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

Merck & Co.’s leading osteoporosis drug Fosamax illustrates the Hollywood paradigm. Its patent protection ran out earlier this year leaving Merck in a struggle to regain its share of the profitable osteoporosis market – a market that it once led, thanks to Fosamax.

As Hollywood producers acquire licensing rights for their blockbuster movies, so has Merck acquired licensing rights to a substance that appears to promote oral bone growth. Called JTT-305, it is a recombinant parathyroid hormone (PTH) that stimulates bone formation cells. Merck purchased the right to develop and commercialize JTT-305 from Japan Tobacco (JT), the world’s third largest manufacturer of tobacco products according to its own website.

In a statement issued by Japan Tobacco, Alan Ezekowitz, a Merck representative, said that “partnering with JT to develop this novel compound complements Merck’s portfolio of musculoskeletal drug candidates … In the future, we believe that use of antiresorptive and osteoanabolic agents together may provide an effective way to reduce the risk of fractures in patients with osteoporosis.”

Ironically, Fosmax is blamed for a high incidence of bone fractures in patients who have taken the drug for years. Faced with a growing number of lawsuits and a plummet in Fosamax sales and profits, Merck must come up with some new blockbusters to replace its old moneymakers, lest it appear to investors that it is losing money.

SOURCE: Osteonecrosis and Fosamax › Merck developing possible Fosamax replacement

Pharmaceutical companies for 25 years have “imitated the basic business model of Hollywood” and have “focused on creating blockbusters,” which they “hope will appeal to masses” and “promote like mad,” according to the Times. Pharmaceutical companies must spend as much as $1 billion to promote new medications in their first two years on the market to make the products into a “mega-brand” with at least $1 billion in annual sales.

“Only now is it becoming clear that this business model couldn’t work forever,” as the strategy “had a flaw that executives have long ignored” — the approach “required extraordinary amounts of promotion at the expense of scientific creativity,” the Times reports. During the next several years, pharmaceutical companies will lose patent protection on a number of popular and profitable medications — such as the osteoporosis treatment Fosamax, manufactured by Merck, the antipsychotic Risperdal, manufactured by Johnson & Johnson, and the cholesterol medication Lipitor, manufactured by Pfizer — and the “industry’s scientists have hit a dry spell” and are “not discovering enough new drugs to replace the aging standbys,” the Times reports.

“It would be wrong to believe that this is the end of the industry’s wealth and power,” but, as some pharmaceutical companies “struggle, patients will bear the brunt,” with the prices of medications likely to “rise even faster,” according to the Times (Petersen, Los Angeles Times, 1/27).

January 28th, 2008 by Petersen with Los Angeles Times

SOURCE: Osteonecrosis and Fosamax › Pharmaceutical industry focus on ‘blockbuster’ medications