Sandy Potter, 59 of Queens, New York, was jumping rope with neighborhood young children when she felt her thigh bone snap.

“I went up in the air and I came straight down to the ground,” Potter stated. “The pain was excruciating.”

Potter, who was diagnosed with osteoporosis at age 48, had been taking the popular osteoporosis drug Fosamax for eight years before her femur literally snapped in two.

Fosamax, one particular in a class of drugs called bisphosphonates, is supposed to make bones stronger. But now there's mounting evidence that for some women, taking Fosamax or its generic alendronate for far more than five years could cause spontaneous fractures.

“We are seeing men and women just walking, walking down the methods, patients who are doing low-power exercise,” mentioned Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Quite unusual, the femur is 1 of the strongest bones in the body.”

Egol mentioned X-rays of some of his patients appear more like an injury endured by a auto accident than an otherwise minimal fall.

“Over the last 18 months we are seeing this a lot more regularly,” he said.

Sue Heller, 60, of Castle Rock, Colo., had been on Fosamax for practically ten years. She broke both of her femur bones.

“I'm certain there are a lot of girls who have brittle bones proper now that perhaps are ready to break, and they're not aware of it,” mentioned Heller. “And my heart aches for them.”

Sales of the well-known drug improved when doctors began prescribing it not only to females showing signs of osteoporosis, but also those who were osteopenic, and therefore, at threat for the illness. Now some physicians worry that staying on the drug for a lot more than five years can lead to some women's bones to become much more brittle.

Weighing the Risks

This is not the very first time that several physicians have reported an opposite impact for several people taking the drug. Fosamax has already been linked to serious musculoskeletal discomfort, as nicely as to a significant bone-related jaw illness called osteonecrosis.

“In worldwide post-marketing encounter with FOSAMAX/FOSAMAX Plus D, rare reports constant with osteonecrosis of the jaw have been received. Many of these reports lack enough clinical particulars to make definitive assessments and/or are confounded, especially given that a generally accepted definition of ONJ in the common population is unknown,” responded Merck in a written response to the suggested link. “Rare situations of ONJ have also been reported in patients who do not have osteoporosis and who have not taken any bisphosphonate medicines.”

In 2008, the Food and Drug Administration reached out to the pharmaceutical firm Merck about the reports of femur fractures. Following 16 months, Merck added patients' reports of femur fractures to the list of feasible side effects reported by patients integrated in the drug's package insert.

“It took Merck an whole year to respond,” stated ABC News senior wellness and medical editor, Dr. Richard Besser. “Just six words: 'low energy femoral shaft and subtrochanteric fractures.'”

The FDA has also in no way made an effort to inform the public or physicians across the country who prescribe bisphosphonates of the achievable side impact, said Besser.

Each the FDA and Merck declined ABC News' request for an interview. The FDA said they are seeking into reports of fractures.

“Nothing at all is more essential to Merck than the safety of its medicines,” according to a written statement by Merck to ABC News. A causal relationship between Fosamax and these fractures has not been established, according to Merck.

“The drug organizations have to recognize when there is a dilemma, they have to be up front with the public. If there's a concern, they have to voice it and at least give everyone a fair likelihood to look at this carefully,” mentioned Dr. Joseph Lane, orthopedic trauma surgeon at the Hospital for Special Surgery in New York City.

How A lot for How Lengthy

Many scientific studies recommend an overall benefit from taking the medication for women who are at danger for osteoperosis. In fact, bisphosphonates can support prevent hip and spine fractures, which for several girls may lead to death.

“Normally your bone is continuously being remade,” stated Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Specific Surgery in New York City. “These patients do not remake their bone and they acquire damage, microdamage, the collagen gets altered and we need to have to rejuvenate the skeleton.”

In 2008, bisphosphonate sales exceeded $three.5 billion according to data from IMS Wellness. In 2008, more than 37 million prescriptions had been written for the osteoporosis medications.

Although some physicians use bone density scans to assist drive their decisions, physicians typically prescribe them to ladies who are at an elevated risk for either osteoporosis or fractures from osteoporosis they already have. A new tool created by the World Health Organization can establish the danger of getting fractures and can support doctors establish which women with osteoporosis ought to be treated with medications.

Though bisphosphonates are typically proposed for postmenopausal females, analysis does not indicate how extended girls really should be on the drug. Several doctors now suggest a five-year limit.

“When they are on it for five, six, seven or eight years, they lost their potential to remodel and regenerate their skeleton,” stated Lane. “[Some women] are extremely vulnerable and they will then create issues of brittle bone.”

Further time on the medication depends on doctors' orders, stated Besser.

If you have taken Fosamax you should find out whether you are at risk of suffering a fosamax femur fracture