FDA Reviews Fosamax Amidst Femur Fractures and “Jaw Death”
Posted By The Carlson Law Firm || 8-Sep-2011
The Food and Drug Administration Advisory Panel plans to meet tomorrow in order to review the safety of bisphosphonates, like Fosamax, Boniva and Actonel, they said. While the safety of bisphosphonates has long been considered, as complaints and complications of consumers mount, the FDA panel will discuss whether the drug is safe for consumers over long term periods.
Fosamax was initially approved by the FDA for the treatment of postmenopausal osteoporosis in 1995, though it is now prescribed for a multitude of bone related conditions. Femur fractures, and “Jaw Death,” or osteonecrosis of the jaw, are just some of the more dangerous side effects patients taking the drug have experienced. The FDA will discuss whether more severe warning labels should be used by bisphosphonates or whether the drug should be pulled from the market completely.
Emerging evidence suggests the risks associated with the use of Fosamax, and its generic versions, trump the suggested benefits of the drug, according to medical professor and bone specialist at the University of Washington, Dr. Susan Ott.
“In my opnion, after five years, in most cases, it ought to be stopped,” Dr. Ott notes.
Although bone health is a concern on the minds of many women, as exhibited by the countless osteoporosis drugs, medications and research hitting the market recently, the side effects of some medications intended to treat can actually affect bone strength.
“What’s being found is that some of these compounds, such as Fosamax, may increase the density of the bone but not necessarily the strength,” San Antonio Dr. Sam Miller, said, questioning the bone vulnerability accompanying a Fosamax regimen.
An additional consideration on the table for FDA discussion is the possible requirement for consumers using bisphosphonates, like Fosamax, to take regular breaks from prescriptions in an attempt to curb side effects.
While new information, research and prescription tactics are imperative, thousands of women continue to be affected by previous consumption of the drugs that have resulted in serious injury.
If you or someone you know has experienced pain and injury as a result of bisphosphonates, Fosamax, Boniva and Actonel, call our defective drug attorneys in Austin, San Antonio, Killeen and statewide Texas, contact us online or visit one of our 11 law firms in Texas.