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Fosamax, Actonel, Boniva and Other Osteoporosis Drugs
Maryland, Virginia, and Washington, D.C.
Fosamax and similar drugs, known as oral bisphosphonates, have long been associated with a risk of degradation or death of jawbone tissue, a condition known as osteonecrosis of the jaw (ONJ). More recently, it has been associated with severe, possibly incapacitating bone, joint, and muscle pain. Now, it seems that the drug may actually be a cause for one of the most serious injuries it was supposed to prevent: thigh fractures.
If you have been taking Fosamax, Actonel, Boniva, Reclast, or another oral bisphosphonate and have suffered serious side effects, the personal injury lawyers at Chaikin, Sherman, Cammarata, & Siegel, P.C. can help you determine whether you may be eligible to receive compensation for your injuries. Please call or email us today for a free initial consultation.
How Fosamax Works
Like other parts of the body, our bones are constantly being removed and rebuilt. When we are young, more bone is built than removed, causing our bones to grow, and also contributing to the density and strength of our bones, making them hard and resistant to fracture. But as we grow older, the process of removing bone begins to outpace the rebuilding of bone, and our bones grow more porous and brittle. This is known as osteoporosis, and is common among older people, especially women. Osteoporotic bones are more likely to break, even under normal use, and some of these breaks can be life-threatening.
Fosamax, Actonel, Boniva, and other oral bisphosphonates work by inhibiting the cells that remove bone, known as osteoclasts, but not with the cells that build bones, known as osteoblasts. This tips the scale back in favor of bone building, which slows or reverses the progress of osteoporosis, hopefully to reduce a person's likelihood of experiencing a serious bone fracture.
For more information on Fosamax and other bisphonates, see our Questions about Fosamax page.
Why Fosamax Might Pose a Risk
Although it is easy to think of bone removal as bad, bone replacement as good, both parts of the process are essential to healthy bones. If one is suppressed while the other is allowed to run rampant, the result may be bones that are not properly structured, may be vulnerable to injury, may not be able to maintain bone mass, or may not be able to heal properly.
Recent studies have shown that patients treated with oral bisphosphonates like Fosamax for four years or less saw significant gains in bone mineral density, but that after four years the gains leveled off or even began to decrease. In addition, studies have shown that patients taking Fosamax long-term have different bone structure than those who have been taking calcium supplements or no treatment for osteoporosis. Bisphosphonates like Fosamax are actually incorporated into the bone structure, and some studies indicate they may interfere with the integrity of bones at the microstructural level.
Fosamax and Osteonecrosis of the Jaw
Osteonecrosis of the jaw was one of the first serious side effects associated with the use of Fosamax. In this condition, the jawbone begins to die and erode away, leading to disability and disfigurement. Most of the time, osteonecrosis of the jaw is seen in people who have had oral surgery or oral infection. One theory is that because the jawbone is one of the more active sites for bone restructuring, it is more adversely affected by Fosamax than other parts of the skeleton. Another theory is that Fosamax's known effect at suppressing the formation of new blood vessels may lead to a decreased blood supply in the jaw, causing the jaw to die from lack of nutrition.
Fosamax and Severe Bone and Muscle Pain
Many patients experience significant muscle or joint pain after beginning treatment with Fosamax, Actonel, Boniva, or other oral bisphosphonates. The pain was sometimes described as extreme, disabling, or incapacitating. The pain began from one day to 52 months after treatment was initiated. According to the Food and Drug Administration's Health Alert, there is no known cause, and no specific risk factors have been identified, but many people only saw relief after treatment with oral bisphosphonates was discontinued.
Fosamax and Thigh Fractures
The Food and Drug Administration (FDA) has announced it has been investigating a possible link between oral bisphosphonates and atypical thigh bone fractures since 2008. The FDA requested all information from bisphosphonate manufacturers related to thigh bone fractures. After conducting a review of all this information, the FDA concluded it "did not show an increase in [the risk of atypical thigh fracture] in women using [oral bisphosphonates]." The FDA also cited a review of data from two large observational studies in patients with osteoporosis, which showed that only 7% of osteoporosis patients experiencing this type of fracture had used Fosamax, about the same proportion as for typical thigh fractures. In addition, the studies show that the ratio between typical and atypical thigh bone fractures is the same for Fosamax users and non-Fosamax users.
However, the FDA is not ruling out a Fosamax link to atypical thigh bone fractures, and some point to research presented at the March 2010 meeting of the American Academy of Orthopaedic Surgeons as indicating an increased risk associated with the drugs. One study looked at the bone structure of 111 postmenopausal women with osteoporosis, 61 of whom had been taking bisphosphonates for a minimum of four years, 50 of whom were taking calcium and vitamin D. This study showed that after four years of use, the positive effects of bisphosphonates began to reverse.
A second study looked at 21 women who had experienced atypical thigh bone fractures, 12 of whom had used bisphosphonates for an average of 8.5 years. Researchers reported that bone tissue heterogeneity was reduced in women who had used bisphosphonates, suggesting there might be differences in some bone quality parameters.
For more information, see Questions About Fosamax.
If you have been taking oral bisphosphonates like Fosamax, Actonel, or Boniva, and experienced one of the above serious side effects, the medical malpractice lawyers at Chaikin, Sherman, Cammarata & Siegel, P.C. can help you understand your legal options. Please call or email us today for a free initial consultation.
