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December 20, 2006
Dentists Concerned About Jaw Necrosis
Dentists in Indiana are concerned about seeing more cases of jaw necrosis (decaying jaw bone) linked to the use of bisphosphonates. Apparently you don't have to have a dental procedure for it to occur.
Some cases of ONJ have appeared after someone using bisphosphonates has had a tooth pulled or some other dental procedure, but other cases have appeared “spontaneously,” according to a recent article in Dental Economics
“As far as the dental profession is concerned, there is a definite link [between ONJ and bisphosphonates] and there is no question about that,” Foulkes said. “Our controversy is how to deal with it.”
October 26, 2006
Osteoporosis Drug Warning
A Wisconson CBS station has done a piece warning about osteoporosis drugs. It features a woman with multiple myeloma who developed a jaw infection while taking an osteoporosis drug. They don't name specific drugs in the piece.
The video is in the upper right corner of the page.
September 19, 2006
Bisphosphonates and Skeletal Microdamage
Something your doctor probably doesn't mention when prescribing bisphosphonates such as Fosamax and Boniva is the skeletal microdamage that can occur in your bones during treatment. Skeletal microdamage is microcracks in the bone. Because of this, many researchers have wondered about the longterm safety of bisphosphonate therapy.
A new study says that most of the microdamage happens in the first year of treatment.
Researchers found there was no increase in vertebral microcracks after 3 years of alendronate treatment in comparison to the beagles treated for 1 year. These results suggest that microcrack accumulation is greatest during the early course of alendronate treatment. This is an encouraging sign for long-term safety of these drugs.
The study authors are Dr. Matt R. Allen and Dr. David B. Burr from the Indiana University School of Medicine. Both doctors have received financial support from Eli Lilly, Procter & Gamble, Merck, and Amgen. Dr. Burr holds stock in Pfizer and Amgen and has been a consultant for Eli Lilly, Procter & Gamble, and Amgen.
Now let me get this straight: a drug that is supposed to prevent fractures actually causes fractures the first year of treatment, but it's okay because most of the microdamage only happens during the first year of treatment? This same class of drugs that is also associated with rotting of the jaw and severe bone pain? And we're supposed to accept that these drugs are safe from the mouths of researchers who are paid by the drug companies that sell them and who hold stock in some of the companies?
Think of it this way: thousands of postmenopausal women are given bisphosphonates as a preventative measure, even when their bone density tests are normal. That means people with perfectly normal skeletons are now going to have microcracks in their skeletons. It's really unbelievable.
September 17, 2006
Reclast - the Once a Year Bisphosphonate
Reclast, the latest osteoporosis drug that may be coming to market in 2007 will be a once-a-year treatment. Basically, you are given a massive "infusion" in one sitting. These drug companies keep trying to one-up each other. Boniva is trying to one-up Fosamax by putting out a once-a-month pill and now Novartis is going for once-a-year. What's next - once a lifetime? Let's go even further - how about never?
Why doesn't the Washington Post mention that it is a bisphosphonate and will carry the same risks as other bisphosphonates?
Reclast, given as an annual 15-minute infusion, reduced risk of new spine fractures by 70 percent and hip fractures by 40 percent, according to data supplied by the maker, Novartis Pharmaceuticals Corp. The drug, chemically known as zoledronic acid, also reduced the risk of fractures elsewhere, according to a just-completed international study of 7,736 postmenopausal women with osteoporosis.
August 9, 2006
Fosamax and Bisphosphonate Timeline
Many researchers and doctors are calling the jaw problems associated with Fosamax and other bisphosphonates "bis-phossy jaw." This is derived from the 19th century term "phossy jaw." It turns out there's a long relationship between phosphorus and jaw necrosis. Note the "phos" in bisphosphonate. It's there because these drugs are phosphorus-based. Here's a short timeline of phosphorus, bisphosphonates, and osteonecrosis of the jaw. This timeline is a work in progress and additional information will be added.
19th Century: Match factory workers come down with something called "phossy jaw." It is caused by exposure to white phosphorus. Their jaws abscess, causing pain and disfigurement. Foul-smelling pus drains from their jaws and their jaws glow in the dark (due to the phosphorus). The only treatment is removal of the jaw bone. If these steps are not taken, organ failure occurs and then death. The photograph to the left is of a man with phossy jaw.
Sept. 29, 1995: The FDA approves bisphosphonate drug Fosamax (alendronate sodium) for the treatment of post-menopausal osteoporosis and Paget's disease.
