Drug linked to death of jawbone. Fosamax, Zometa, or Aredia

[Guest guest]

C

Wed, 17 May 2006 12:07:37 -0700

[beck-n-stuff] Fw: Drug linked to death of jawbone

 

 

 

I saw this on TV recently. They sort of skimmed over it and didn't

say how serious it was. This is so sad.

 

Reading things like this make me glad that drugs were never an option

for me!

 

 

 

 

Drug linked to death of jawbone

By Rita Rubin, USA TODAY

http://www.usatoday.com/news/health/2005-03-13-jawbone-deaths_x.htm

 

Salvatore Ruggiero was puzzled.

 

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.