental calcium and vitamin D can strengthen bones, as can walking, dancing, and other weight-bearing aerobic activities. Those exercises also build muscle and improve balance, both of which can help prevent falls that cause fractures. You can further reduce the risk of falls by limiting how much alcohol you drink, avoiding sleeping pills and by fall-proofing your home by keeping extension cords out of the way, installing grab bars in the bathroom and rubber mats in the bathtub or shower, and getting rid of loose rugs.

For those with osteoporosis who already take Fosamax, Boniva, or other bisphosphonates drugs, consider taking a “drug holiday” after five year’s use. The rational: Since the drugs remain active in your system for such a long time once you stop using it, taking any more of it may be unnecessary, unless your doctor determines that your bone loss has become rampant.

Alan Cassels, guest blogger

Bisphosphonate drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous mid-femur fracture, heart rhythm disturbances, and severe bone and joint pain. The spontaneous mid femur fractures are especially troubling, since these are spontaneous fractures without any trauma. Subtrochanteric fractures are pathological fractures, indicating the underlying bone matrix is abnormal. This abnormal weakening and brittleness is directly caused by the bisphosphonate drug. Bottom Line: These are BAD drugs that actually make the bones weaker not stronger, and they should be banned by the FDA . However, knowing the FDA which is in the pocket of the drug companies, no action will be taken until thousands of women with fractured mid-femurs in wheel chairs descend on Washington protesting a BAD DRUG. Perhaps final action will be taken after thousands of cases of mid femur fractures work their way through drug litigation court, our last defense against a BAD DRUG.

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FDA RespondsTo Fosamax Studies

FDA Responds To Research

The Food and Drug Administration posted a response to two reports issued Wednesday that women and men with osteoporosis may actually increase the chance of femur fractures when taking bone-building drugs, such as Fosamax.

After the two studies questioned the long-term use of bisphosphonates, the FDA posted on its Website a notice that it will look into the safety issue.

But the agency added that a 2008 look at the question did not show that the drugs could increase the risk of fracture in the bone below the hip joint.

Bone Quality or Bone Quantity

The two separate recent studies suggest that long-term use of bisphosphonate that slow or stop bone loss occurring during the natural bone remodeling cycle, may alter the properties of bone, making them less structurally sound, more brittle and prone to breaking.

In other words, users may be substituting bone quantity for bone quality after prolonged use.

But in its communication, the FDA says a December 2008 article in Journal of Bone and Mineral Research concluded that the data shows that “patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures.”

In 2008, researchers at the University of Washington found that Fosamax use was linked to a woman’s risk of developing atrial fibrillation, (AF) a chronic irregular heart beat that can cause dizziness and fainting as well as fatigue and in rare cases it can lead to a blood clots and stroke.

Osteoporosis Drugs, Like Fosamax May Increase Risk of Broken Bones ...

Fosamax, one in a class of drugs called bisphosphonates, is supposed to make bones stronger, and for many women, it is safe and effective. But now there’s mounting evidence that, for some women, taking these medications for more than five years could cause spontaneous fractures.

“We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Very unusual, the femur is one of the strongest bones in the body.”

Egol said X-rays of some of his patients look more like injuries from car accidents than from an otherwise-minimal fall.

“Over the last 18 months, we are seeing this more frequently,” he said.

Sue Heller, 60, of Castle Rock, Colo., had been on Fosamax for almost 10 years. She broke both of her femur bones.

“I’m sure there are a lot of women who have brittle bones right now that maybe are ready to break, and they’re not aware of it,” said Heller. “And my heart aches for them.”

Sales of the popular drug increased when doctors began prescribing it, not only to women with osteoporosis, but to others who were osteopenic — with reduced bone density that might lead to the disease. Now some doctors worry that staying on the drug for more than five years can cause some women’s bones to become more brittle.

Weighing the Risks

This is not the first time that many doctors have reported an opposite effect for people taking the drug. Fosamax has already been linked to severe musculoskeletal pain, as well as a serious bone-related jaw disease called osteonecrosis.

Also, the Food and Drug Administration asked the manufacturer, Merck, in 2008 to add information about the report of femur fractures.

After 16 months, Merck added patients’ reports of femur fractures to the list of possible side effects included in the drug’s package insert.

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Fosamax

Fosamax For more information, visit MedicineCoach.com

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Following Tuesday ABC News story reporting a possible link between long-term use of osteoporosis drugs such as Fosamax and spontaneous, atypical thigh bone (femur) fractures, the Food and Drug Administration (FDA) has said it will investigate these claims.

Fosamax (alendronate sodium) is the brand name for the first of a class of drugs known as bisphosphonates approved to treat osteoporosis. Others include Actonel (risedronate sodium), Reclast (zoledronic acid), and Boniva (Ibandronate sodium).

Several Florida primary care doctors interviewed today said because the FDA has not sent out a warning thus far, they were unaware of the potential risk of long term use of any of the bisphosphenates and femur fractures.

At the 2010 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS) this month, preliminary research was presented showing that bisphosphonate drugs such as Fosamax may adversely affect bone quality and increase the risk of atypical fractures of the femur when used for four or more years.

Paget's Disease - Drug Pipeline Analysis and Market Forecasts to 2016

Http://www.global-market-research-data.com/Report.aspx?ID=Pagets-disease-Drug-Pipeline-Analysis-and-Market-Forecasts-to-2016

GlobalData found that that the presently available treatment options are moderately successful in meeting patient requirements. Although the drugs that are currently prescribed are primarily used to alleviate symptoms rather than provide a permanent cure to patients, they have been used in patients with Paget’s disease and have yielded beneficial therapeutic outcomes. However, the unmet need in terms of safety and efficacy in this market is low since bisphosphonates are known to cause no major adverse events in patients if the dosing schedule is appropriately adhered to. The clinical unmet need is therefore likely to remain unaltered over the next few years. There is also a possibility that the unmet need may increase as no new drugs are expected to enter the market in the next few years. Reports suggest that the patients are likely to elicit a weaker pharmacological response to drugs upon prolonged exposure. Hence, higher doses, or drugs with more bioavailability will be required to elicit a response in certain groups of patients. Since no new drugs are currently available in the therapeutic pipeline an increase in the clinical unmet need may also be expected.