fosamax femur fracture lawsuit

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

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

Potter, who was diagnosed with osteoporosis at age 48, had been taking the well-known osteoporosis drug Fosamax for eight years ahead of her femur literally snapped in two.

Fosamax, one in a class of drugs named bisphosphonates, is supposed to make bones stronger. But now there is mounting evidence that for some females, taking Fosamax or its generic alendronate for much more than 5 years could cause spontaneous fractures.

“We are seeing individuals just walking, walking down the methods, patients who are performing low-power physical exercise,” stated Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Very unusual, the femur is a single of the strongest bones in the body.”

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

“Over the final 18 months we are seeing this much more often,” he said.

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

“I’m certain there are a lot of ladies who have brittle bones correct now that possibly are prepared to break, and they’re not aware of it,” mentioned Heller. “And my heart aches for them.”

Sales of the popular drug elevated when doctors began prescribing it not only to women showing signs of osteoporosis, but also those who had been osteopenic, and thus, at risk for the disease. Now some doctors be concerned that staying on the drug for a lot more than 5 years can trigger some women’s bones to grow to be a lot more brittle.

Weighing the Dangers

This is not the first time that many physicians have reported an opposite effect for a lot of folks taking the drug. Fosamax has already been linked to serious musculoskeletal discomfort, as well as to a critical bone-associated jaw disease known as osteonecrosis.

“In globally post-marketing knowledge with FOSAMAX/FOSAMAX Plus D, rare reports constant with osteonecrosis of the jaw have been received. Many of these reports lack adequate clinical particulars to make definitive assessments and/or are confounded, particularly given that a generally accepted definition of ONJ in the common population is unknown,” responded Merck in a written response to the recommended link. “Rare instances 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. After 16 months, Merck added patients’ reports of femur fractures to the list of doable side effects reported by patients included in the drug’s package insert.

“It took Merck an entire year to respond,” mentioned ABC News senior health and medical editor, Dr. Richard Besser. “Just six words: ‘low power femoral shaft and subtrochanteric fractures.'”

The FDA has also by no means produced an effort to inform the public or physicians across the country who prescribe bisphosphonates of the doable side effect, stated Besser.

Both the FDA and Merck declined ABC News’ request for an interview. The FDA stated they are seeking into reports of fractures.

“Nothing at all is much 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 difficulty, they have to be up front with the public. If there is a concern, they have to voice it and at least give everyone a fair chance to look at this cautiously,” said Dr. Joseph Lane, orthopedic trauma surgeon at the Hospital for Unique Surgery in New York City.

How Considerably for How Extended

Many scientific studies recommend an overall benefit from taking the medication for girls who are at risk for osteoperosis. In reality, bisphosphonates can assist prevent hip and spine fractures, which for a lot of women may possibly lead to death.

“Typically your bone is constantly being remade,” stated Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Special 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 rejuvenate the skeleton.”

In 2008, bisphosphonate sales exceeded $3.five billion according to information from IMS Well being. In 2008, more than 37 million prescriptions had been written for the osteoporosis medications.

Even though some physicians use bone density scans to assist drive their choices, doctors typically prescribe them to women who are at an elevated risk for either osteoporosis or fractures from osteoporosis they currently have. A new tool developed by the Planet Well being Organization can decide the threat of getting fractures and can support doctors figure out which females with osteoporosis must be treated with medicines.

Even though bisphosphonates are generally proposed for postmenopausal girls, analysis does not indicate how lengthy girls 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 capability to remodel and regenerate their skeleton,” said Lane. “[Some ladies] are extremely vulnerable and they will then create issues of brittle bone.”

Additional 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