Drug linked to death of jawbone

[Guest guest]

Oh dear, thousands and thousands of women are taking this drug. That is

just what they need. Who will not need a tooth pulled at some time or

other. I am so glad I do not take this medicine.

Lynda

At 10:38 PM 9/27/2005, you wrote:

>Drug linked to death of jawbone

>

>By Rita Rubin, USA TODAY

>

>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. 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 GlaxoKline announced in December that

>they are seeking FDA permission to market an IV form

>of their oral bisphosphonate, Boniva, for

>osteoporosis.

>

>

>Drug linked to death of jawbone

>By Rita Rubin, USA TODAY

>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. 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 GlaxoKline announced in December that

>they are seeking FDA permission to market an IV form

>of their oral bisphosphonate, Boniva, for

>osteoporosis.

>

>

>

>Opinions expressed are NOT meant to take the place of advice given by

>licensed health care professionals. Consult your physician or licensed

>health care professional before commencing any medical treatment.

>

> " Do not let either the medical authorities or the politicians mislead you.

>Find out what the facts are, and make your own decisions about how to live

>a happy life and how to work for a better world. " - Linus ing,

>two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

>

>

[Guest guest]

Yikes!

> Drug linked to death of jawbone

>

> By Rita Rubin, USA TODAY

>

> 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. 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 GlaxoKline announced in December that

> they are seeking FDA permission to market an IV form

> of their oral bisphosphonate, Boniva, for

> osteoporosis.

>

>

> Drug linked to death of jawbone

> By Rita Rubin, USA TODAY

> 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. 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 GlaxoKline announced in December that

> they are seeking FDA permission to market an IV form

> of their oral bisphosphonate, Boniva, for

> osteoporosis.

[Guest guest]

Thank you, Rogene! That is truly scary stuff! I’m glad I couldn't tolerate either Actonel or Fosamax!

Kenda

Drug linked to death of jawbone

By Rita Rubin, USA TODAY

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. 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 GlaxoKline announced in December that

they are seeking FDA permission to market an IV form

of their oral bisphosphonate, Boniva, for

osteoporosis.

Drug linked to death of jawbone

By Rita Rubin, USA TODAY

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. 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 GlaxoKline announced in December that

they are seeking FDA permission to market an IV form

of their oral bisphosphonate, Boniva, for

osteoporosis.

Opinions expressed are NOT meant to take the place of advice given by licensed health care professionals. Consult your physician or licensed health care professional before commencing any medical treatment.

" Do not let either the medical authorities or the politicians mislead you. Find out what the facts are, and make your own decisions about how to live a happy life and how to work for a better world. " - Linus ing, two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

[Guest guest]

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

Drug linked to death of jawbone

By Rita Rubin, USA TODAY

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. 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 GlaxoKline announced in December that they are seeking FDA permission to market an IV form of their oral bisphosphonate, Boniva, for osteoporosis.

[Guest guest]

Whoa, this is significant news. And it's not good, except that

perhaps awareness of a problem will lead to more doctors treating.

Interesting also, because I know people who've been treated by Dr.

Marx, who's quoted in the article, reportedly with bad results. Also

know people who jumped on the i.v. biophosphonate bandwagon for

treatment of jaw problems, when it was first being experimented

with. Looks like it may have made things worse for them.

Thanks for posting.

penny

>

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

>

> Drug linked to death of jawbone

> By Rita Rubin, USA TODAY

> 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. 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

GlaxoKline announced in December that they are seeking FDA

permission to market an IV form of their oral bisphosphonate,

Boniva, for osteoporosis.

>

[Guest guest]

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

serious it was. This is so sad.

For those who don't know. Boron will reverse/prevent osteoporosis. Do a web

search on the subject. Twin labs has a triple boron product. I think it is

citrate malate and something else. It works better than any osteo drug and has

no side effects. It is also good for meno symptoms.

Blessings

Donna

http://www.excellentthings.com

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. 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 GlaxoKline announced in December that they are

seeking FDA permission to market an IV form of their oral bisphosphonate,

Boniva, for osteoporosis.

[Guest guest]

Boron also - but in a slightly bigger quantity, up to 9 mg per day I would

say - also cures Arthritis and Lupus Erythematosus.

Dirk Chardet

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.

For those who don't know. Boron will reverse/prevent osteoporosis. Do a

web search on the subject. Twin labs has a triple boron product. I think

it is citrate malate and something else. It works better than any osteo

drug and has no side effects. It is also good for meno symptoms.

Blessings

Donna

http://www.excellentthings.com

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. 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 GlaxoKline announced in December that

they are seeking FDA permission to market an IV form of their oral

bisphosphonate, Boniva, for osteoporosis.