Debate Continues to Rage over Fosamax Side Effects

Washington, DCFosamax, a drug designed to strengthen bone, appears to actually weaken bones in rare cases. Side effects of the drug include osteonecrosis—also known as Fosamax dead jaw—a debilitating condition that affects the jawbone and leaves sufferers with sometimes horrendous health issues. To that end, Fosamax manufacturer Merck & Co. faces a growing collection of lawsuits representing some 900 cases of Fosamax osteonecrosis of the jaw (Fosamax ONJ).

However, osteonecrosis of the jaw isn't the only adverse reaction to Fosamax.

Sandy Potter, 59, was skipping rope one day with some neighborhood children in Queens, New York, when her femur literally snapped in two. The accident happened 11 years after she was diagnosed with osteoporosis. In an effort to strengthen her bones, Potter had reportedly been taking Fosamax for eight years at the time of the accident.

According to the 3/10/10 issue of Digital Journal, Sue Heller had been taking Fosamax for a decade when she broke both of her femur bones. Dr. Kenneth Egol, Professor of Orthopedic surgery at NYU Langone Medical Center, indicated to ABC News that the medical community is seeing these breaks and fractures more frequently. "We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise," said Dr. Egol. "Very unusual, the femur is one of the strongest bones in the body."

However, last month the US Food and Drug Administration (FDA) said that they have yet to find a link between oral bisphosphonates (Fosamax) and atypical subtrochanteric femur fractures. Reviewed data failed to show a clear link between such fractures, but the FDA is keeping the file open and working closely with the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force and other outside experts to gain a greater insight into the issue, according to a 3/10/10 report by Reuters.

The annual meeting of the American Academy of Orthopedic Surgeons in New Orleans provided another reason not to close the case on the potential impact of long-term bisphosphonate use. At the conference, researchers presented data showing that long-term bisphosphonate therapy weakens the structural integrity (buckling ratio) of the proximal femur, which may be causing the atypical femur fractures.

Concerns over the impact of bisphosphonates on the heart were dispelled two years ago when the FDA stated that the drugs presented no overall risk of heart problems. That conclusion came on the heels of reports published in the New England Journal of Medicine, attributing serious atrial fibrillation to bisphosphonates.

In regards osteonecrosis of the jaw, Fosamax manufacturer Merck & Co. has written: "In worldwide post-marketing experience with FOSAMAX/FOSAMAX Plus D, rare reports consistent with osteonecrosis of the jaw have been received. Many of these reports lack sufficient clinical details to make definitive assessments and/or are confounded, particularly since a generally accepted definition of ONJ in the general population is unknown. Rare cases of ONJ have also been reported in patients who do not have osteoporosis and who have not taken any bisphosphonate medicines."

In January a federal judge in Manhattan refused to dismiss a lawsuit alleging that Fosamax caused jaw damage to a woman who took Fosamax for eight years.

Digital Journal reports that many doctors are now advocating a five-year limit.