Dr. Jennifer Schneider was standing on a New York City subway train when the train jolted, and Schneider felt a snap in her right leg. It was her femur bone -- the strongest bone in the body.
"I shifted to the right to keep my balance and felt a big crack. I could feel it in my thigh. There was no question in my mind I'd broken my femur," said Schneider, a semi-retired Tucson internist, whose break was in the top third section of her thigh.
"It's extremely unusual to fracture that part of the femur," she said. "It just doesn't happen like that."
Schneider's femur break occurred in October 2001, but it wasn't until 2005 that she began to suspect the cause of the strange injury: prolonged use of the drug Fosamax, which ironically is prescribed to treat and prevent the bone-thinning disease osteoporosis.
Schneider had been taking the drug since 1995, when she was diagnosed with osteopenia, a condition that many doctors consider a precursor to osteoporosis.
"The drug suppresses bone breakdown and in some people, who knows, it does a job that's too good. It oversuppresses," Schneider said.
Fosamax drugmakers from New Jersey-based Merck say there's no proof of a connection between the drug and femur fractures. But in the interest of patient safety, Merck says it voluntarily modified the Fosamax label in July 2009 to include "low energy femoral shaft and subtrochanteric fractures" in the adverse-reactions section of the label.
"In clinical studies, Fosamax (alendronate sodium) has not been associated with increased fracture risk at any skeletal site. The company currently has several ongoing epidemiological studies to further investigate the issue of subtrochanteric femoral fractures," a company statement says. "The fact that an adverse event has been reported does not reflect a conclusion that the post-marketing event is caused by the product."While women whose bones are thinning may certainly be more susceptible to fractures, the upper third of the femur shouldn't be the one to snap, Schneider says. She's filed a lawsuit against Merck. She has also started an online support group for people who have taken Fosamax or other bisphosphonates and suffered femur fractures. The group now has nearly 60 members."All these women were writing me for advice and solace," said Schneider, who has published two articles in the journal Geriatrics about the connection she sees between femur fractures and bisphosphonate drugs like Fosamax."These drugs can be very beneficial for patients with osteoporosis, if used properly and for a shorter period of time," she said. "The problem is that doctors and patients have looked on them as miracle drugs that can be used forever. That just isn't the case."
In May, Schneider gave a presentation to a U.S. Food and Drug Administration panel about the suspected link. She'd like the federal agency to warn people about the possibility of femur fractures with prolonged use of bisphosphonates.There have been lawsuits over so-called "jaw death" and Fosamax. This year a New York jury awarded a 72-year-old woman $8 million after the woman said she developed osteonecrosis of the jaw by taking Fosamax.Schneider is one of several people who has filed suit over Fosamax and femur fractures."I'm not doing this for the money. I'm doing it because I believe Merck needs to be responsible for the effect of this drug, and that's my motivation for being in this lawsuit, for getting publicity," said Schneider, who has made several presentations to local clinicians about her experience.At the FDA hearing, Schneider was one of 17 attendees who said they had suffered low-impact, atypical femur fractures while taking bisphosphonates sold under the brand names of Fosamax, Boniva, Reclast, Actonel and generics.Schneider said she gave a 30-minute presentation to FDA officials summarizing scientific papers published in medical literature in the past few years supporting a connection between long-term use of bisphosphonates and spontaneous fractures of the femur."We would like to see the warnings include information about length of time patients should stay on the drugs, about the importance of recognizing stress fractures in the femur before they can completely fracture, treatment options for stress fractures and warnings against use of these drugs for osteopenia," Schneider said."Bone density is not bone strength. Imagine the bone like china -- very dense, looks great in an X-ray, but drop it and it smashes."
