Bisphosphonates, also called diphosphonates, are a class of drugs that prevent the loss of bone mass and are usually prescribed for the treatment of osteoporosis in postmenopausal women to reduce the risk of common osteoporotic bone fracture. The new safety warnings will be on all bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast, as well as their generic equivalents.

The warning does not affect bisphosphonate drugs that are only used to treat Paget’s disease or high blood calcium levels due to cancer, such as Didronel, Zometa, Skelid, and their generics.

The new safety label changes include an increased risk of a type of atypical fractures of the thigh known as subtrochanteric and diaphyseal femur fractures. Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These extremely rare fractures account for less than 1 percent of all hip and femur fractures, but are predominately reported in patients taking bisphosphonates.

Bisphosphonates serve an important role in the management of osteoporosis, and the agency says the 5 million or so customers who use the drugs should not stop taking them based on the announcement. Any concerns should be directed to their health care providers. The FDA advised doctors to consider if patients on bisphosphonates for more than five years still need the drugs.

SOURCE: Osteonecrosis and Fosamax › FDA warns of unusual thigh fracture from use of osteoporosis drugs

The ongoing safety review was initiated in June 2008, following published case reports of this specific type of thigh fracture in patients with osteoporosis taking bisphosphonates. The agency says it will continue to study this issue along with a team of outside experts, which includes members of the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force.

Bisphosphonates include Merck’s Fosamax, Roche Holding AG’s Boniva, Novartis AG’s Reclast, and Procter and Gamble Co’s Actonel.

Bisphosphonates have been available for the treatment of osteoporosis for about 10 years, however this isn’t the first time the medication’s safety has fallen under FDA review. Reuters reported that in 2008, the New England Journal of Medicine suggested the drug may increase users’ risk of a serious atrial fibrillation, or abnormal heartbeat. After reviewing the claims, the FDA said data didn’t show an overall risk of heart problems.

Bbisphosphonates, however, have been linked to another serious condition called osteonecrosis of the jaw (ONJ), a painful decaying of the jawbone. Merck faces lawsuits involving nearly 900 cases by patients who say Fosamax caused their ONJ.

SOURCE: Osteonecrosis and Fosamax › FDA review shows no link between bone treatment and thigh fractures

“We’ve been told that the risk of oral bisphosphonates is negligible, but 4 percent is not negligible,” said researcher Parish Sedghizadeh to the Columbus Dispatch. ONJ was previously thought by doctors and dentists alike to be rare – with only 0.7 cases reported per 100,000 Fosamax users. The new study is published in the January issue of the Journal of the American Dental Association.

Fosamax is from a family of drugs known as bisphosphonates, designed to help fight the affects of bone decay from osteoporosis. Fosamax is one of the more prescribed brands to treat the disease in recent years, but it is being blamed by some for the rapid increase in the occurrence of ONJ. ONJ is a condition in which the gums expose underlying areas of decaying or dead bone. Severe cases of ONJ may require surgery.

High doses of bone-strengthening drugs like Fosamax have been used in cancer patients to prevent the spread of the disease to the bones. Up to 10 percent of those patients have been diagnosed with ONJ. But the USC study suggests individuals taking lower doses of the medication to fight or prevent osteoporosis are beginning to fall victim to ONJ at higher numbers than previously thought.

SOURCE: Osteonecrosis and Fosamax › Study suggests higher risk of ONJ with Fosamax than previously reported

Fosamax is in a class of drugs called bisphosphonates (also called diphosphonates) that inhibit osteoclast action and the resorption of bone. It is one of the more popular choices for the treatment of osteoporosis. Natural News warns that Fosamax has been shown to increase the risk of ulcers, especially if taken with anti-inflammatory drugs. The publication also questions whether the medication actually strengthens the bone or makes it weaker.

Fosamax may also carry an even more serious risk. Over the past few years, doctors have reported an increased risk of osteonecrosis of the jaw, or ONJ. ONJ is a severe bone disease that causes a reduced blood supply to the bones of the jaw and results in damage or death to the jaw bone. Severe cases ONJ require the removal of the affected bone. Studies suggest the recent dramatic increase in the number of cases of ONJ may be linked to the use of bisphosphonate therapy, such as Fosamax. Diagosis of ONJ often has followed dental extraction where there was lack of healing, and spontaneous exposure of the cortical bone tissue.

Not surprisingly, Natural News suggests a more natural approach to treating osteoporosis. The publication suggests a diet rich in vegetables and herbs will improve bone metabolism far more effectively than diary products. And prevention is always the best course. Natural News suggests a diet high in fruits, vegetables and protein will help women arm themselves in the bone density battle.

SOURCE: Osteonecrosis and Fosamax › Osteoporosis treatment has serious risks; consider natural therapy

The FDA safety review of bisphosphonates, a class of drugs often used to increase bone mass in order to treat osteoporosis, was prompted after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

Bisphosphonates are used to increase bone mass and reduce fracture risk in patients with osteoporosis. They also are also used to slow bone turnover in patients with a disorder called Paget’s disease and to treat bone metastases and lower blood calcium in cancer patients. There are currently 8 bisphosphonates approved for use in the US. They are Fosamax, Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.

Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

A second study published in the same issue of the New England Journal of Medicine cast doubt on another bisphosphonate, Reclast. In a study of 7,736 postmenopausal women with bone-thinning osteoporosis, the risk of a serious case of irregular heart rhythm was more than double that in the other patients.

In announcing the bisphosphonate safety review, the FDA said that it was “unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.” The agency will be seeking additional data on the possible atrial fibrillation risks associated with these drugs, and it expects the safety review of bisphosphonates to take about 12 months.

This is not the first time that the safety of Fosamax has been questioned. The drug has been linked to Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.

October 2nd, 2007

SOURCE: Osteonecrosis and Fosamax › Osteoporosis drugs to undergo FDA safety review