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

Osteoprosis

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