Fosamax, a prescription medication that was once praised as a superior bone-strengthening agent, may be linked to thousands of broken bones in patients doing nothing more than daily tasks.
For some, fractures happened while they were walking down the street or while standing on a subway. Random and spontaneous thighbone fractures are more common in women taking Fosamax longer than five years.
Studies show that Fosamax (alendronate), which is in a family of drugs called bisphosphonates, is known to slow the body’s natural bone-repair process, making bones brittle and resulting in breaks.
Fosamax Created a New Market
When Fosamax was released in 1995, it was heavily marketed to women to cure conditions called osteoporosis and osteopenia. While osteoporosis is a serious bone disease that leads to increased bone fractures, osteopenia is a much less serious thinning of the bones.
The drug maker, Merck, was instrumental in millions of men and women starting treatment for osteopenia. Before Fosamax, the disease was not considered serious enough for treatment. Shortly after the drug became popular, more and more complaints about the drug’s side effects surfaced. One of them was random bone fractures.
For most Fosamax users who have suffered broken bones, the fractures are considered low-energy, or stress, fractures. That means they happened after a minor impact. Take, for example, Sandy Potter, of New York. The 59-year-old was jumping rope with some neighborhood children when her left thighbone snapped. She had been taking Fosamax for eight years. Another woman, 62, said her thighbone broke while stepping backward.
Even though they are low-impact accidents, they can be highly painful. The breaks are usually clean near the top or middle of the bone.
Connection between Fosamax and Fractures
By 2008, researchers showed a clear connection between long-term Fosamax use and femur fractures. Some of the patients reported that they suffered unexplained aching in their thighbones for weeks and months before the unexplained breaks.
One study looked at 20 patients who had recent broken bones and 19 had been taking Fosamax for an average of about seven years, The New York Times reported.
“Many of these women will tell you they thought the bone broke before they hit the ground,” Dr. Dean G. Loric told The Times.
Dr. Joseph Lane of the Weill Cornell Medical College in New York, whose study of Fosamax was published in the New England Journal of Medicine, said there are several theories as to how Fosamax causes the bone breaks. Some say the drug causes “frozen bone,” a condition that shuts down the body’s natural process of bone breakdown and regeneration. It makes bones more susceptible to clean fractures.
In March 2010, the FDA started its own investigation into the link between femur fractures and bisphosphonate drugs, including Fosamax. The American Society of Bone and Mineral Research submitted its report to the FDA, underscoring the bisphosphonate risks. The research, which was later published in the “Journal of Bone and Mineral Research,” found that long-term use of Fosamax and other bisphosphonates were linked to “unusual but serious fractures of the thigh bone.”
The study looked at 310 people who had sustained random femur breaks and 94 percent of them had been taking Fosamax, or another bisphosphonate drug, for five years or longer. The study found that a majority of those who sustained the fractures had warning signs that included ongoing thigh or groin pain leading up to the fracture
In October 2010, the FDA ordered Merck to change its drug label to reflect the bone fracture connection. It took Merck a full 16 months to change the label after the FDA made the request in 2008.
Even today, Merck officials vehemently deny any relationship between Fosamax and bone fractures. Company officials continually say that Fosamax, as with other bisphosphonates, have been shown to decrease femur fracture.
Since the FDA’s new warning label, an increasing number of Fosamax bone fracture patients have been stepping forward. Already there is a multidistrict litigation (MDL) in the Southern District of New York and several other court cases in states that include New Jersey.