Public Citizen Names Two Groups For Whom Fosamax Has No Benefit of Therapy
A Food and Drug Administration (FDA) advisory committee meeting on bisphosphonate safety held in September 2011 was in part prompted by the growing number of patients who have opted to file Fosamax lawsuits against manufacturer Merck & Co. over their alleged bone injuries. The meeting, which ended with a pledge by the FDA to update bisphosphonate warning labels, should help users and their physicians to make more informed decisions about the long term risks and benefits of the drugs.
But also addressed at the meeting was the matter of whether doctors are are indiscriminately prescribing bisphosphonates. According to testimony provided by experts from the consumer advocacy group Public Citizen, bisphosphonates have no therapeutic benefits for two groups of patients: osteopenia sufferers and those who take the drugs for longer than five years.
Bisphosphonates and Osteopenic Patients
Osteopenia is a condition marked by bone mineral density (BMD) that is below normal but not low enough to be considered osteoporosis. According to Public Citizen, bisphosphonates are unnecessarily marketed to the 34 million women in the United States who suffer from osteopenia. As evidence, the group points to the absence of clinical studies showing that bisphosphonates prevent bone fractures in women who do not have osteoporosis. Citing data from the National Osteoporosis Foundation, Public Citizen suggests that bisphosphonates should only be taken by osteopenic patients with a significant 10-year osteoporotic fracture risk.
Long-Term Bisphosphonate Use
Public Citizen additionally contends that patients who take drugs like Fosamax for more than five years do not decrease their susceptibility to fractures. This claim, says Public Citizen, is supported by multiple data sets, including a pooled analysis that led the FDA to conclude that, “These results suggest no significant advantage of continuing drug therapy beyond 5 years.” In fact, the same results that prompted this FDA statement also shows that the risks for osteonecrosis of the jaw (ONJ) and atypical femur fractures increase 3-4 fold in patients taking bisphosponates for longer than five years.
Contact RLG if You’re Considering a Fosamax Lawsuit
Anyone who suffered a femur fracture they believe was caused by Fosamax is urged to contact the Rottenstein Law Group for a complimentary case review. Through a Fosamax lawsuit, it may be possible to receive compensation from Merck & Co., but you risk receiving nothing without experienced representation. For more than 25 years, the lawyers of RLG have been helping injured consumers hold corporations such as Merck responsible for wrongdoing. To talk with an attorney for free, fill out this form. You can also click on this link to read more Fosamax information.
