fosamax femure fracture

Jul 25, 2012 by korymellet84

Sandy Potter, 59 of Queens, New York, was jumping rope with neighborhood 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 prior to 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 girls, taking Fosamax or its generic alendronate for a lot more than five years could result in spontaneous fractures.

“We are seeing men and women just walking, walking down the steps, patients who are carrying out low-energy workout,” mentioned Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Extremely unusual, the femur is one of the strongest bones in the body.”

Egol said X-rays of some of his patients look much more like an injury endured by an automobile accident than an otherwise minimal fall.

“More than the last 18 months we are seeing this a lot more regularly,” he mentioned.

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

“I’m positive there are a lot of females who have brittle bones appropriate now that maybe are prepared to break, and they are not conscious of it,” said Heller. “And my heart aches for them.”

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

Weighing the Risks

This is not the 1st time that numerous doctors have reported an opposite impact for many men and women taking the drug. Fosamax has currently been linked to severe musculoskeletal pain, as nicely as to a severe bone-related jaw illness named osteonecrosis.

“In worldwide post-marketing and advertising expertise with FOSAMAX/FOSAMAX Plus D, rare reports constant with osteonecrosis of the jaw have been received. A lot of of these reports lack enough clinical specifics to make definitive assessments and/or are confounded, especially since an usually accepted definition of ONJ in the general population is unknown,” responded Merck in a written response to the suggested link. “Rare circumstances 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 business 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,” said ABC News senior well being and medical editor, Dr. Richard Besser. “Just six words: ‘low power femoral shaft and subtrochanteric fractures.’”

The FDA has also never ever created an effort to inform the public or physicians across the country who prescribe bisphosphonates of the feasible side impact, said Besser.

Each the FDA and Merck declined ABC News’ request for an interview. The FDA mentioned they are searching into reports of fractures.

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

“The drug firms have to recognize when there is a problem, 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 appear at this meticulously,” mentioned Dr. Joseph Lane, orthopedic trauma surgeon at the Hospital for Specific Surgery in New York City.

How Significantly for How Lengthy

A lot of studies suggest an overall benefit from taking the medication for ladies who are at threat for osteoperosis. In truth, bisphosphonates can support stop hip and spine fractures, which for many ladies might lead to death.

“Generally your bone is continually becoming remade,” said Dr. Joseph Lane, chief of metabolic bone illness at the Hospital for Specific Surgery in New York City. “These patients do not remake their bone and they acquire harm, microdamage, the collagen gets altered and we want 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 were written for the osteoporosis medicines.

While some physicians use bone density scans to support drive their decisions, physicians generally prescribe them to females who are at an improved threat for either osteoporosis or fractures from osteoporosis they already have. A new tool created by the World Wellness Organization can determine the risk of having fractures and can assist physicians establish which women with osteoporosis should be treated with medications.

Though bisphosphonates are typically recommended for postmenopausal women, study does not indicate how extended ladies ought to be on the drug. Numerous physicians now advocate a 5-year limit.

“When they are on it for 5, six, seven or eight years, they lost their potential to remodel and regenerate their skeleton,” stated Lane. “[Some females] are quite vulnerable and they will then develop difficulties of brittle bone.”

Further time on the medication depends on doctors’ orders, mentioned Besser.

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