2001: Oral surgeon Salvatore Ruggiero notices that an unusual number of his patients have osteonecrosis of the jaw. He does some digging into their medical records and discovers they are all taking a bisphosphonate called Aredia. He phones Aredia's manufacturer, Novartis AG, and asks them if there are other cases of osteonecrosis related to the drug. He also submits reports to MedWatch.
2002: Not having heard back from the FDA after submitting his reports to MedWatch, Ruggiero calls MedWatch to ask whether they have received his information. "How many of these do I have to put on before something gets done?" he asks.
2003: The FDA takes notice as several reports of osteonecrosis from use of bisphosphonate drugs are submitted to their "postmarketing database."
Summer 2003: Oral surgeon Robert Marx, a department chief at the University of Miami's Miller School of Medicine, has 36 cases of osteonecrosis of the jaw that he suspects are linked to Aredia and Zometa. He calls Novartis to let them know he is planning to write a medical alert in the Journal of Oral and Maxillofacial Surgery warning of the problem.
Sept. 2003: Marx's article is published in the Journal of Oral and Maxillofacial Surgery.
Dec. 2003: By this time, Dr. Ruggiero has 54 patients with osteonecrosis of the jaw.
Aug. 25, 2004: The FDA reviews new cases of osteonecrosis associated with pamidronate and zoledronic acid that have been submitted to them. They also review cases of osteonecrosis associated with oral bisphosphonates. Their recommendation is that the labels be changed to warn patients about the risk of osteonecrosis of the jaw.
Sept. 2004: By this time, Novartis has received 500 case reports of jaw problems in patients taking Aredia and Zometa. The company decides to add a "precaution" to the labels of its bisphosponate drugs Aredia and Zometa and sends letters to doctors alerting them to the problem.
July 2005: Almost a year after the FDA recommended they do so, Merck adds a warning to Fosamax. The warning is buried several pages deep in the package insert.
2005: During 2005, 22.4 million prescriptions for Fosamax are given out.
April 2006: Linda Secrest files a class action lawsuit in Florida against Merck for not warning patients about the risk of osteonecrosis of the jaw in patients taking Fosamax. Hundreds of similar lawsuits are expected to be filed.
July 2006: Earnings reports for Merck are released. The company reports that Fosamax earned $821 million for the second quarter of 2006.
July 20, 2006
Sally Field, Boniva, and Media Ethics
Gary Schwitzer, professor of media ethics and health journalism at the University of Minnesota School of Journalism & Mass Communication, has called attention to an article in the Oregonian in which Sally Field was allowed to sing the praises of osteoporosis drug Boniva without any kind of disclosure that Roche Therapeutics is paying her to do so.
[The Oregonian] ran a story that proclaimed that "Actress Sally Field joins the women who are fighting osteoporosis with medicine, supplements and exercise." Not surprisingly, there was an overt plug for a drug: "Field chose to take Boniva, a once-a-month medication from Roche Therapeutics." And the paper let her get away with this: "I feel it's kind of a miracle."
I'm so glad Schwitzer is calling attention to this. Sally Field can't just go around throwing references to Boniva and how it's changed her life without telling people she works for them. I know it's hard to miss the Boniva commercial featuring Sally, but some people may not know she's the spokesperson.
This whole ad campaign leaves a foul taste in my mouth. She writes a "journal" on the Boniva website in which references to Boniva are not-so-gracefully mixed in with talk about her day to day life. Here's a quote from her June entry:
This month, the whole family is taking a trip together to Hawaii ... I’ll be packing for fun, which means plenty of exercise to keep my bones strong. And I won’t have to pack a load of medication since just one Boniva® (ibandronate sodium) Tablet will help protect my bones for the entire month.
Well, isn't that special!
Related Entry: Rally with Sally Field and Boniva
July 13, 2006
Does Fosamax Build the Wrong Kind of Bone?
Perhaps you think lawyers are blowing the Fosamax dangers out of proportion just to make a buck or two. Maybe you think that the risk of osteonecrosis of the jaw is so rare that it isn't something you should worry about. After all, many people on these drugs have no side effects and their bone density scores have risen. Yes, these osteoporosis drugs may increase your bone density scores, but is it just window dressing? Are your bones really stronger or is it just the scores that are stronger?
John Abramson is a family practice physician on the clinical faculty at Harvard Medical School. In his book, Overdosed America, he writes about osteoporosis, Fosamax, and the kind of bone it builds:
The new bone, formed as a result of taking the osteoporosis drugs, is then formed primarily on the outer part of the bone, the cortical bone. This increases the score on the bone density test but does not necessarily contribute proportionately to fracture resistance.
For the full excerpt on osteoporosis and Fosamax as well as more information about Dr. Abramson and his book, visit the link below.
