Fosamax, a popular osteoporosis medication for which nearly 40 million prescriptions have been written, may be putting some at risk for spontaneous femur fractures. Fosamax is part of a group of drugs called bisphosphonates designed to make bones stronger.
Dr. Robert Bunning, a rheumatologist at National Rehabilitation Hospital in Washington DC, believes it is due to the extended use of Fosamax that may be putting some patients at risk for these fractures. He said that in all of the 50 to 60 reported cases, most patients had been taking Fosamax or another type of bisphosphonate for more than five years.
According to Dr. Bunning, “The drugs are supposed to work by shutting down the cells that re-absorb the bone, the osteoclasts. The ones that make the bone, the osteoblasts, are supposed to keep working. However, in biopsies of patients who have had the fracture, it shows that both are shut down.” It is something he calls “frozen bone”, which is brittle and more susceptible to clean breaks of the bone.
“The drugs clearly were designed to make the bones stronger and I think they do for the first few years. They make them denser,” Bunning said. Bunning believes the drug has been shown to be of benefit to many patients with osteoporosis and safe to use for the first five years. He suggests that if you are on Fosamax or a similar drug and experience thigh pain to contact your doctor immediately.
Merck, the manufacturer of Fosamax, is reported to have said there has been no “causal link” demonstrated between long-term use of Fosamax and fractures. Clinical studies have not shown any increased risk of fracture in any part of the body.
A spokesperson with the Food and Drug Administration, FDA, said the agency “is aware of this issue and are actively investigating it.”
Comments
If you have taken fosamax and sustained a femur fracture you should go to fda.gov and fill out a MEDWATCH FORM. This will help notify the FDA the extent of the problem. We filed the first fosamax/onj case in April 2006. Since that time we have been receiving call from patients that are identical to the ones reported on by ABC NEWS last night. The FDA should require Merck to put a Black Box warning label on the drug and require them to write a letter to physicians notifying them of the problem. The only warning Merck has provided is in the package insert.
The Fosamax (Alendronate) study done for FDA approval failed to show any benefit for the majority of the worried well, which is the osteopenia group defined as T score greater than -2.5. This Osteopenia Group actually had higher fracture rates than placebo. This was published by Cummings in JAMA in 1998.
Bisphosphonate drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous mid-femur fracture, heart rhythm disturbances, and severe bone and joint pain.
The spontaneous mid femur fractures are especially troubling, since these are spontaneous fractures without any trauma. Subtrochanteric fractures are pathological fractures, indicating the underlying bone matrix is abnormal. This anormal weakening and brittleness is directly caused by the bisphosphonate drug.
Bottom Line: These are BAD drugs that actually make the bones weaker not stronger, and they should be banned by the FDA . However, knowing the FDA which is in the pocket of the drug
The Fosamax (Alendronate) study done for FDA approval failed to show any benefit for the majority of the worried well, which is the osteopenia group defined as T score greater than -2.5. This Osteopenia Group actually had higher fracture rates than placebo. This was published by Cummings in JAMA in 1998. Bisphosphonate drugs like Fosamax have severe adverse side effects of jaw necrosis (OJN), spontaneous mid-femur fracture, heart rhythm disturbances, and severe bone and joint pain.
The spontaneous mid femur fractures are especially troubling, since these are spontaneous fractures without any trauma. Subtrochanteric fractures are pathological fractures, indicating the underlying bone matrix is abnormal. This anormal weakening and brittleness is directly caused by the bisphosphonate drug. Bottom Line: These are BAD drugs that actually make the bones weaker not stronger, and they should be banned by the FDA .
How many fractures like this? How many bifosfonates treatments? Statistically non (i repeate non ) significant, almost null! Many other drugs are extremally more dangerous!!! Bevare before talk!
How many fractures like this? How many bifosfonates treatments? Statistically non (i repeate non ) significant, almost null! Many other drugs are extremally more dangerous!!! Bevare before talk!
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