fosamax femure fracture

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 said. “The pain was excruciating.”

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

Fosamax, 1 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 trigger spontaneous fractures.

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

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

“More than the final 18 months we are seeing this much more often,” he stated.

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 females who have brittle bones proper now that possibly are prepared to break, and they’re not conscious of it,” said Heller. “And my heart aches for them.”

Sales of the well-liked drug improved when physicians began prescribing it not only to ladies showing signs of osteoporosis, but also those who were osteopenic, and thus, at risk for the disease. Now some doctors worry that staying on the drug for far more than five years can result in some women’s bones to turn into far more brittle.

Weighing the Risks

This is not the first time that numerous doctors have reported an opposite impact for several folks taking the drug. Fosamax has already been linked to severe musculoskeletal pain, as nicely as to a serious bone-related jaw disease referred to as osteonecrosis.

“In worldwide post-advertising experience with FOSAMAX/FOSAMAX Plus D, rare reports constant with osteonecrosis of the jaw have been received. Numerous of these reports lack enough clinical specifics to make definitive assessments and/or are confounded, particularly considering that a generally accepted definition of ONJ in the common 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 company Merck about the reports of femur fractures. Following 16 months, Merck added patients’ reports of femur fractures to the list of possible side effects reported by patients integrated 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 in no way produced an effort to inform the public or physicians across the country who prescribe bisphosphonates of the possible side effect, mentioned Besser.

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

“Nothing is a lot more crucial 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 is a concern, they have to voice it and at least give everyone a fair opportunity to appear at this cautiously,” stated Dr. Joseph Lane, orthopedic trauma surgeon at the Hospital for Unique Surgery in New York City.

How Much for How Long

Numerous scientific studies suggest an overall benefit from taking the medication for women who are at danger for osteoperosis. In reality, bisphosphonates can aid stop hip and spine fractures, which for several women may lead to death.

“Generally your bone is continuously becoming remade,” mentioned Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Unique Surgery in New York City. “These patients do not remake their bone and they acquire harm, microdamage, the collagen gets altered and we require to rejuvenate the skeleton.”

In 2008, bisphosphonate sales exceeded $three.5 billion according to data from IMS Well being. In 2008, more than 37 million prescriptions were written for the osteoporosis medicines.

Even though some physicians use bone density scans to aid drive their decisions, doctors normally prescribe them to ladies who are at an elevated danger for either osteoporosis or fractures from osteoporosis they currently have. A new tool developed by the Planet Well being Organization can establish the threat of getting fractures and can help doctors decide which girls with osteoporosis really should be treated with medications.

Though bisphosphonates are usually proposed for postmenopausal women, investigation does not indicate how extended women ought to be on the drug. Many physicians now advise a 5-year limit.

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

Extra 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