Excerpt from Overdosed America
July 8, 2006
Mastering the Art of Drug Unswallowing
There's a must-read opinion piece by Stephen Strauss on the problem of biased evidence in the pharmaceutical world and how P & G, the makers of osteoporosis drug Actonel, fudged the data on a study of the effectiveness of the drug. I love his idea of the wish to master "the art of drug unswallowing."
Ah, you think as the water flushes the supposedly healing pharmaceutical down your throat, good to know that there must be unbiased evidence that taking it is good for me.
Nice belief. But if you had been at a recent lecture at the University of Toronto you might well have also wished you had mastered the art of drug unswallowing.
July 6, 2006
Bone Drugs for Every Aging Woman in the World?
This passage from an article in yesterday's Monterey County Herald brings up the concern that doctors are prescribing bisphosphonates like Fosamax and Boniva to women who don't really need them, putting them needlessly at risk for jaw problems and other side effects:
... many postmenopausal women taking the pills may not really need them. Low bone density does not automatically progress to osteoporosis, and even when it does, a debilitating fracture is not inevitable.
Crystal Baxter, a former University of Pittsburgh professor of prosthodontics who now practices in Arizona, said she is very leery of doing elective dental implants in patients who have taken oral bisphosphonates.
"The scary thing," she said, "is that these drugs are being marketed to practically every aging woman in the world." (Monterey County Herald)
July 2, 2006
Dr. Peter Gott on Fosamax
Dr. Peter Gott, a well-known doctor, syndicated newspaper columnist and author, is advising his patients not to take Fosamax, Boniva, or Actonel:
" ... they – especially Fosamax – can cause a serious side effect called mandibular necrosis, or decay of the jawbone. Consequently, I have encouraged my patients to stop taking these drugs and have been searching for an appropriate substitute." (spokesmanreview.com)
Update: The above link no longer appears to be working.
June 29, 2006
Pamela Hines Has Osteonecrosis of the Jaw
Pamela Hines is a 52 year old woman who was taking Fosamax and is suing Merck. She was diagnosed with osteonecrosis of the jaw last year after having a tooth extracted.
"For Hines, the aftermath has been devastating. Now unemployed, she receives an intravenous antibiotic - ironically made by Merck - to help clear the infection in her mouth. She also undergoes hyperbaric treatment five days a week." (sltrib.com)
June 24, 2006
Bisphosphonate-Associated Jaw Disease
Here is an article that gives the estimated half life of bisphosphonates, and factors unique to the oral cavity that may be linked to early manifestation of osteonecrosis in the mouth.
"In order to adequately caution our patients, we need to acknowledge that we are dealing with a condition characterized by a long latency period. That means that the pharmacologic effects of the oral bisphosphonates may not be seen for years, so now is the time to educate our patients."
"There is no current effective treatment for ONJ, even after the medication is withdrawn. Jaw reconstructive surgery, surgical debridements, hyperbaric oxygen therapy, reconstruction with plates, reconstruction with bone, antibiotic therapy, and other treatments have not been completely effective at eradicating the progression of necrotic bone." (biz.yahoo.com)
June 21, 2006
Orthodontics and Osteoporosis Drugs
The American Association of Endodontists (AAE) recently issued an official statement on the subject, warning of the risks. AAE President Marc Balson, D.D.S. said, "With this position statement, we hope to ensure the highest quality care and safety for patients taking bisphosphonates.” He went on to say,“Until further information becomes available, the AAE recommends that all patients taking bisphosphonates be considered at some risk for ONJ, recognizing that the magnitude of the risk varies by patient. The AAE also encourages patients taking bisphosphonates to inform their dental care providers and consult with specialists as needed,” he said. (archwired.com)
June 21, 2006
Cases Against Merck Growing
"Over the last 10 years, tens of millions of people have taken Fosamax believing it would prevent bone deterioration. The drug seemed safe enough at first but in recent years it has been linked to a serious disease that causes death to the bone in the jaw called osteonecrosis of the jaw (ONJ). The disease is an extremely serious condition and 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
Partial or complete loss of the jaw bone"
June 19, 2006
Concern Growing Over Bone-Rotting Side Effect
Here is another good news story on bisphosphonates for osteoporosis. Apparently when you take them the concentration in the bones begins to build up by the third year. Robert Marx, an oral surgeon who first alerted people to the problem three years ago, says that's why it's not surprising that there are starting to be more cases of osteonecrosis of the jaw now.
