Fosamax (alendronate) is part of a class of medications known as bisphosphonates, which are used to fight bone loss from conditions such as osteoporosis and Paget’s disease. Medications such as Actonel, Boniva and Reclast are also in the bisphosphonate class. Although these drugs are supposed to help prevent bone injuries, mounting evidence suggests that Fosamax and other bisphosphonates increase the risk of thigh breaks. Research also suggests that these drugs may increase the risk of a disfiguring bone disease known as osteonecrosis of the jaw (ONJ).
Merck’s Fosamax is one of the most well-known bisphosphonate drugs used to treat osteoporosis. A number of lawsuits have been filed against the company alleging, among other things, that they failed to warn about the risk of jaw disease or atypical femur (thigh) fractures. Unlike a classic fracture, an atypical fracture can occur during everyday activities such as walking. Fosamax lawsuits allege that the drug actually weakens the bone, and makes patients more susceptible to these thigh breaks.
See below for a comprehensive timeline that includes the history of bisphosphonate drugs such as Fosamax, dates of label changes, and updates on lawsuits and potential settlements.
Timeline: Bisphosphonates (Fosamax, Actonel, Atelvia Boniva, Skelid, Reclast, Zometa)
Sept. 29, 1995: The U.S. Food and Drug Administration (FDA) approves Merck’s Fosamax (alendronate) as the first bisphosphonate used to treat and prevent osteoporosis, a condition where bone loss occurs over time. Generally, post-menopausal women and men over 70 are at increased risk of developing osteoporosis.
2005: Worldwide Fosamax sales reach nearly $3.2 billion, according to NPR.
Jan. 31, 2005: In response to a study published in the Journal of Oral and Maxillofacial Surgeons, the FDA requests that Merck update its Fosamax label to include the possibility of jawbone tissue disease.
May 3, 2007: The New England Journal of Medicine (NEJM) publishes two studies linking bisphosphonates to an increased risk of atrial fibrillation, or abnormal heart rhythm. Researchers compared women taking oral bisphosphonates to those taking placebo. Reclast and Fosamax exhibited an atrial fibrillation rate of 1.3 and 1.5 percent respectively, compared to 0.5 and 1 percent with their analogous placebos.
Oct. 1, 2007: The FDA addresses the NEJM studies, and announces an ongoing safety review of bisphosphonates’ association with atrial fibrillation. The agency requests clinical trials on behalf alendronate, ibandronate, risedronate and zoledronic acid sponsors, to compare atrial fibrillation rates with a placebo compared to these medications.
Feb. 6, 2008: Merck’s patent on Fosamax expires, and the FDA approves the first generic versions of Fosamax, to be manufactured by Teva Pharmaceuticals.
Jan. 7, 2008: The FDA warns about severe pain in patients taking bisphosphonates, stating that “The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate.”
Nov. 12, 2008: The FDA issues an update of its ongoing safety review concerning bisphosphonates and abnormal heart rhythm, finding “no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation”. However, the agency also acknowledges that there are conflicting findings on this issue.
Mar. 10, 2010: The FDA addresses atypical subtrochanteric femur fractures associated with bisphosphonate use; these types of breaks occur high up in the thighbone, near the hip joint. In response, the agency announces that it will continue ongoing studies to further investigate this link.
Oct. 13, 2010: The FDA issues an updated safety announcement concerning bisphosphonates used to treat osteoporosis and atypical fractures, stating that the warning label will be changed to address this risk. The label change will affect drugs such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast
Jul. 21, 2011: The FDA addresses a possible link between bisphosphonate use and esophageal cancer. One reviewed study found that the risk doubled for patients with more than 10 prescriptions per year, or using the drug for more than three years. However, no label changes are made.
Sept. 1, 2011: The FDA approves a label update for Reclast (zoledronic acid) to include the risk of kidney failure. In modifying the warning label, the agency stated that “Reclast should not be used (is contraindicated) in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.”
Apr. 2, 2012: The Canadian Medical Association Journal publishes a study suggesting an increased risk of inflammatory eye disease, particularly uveitis and scleritis, associated with bisphosphonate use. Researchers compared the rates of these disorders in first-time users to non-users, and found that first-time users exhibited an overall increased risk of 45 percent.
May 9, 2012:
After reviewing recent trials consisting of 2,342 post-menopausal women, the FDA found that findings “showed little benefit of continued bisphosphonate treatment beyond five years.” The agency suggested that drugs may only be helpful in extreme cases, where risk of fractures is high and bone density is low. However, no specific guidelines were issued.
May 21, 2012:
The Archives of Internal Medicine publishes a study linking bisphosphonates to atypical femur fractures; the risk increases with treatment time. They found that 82% of patients with atypical femur fractures were taking bisphosphonates. The authors confirm the FDA’s previous announcement, that there is little evidence of bisphosphonates’ benefits after 3 to 5 years.
Jurors in the U.S. District Court in Manhattan award $285,000 to plaintiff Rhoda Scheinberg, ruling that Merck failed to warn about the risks of using Fosamax. Her lawsuit was the bellwether case for lawsuits alleging that Fosamax causes osteonecrosis of the jaw (ONJ). The case is Scheinberg v. Merck & Co, Inc., U.S. District Court, Southern District of New York, 09-4119.
Merck faces its second round of Fosamax lawsuits in New Jersey over claims that the bone loss drug causes thigh fractures. The first lawsuit to be tried in Atlantic County was filed on behalf of Christina Su, a New Jersey resident who took Fosamax from July 2003 to February 2009, when she suffered a right femur fracture. About six months later, she suffered a left femur fracture that required the insertion of a rod in her leg.
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