Fosamax - Drug linked to death of jawbone.

Over a three-year period, the jaws of dozens of patients who had undergone oral surgery at his hospital had failed to heal properly. Part of the jawbone had died and become exposed.

"We never saw this before in the jaw" except in patients who had received radiation therapy to that part of the face, says Ruggiero, chief of oral and maxillofacial surgery at Long Island Jewish Medical Center. "It just never existed."

Further investigation revealed one common thread: All of the patients had been treated with at least one of a class of drugs called bisphosphonates.

Most were cancer patients who had received the intravenous bisphosphonates Zometa or Aredia or both for excessive calcium in their blood or bone tumors.

But about 10% were osteoporosis patients who had taken an oral bisphosphonate, mainly Fosamax.

In May, Ruggiero co-wrote a report on 63 patients with osteonecrosis — or bone death — of the jaw in the Journal of Oral and Maxillofacial Surgery. Six had taken Fosamax, and a seventh had taken Actonel, another oral bisphosphonate for osteoporosis.

The problem doesn't appear to be as severe with oral bisphosphonates as it is with the IV drugs, Ruggiero notes. Patients who have been receiving IV bisphosphonates should avoid having teeth pulled "at all costs," he says.

Based on his cases, a Food and Drug Administration review posted last week on the agency's Web site suggests that osteonecrosis of the jaw (ONJ) is a risk of all bisphosphonates, not just the IV drugs.

Bisphosphonates remain in bone indefinitely. Ruggiero speculates that their long-term use could upset the delicate balance between cells that put calcium in bone and cells that take calcium away.

The FDA review concluded that all bisphosphonate labels should mention osteonecrosis.

Novartis, maker of Zometa and Aredia, added a precaution about ONJ to their package inserts in August, although the inserts note that cancer patients have other osteonecrosis risk factors, such as their malignancies.

Merck spokesman Tony Plohoros says his company is in the process of adding information about the ONJ cases to the Fosamax label. And Terri Pedone, spokeswoman for Sanofi-Aventis, which markets Actonel with Procter & Gamble, says, "We are currently addressing the FDA's request to update the label" with information about ONJ.

Rugierro says he has now seen a total of 12 or 13 cases of ONJ in patients treated with an oral bisphosphonate. Robert Marx, chairman of the division of oral and maxillofacial surgery at Florida's University of Miami, says he's aware of at least 40 or 50 cases of ONJ nationwide in patients who had taken Fosamax.

That's a infinitely small fraction of the approximately 3 million women in the USA who are taking the drug, although most experts agree that only 1% to 10% of adverse events linked to drugs are reported.

Interestingly, some doctors have prescribed IV bisphosphonates "off label" for osteoporosis. And Roche and GlaxoSmithKline announced in December that they are seeking FDA permission to market an IV form of their oral bisphosphonate, Boniva, for osteoporosis.

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First Fosamax case brought in New Jersey
SVG, L.L.P. files first fosamax case in New Jersey Superior Court against Merck & Co.

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• May 23, 2006 |

(Mineola, New York) Sanders Viener Grossman, L.L.P. files first suit against Merck & Co., Inc. in Superior Court of the State of New Jersey, Atlantic County, on behalf of a retired 77-year old Married Man from Smithtown, New York, who was recently diagnosed with Osteonecrosis of the jaw (ONJ).

Mr. Rhys Wass began taking Fosamax in 1996 and took 70 mg once a week for almost 10 years until this April when he was advised by Long Island Jewish Hospital that a biopsy revealed dead bone in his jaw. His Oral Surgeon advised Mr. Wass that this horrific injury was the result of his taking the controversial drug Fosamax. Until then, Mr. Wass had no idea what was causing him to have severe oral infections which started in January 2006 when he had a tooth removed. Since then, his condition has deteriorated to the point that he can barely speak or eat.

Mr. Wass is exploring all available options but there is no easy remedy for this debilitating condition. It is alleged that Merck, who is still reeling over the Vioxx scandal, knew of the dangers of Fosamax and nevertheless put profits over people (once again) causing harm to thousands of innocent Fosamax users.

According to Attorneys Meryl Sanders Viener and Marc D. Grossman, Fosamax victims were not made aware of the risks associated with getting routine dental procedures despite Merck knowing that these people were more likely to have complications and an increased likelihood of severe jaw injuries. And they should know, having already sued Merck on behalf of hundreds of Vioxx victims in this very same courthouse and being quite familiar with the deceptive tactics and disregard Merck has shown for human life in order to sell their products.

The big question remains: Why didn’t Merck at least notify the dental community of these risks? A recent breaking news story in the Wall Street Journal reported claims that Merck, the manufacturer of Fosamax, sold and heavily marketed the drug as safe, despite knowing about its dangerous side effects. Additionally, the article reported that Merck failed to timely change its label to reflect the risk of its product.

What is Fosamax?
Fosamax (generic name- Alendronate) is a bisphosphonate medication used for bone loss or to heal fractures. Although designed to strengthen bone, it can have the reverse effect and weaken bones instead. Cases of Osteonecrosis primarily involving the jaw have been reported in patients treated with bisphosphonate medication. Osteonecrosis means bone death. Osteonecrosis of the jaw (ONJ) thus involves the loss, or breakdown, of the jaw bone. It can be a serious condition and its symptoms include, but are not limited to:

- pain, swelling, or infection of the gums
- loosening of teeth
- poor healing of the gums
- numbness or the feeling of heaviness in the jaw exposed bone

Until recently, the majority of the reported cases of Osteonecrosis of the jaw were discovered in cancer patients who underwent dental procedures. Other well documented risk factors include concerns for people receiving corticosteroids and those who suffer from conditions such as anemia, coagulopathies, infection and pre-existing oral disease. Although most cases of osteonecrosis of the jaw relate to Fosamax side effects which have occurred after receiving dental work, several cases have been reported to occur without the existence of any prior dental work. More studies will have to be conducted and evaluated to finally uncover all the risks of Fosamax. What occurs with this condition is that aledronates can cause the jaw to fail to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can lead to infection and fracture requiring long-term antibiotic therapy or surgery to remove the dying bone tissue.

Individuals using Fosamax or other bisphosphonates should attempt to steer clear of tooth extractions and other major dental work while on the drug as well as contact your doctor or dentist immediately to discuss other options.