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Fosamax and Osteonecrosis

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Fosamax is linked to osteonecrosis, or bone death, of the jaw. It begins as minor dental problems and can escalate to permanent jaw damage.

It starts after some seemingly minor jaw trauma, but jaw osteonecrosis can quickly decimate a jawbone. Federal drug regulators and researchers say that Fosamax, a drug that’s supposed to help with bone growth, is linked to this rare dental disease that’s also called Dead Jaw Syndrome.

Since 2004, Fosamax (alendronate), which comes from the bisphosphonate family of drugs, has had strong ties to the disease. After countless studies, the U.S. Food and Drug Administration (FDA) ordered the drug’s manufacturer, Merck, to add an osteonecrosis warning to the drug’s label. Merck officials dragged their feet in adding the warning, taking almost a year. The company still vehemently denies any connection.

Problematic Bisphosphonates

Even before Fosamax was introduced in 1995 as a superior osteoporosis treatment, jaw osteonecrosis has been linked to the bisphosphonate drug family. Those receiving intravenous or oral bisphosphonate drugs for cancer treatment were at the highest risk. The thought is that bisphosphonates interfere with the body’s natural ability to correctly repair bone. Fosamax works by slowing the natural bone breakdown and regeneration process.  Instead of removing old bone and replacing it with new, Fosamax stops that process and only allows for new bone growth. Without being able to get rid of old bone, the resulting effect is brittle bones. Some researchers theorize that bisphosphonates make it easier for some strains of bacteria to attach to bone.

Although this destructive disease can happen in other bones in the body, Fosamax has been specifically linked to jaw osteonecrosis.

Bone Deterioration

Jaw osteonecrosis, which happens more in women, typically starts after dental work that doesn’t heal properly, according to the American Dental Academy. Then a stubborn infection sets in and launches more complications. The surrounding tissue erodes, exposing the underlying teeth and bone. As the infection spreads, teeth fall out, the tissue under the jawbone perforates, the blood flow to the bone is cut off and eventually the bone simply crumbles. Even more alarming is that patient often doesn’t know the disease is happening until sharp edges of bone are exposed. Once the bone is crumbled, it is impossible to fix. Prosthetic devices need to be implanted to have a normally functioning jaw.

The Fosamax Link

The link between Fosamax and Dead Jaw Syndrome came from a 2004 study in the Journal of Oral and Maxillofacial Surgery. The study found that a significant percentage of Fosamax patients were developing the disease. The study found that those taking Fosamax the longest were most at risk because bisphosphonates remain in the bones indefinitely. Based on this, the FDA launched its own review and determined that a warning label needed to be added to Fosamax.

Researchers around the country supported the change. In a letter published in the Annals of Internal Medicine, Dr. Susan Ott of the University of Washington wrote, “Many people believe that these drugs are bone builders, but the evidence shows they are actually bone hardeners.”

At the same time, Merck launched its own study to counter the claims. In its study, the company looked at 17,000 Fosamax patients who had taken the drug as long as a decade and found a link unlikely. Still, the company was forced to include the new warning on its drug packaging. That process took nearly a year.

Fosamax Legal Challenges

After federal drug regulators officially acknowledged the link between Fosamax and osteonecrosis, injured patients nationwide began seeking legal justice in court.  Already, nearly 1,000 patients have sued Merck for the osteonecrosis connection. Those cases have been consolidated in federal and state courts in New York and New Jersey. So far several bellwether trials, or test trials, have taken place. One of those cases resulted in a $1.5 million award for the plaintiff. Although several other cases have found in favor of Merck, attorneys are claiming that Merck bribed one of its expert witnesses with a $150,000 payment to say the drug is safe.