Posts Tagged ‘ fosamax femur ’

Fosamax Femur Fractures in Media Spotlight

June 1st, 2010. By janem

I feel sorry for health officials and researchers whose warnings about adverse drug reactions fall on deaf ears; if only they could employ TV anchor Diane Sawyer to heighten public awareness. Case in point: the link between Fosamax and femur fractures.

Since 2008 researchers have suggested that patients-especially women–using Fosamax may be at risk for increased risk of bone fracture. Although the femur is the strongest and biggest bone in the body, a number of Fosamax patients have fractured their femurs simply from from walking. You can watch Diane Sawyer’s investigation and a follow-up report on ABC News here.

But not even Diane Sawyer and the media can budge the FDA. It says a warning to doctors at this point isn’t justified, but they will “seriously look into it”. That’s good news for Merck.  But if the agency sends a letter to doctors, it would allow them to get data they need to have Merck slap a femur fracture warning on the drug. Merck has likely banked heavily on Fosamax profits, especially given the age of baby boomers…

Back to those researchers. In 2008 Cornell University Medical School researchers showed that Fosamax patients are more than 125 times as likely to suffer non-traumatic femur fractures than patients who have not taken Fosamax. And there have been more studies to back-up Cornell.

At first, Fosamax prevents bone loss but loss over time it may also limit the bone’s natural ability to protect itself from stress. A rheumatologist at National Rehabilitation Hospital in Washington DC said that in up to 60 cases he looked at, most patients had been taking Fosamax or another type of bisphosphonate for more than five years.  Potentially, many women who have taken Fosamax for 5 years or more can be walking around with brittle bones that can fracture at any time.

Here’s the clincher: on its website, Merck, the Fosamax manufacturer, says that “…after you start taking Fosamax, even though you won’t see or feel a difference and that for fosamax to continue to work, you need to keep taking it. From what I could glean, none of Merck’s clinical trials lasted more than four years. So how long does Merck want you to take it for?

For that matter, should any drug be taken longer than indicated in clinical trials? After all, the drug was approved based on most trials from 1-2 years. When it was initially approved, Merck stated that “side effects observed in clinical trials were generally mild. The most commonly reported drug-related side effects in subjects taking Fosamax were abdominal and musculoskeletal.

Recent label changes made Merck add the following: bone, joint, and/or muscle pain, occasionally severe, and rarely incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures. But who reads that? Thanks, Ms. Sawyer.

Tags: femur fracture, Fosamax, fosamax femur
Posted in Drugs/Medical | 17 Comments »