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

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