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

Fosamax is from a family of drugs known as bisphosphonates, designed to help fight the affects of bone decay from osteoporosis. Approved by the Food and Drug Administration (FDA) in 1995 as an oral medication to prevent bone loss and fractures, Fosamax has become one of the more prescribed brands to treat the disease in recent years.

Recent studies, however, suggest the drug may cause more harm than good. Fosamax has since been linked to a serious jaw problem known as jaw osteonecrosis (ONJ), a condition in which the jawbone tissue dies causing pain, swelling or infection of the gums and jaw, gums that won’t heal, and loose teeth. Severe cases of ONJ may require surgery.

High doses of bone-strengthening drugs like Fosamax have been used intravenously to treat cancer patients to prevent the spread of the disease to the bones. Up to 10 percent of those patients have been diagnosed with ONJ. The condition was once thought to be a risk only for patients using the medication at higher doses. But a May 2005 report showed that 7 of 63 bisphosphonate users who developed ONJ had been using the oral form.

Merck & Co. is no stranger to controversy. In 2004, the drug company pulled its arthritis medication, Vioxx, off the market after it was linked to heart attacks. Merck has since paid $4.85 billion to resolve claims from thousands of patients harmed by Vioxx.

Source: Reuters

SOURCE: Osteonecrosis and Fosamax › Beasley Allen attorney files lawsuit against maker of Fosamax

Between 2002 and 2005, the Australian unit of Merck paid the publisher Elsevier to publish eight magazines under the title Australian Journal of Bone and Joint Medicine. The magazines appeared to be peer-reviewed medical journals but did not disclose any connection to Merck. The incident, brought to light recently during a personal injury lawsuit in Australia over Vioxx, has raised concerns in international medical publishing.

Vioxx, a brand name of the anti-inflammatory drug Rofecoxib used to treat osteoporosis and acute pain, was pulled from the market in 2004 following reports of increased risk of heart attack and stroke associated with long-term, high-dosage use of Rofecoxib.

Fosamax, a bisphosphate designed to increase the amount of bone in patients who suffer from osteoporosis, has also come under fire in recent years after reports of a severe bone disease affecting the jaw called osteonecrosis of the jaw, or ONj. ONj decreases the local blood supply to the jaw bone, causing damage and death to the jaw bone. Several cases of ONj require the removal of the affected bone.

Since the disclosure, both Merck and Elsevier say they have stopped publishing the journals.

Source: Associated Press

SOURCE: Osteonecrosis and Fosamax › Merck paid publisher to print positive stories about Vioxx, Fosamax

Dr. Gillman warned readers that some popular bone density medications such as Boniva and Fosamax may actually do more harm than good. Boniva, he says, has caused musculoskeletal pain “including back pain, joint pain, intense muscle spasms and also headaches, numbness in the hands, chest pain & tightness, increased heart rate and persistent dizziness to name a few,” he writes. Fosamax has the same side effects, plus another very debilitating one, 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 jawbone. The condition can be painful and irreversible. In severe cases of ONJ, removal of the affected bone is required.

The jawbone is in close proximity to skin and to somewhat of a dirty environment in the mouth. Thus, when a person takes Fosamax, which slows or stops the normal turnover of bone, the jawbone becomes more susceptible to decay, Dr. Gillman says.

“In other words, drugs taken to prevent fractures due to osteoporosis actually set the patient up for breaking bones and poor repair,” he says. The best bet, he says – strengthen your bones the old-fashioned way through diet and weight-bearing exercise.

SOURCE: Osteonecrosis and Fosamax › Doctor warns against bone density-building drugs

“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