"Although Fosamax has been prescribed since 1995, usage grew dramatically about five years ago, which Marx said would explain why cases linked to that pill are only now being diagnosed. Actonel has been available since 2000, and Boniva was launched last year. Marx said he doesn't expect to see as many cases associated with those pills right now." (newhousenews.com)
June 15, 2006
Consider the Risks Before Using Bisphosphonates
Women need more information to weigh the possible risks of using bone-bolstering drugs, says Dr. Christine Cook, chairman of obstetrics, gynecology and women's studies at the University of Louisville School of Medicine.
She hopes that by fall more information from drug companies about the drugs, called bisphosphonates, will be in the hands of physicians. (courier-journal.com)
June 15, 2006
Rally With Sally Field and Boniva
Sally Field has joined with Boniva to get the word out about osteoporosis. She was diagnosed last year. The campaign is called Rally with Sally for Bone Health.
"Through a website and a toll-free number, the project is asking at-risk women to join Field in a signed pledge to improve their bone health. The pledge involves five steps: taking sufficient calcium and vitamin D, choosing and maintaining an osteoporosis drug regimen, exercising regularly, visiting a physician regularly, and avoiding smoking and excessive alcohol." (medicinenet.com)
I have seen her commercial on TV countless times, so I went to the website to check out the campaign and came away with some serious concerns. There on the homepage is indeed a request for patients to pledge or promise to do the above five things. I find little problem with promising to do 4 of them, but find it very offensive that they would ask patients to PROMISE to take an osteoporosis medication....right next to "click here" to find out more about Boniva. What a great thing for a drug company. Let's get women to promise to take their medication..... and hope they pick Boniva of course. (When you sign up they send you Boniva information.)
Sally Field has chosen to take Boniva. Although I am not a fan of bisphosphonate drugs in light of the recent lawsuits and revelations about jaw necrosis, I think it's great that she is drawing attention to osteoporosis. But teaming up with a drug company and asking people to sign a pledge and promise like little children to take a drug seems to me to be inappropriate and quite scary.
By the way, Roche, the manufacturer of Boniva, lists side effects on the site under Patient Information, but possible jaw necrosis is NOT listed. They just say there may be other possible side effects and you should consult your health care professional.
Related Entry: Sally Field, Boniva, and Media Ethics
June 11, 2006
Dr. Rosenfeld on Fosamax
Dr. Isadore Rosenfeld has a show on Fox News on Sunday mornings called Ask the Doctor. I usually tape it so I can listen later, and on April 23rd, shortly after the Fosamax lawsuits stories were published, someone asked the following question. Here is his answer:
Should people stop taking Fosamax?
“It’s very important to take Fosamax. Don’t let these headlines deter you. However, you should know, if you’re taking Fosamax, and you have a dental problem—you go to the dentist and he has to extract a tooth—that exposes a piece of the jawline which in women who take Fosamax can become infected, and when that bone becomes infected it can rot, and so on, and collapse. So what you need to remember is not to stop Fosamax—continue your Fosamax if your doctor has prescribed it—but if you go to the dentist tell the dentist and he or she may have to give you antibiotics and keep a close eye on the site of the extraction or sometimes they may decide not to do an extraction and maybe do a root canal instead. So it’s something you ought to discuss with your dentist. I’m so concerned because so many of my patients have been calling and saying, ‘Listen, should I stop Fosamax?’ The answer is no.”
So he says don't stop Fosamax, just remember to tell your dentist you're on it so he can be very very careful to not do anything that could cause your jaw to rot. I just find this answer to be incomprehensible. Would Dr. Rosenfeld risk taking Fosamax if he knew there was ANY possibility of his own jaw disentegrating? I can't believe that he would. As all the people on these drugs get older the odds are pretty good they are going to need some dental work that could put them at risk for osteonecrosis. So take this pill and wonder for the rest of your life what might happen if you need some dental work?? Don't let the headlines deter you? Dr. Rosenfeld, I enjoy listening to you, but I just do not understand this reasoning.
As I wrote in a previous post, Stella Poe said if she had been warned of the risks she wouldn't have taken Fosamax. I find it hard to believe that anyone would.
June 9, 2006
Your Right to Sue
This isn't specifically about bones but I thought it was very pertinent considering the recent lawsuits over Fosamax. Looks like in the future you won't be able to sue if you're injured from taking a prescription drug.
"Experts say the new labeling system for prescription drugs about to launch in the United States will not radically improve patient safety or the prescribing process. What's more, the new rules include a clause, slipped in silently after the public-comment period had closed, that will make it almost impossible for patients to sue drug makers over adverse events, said the authors of a perspective piece in the July 8 New England Journal of Medicine." (excite.com)
Apparently several members of the House of Representatives are objecting to this provision and the lack of debate beforehand. Court challenges are probably likely.
June 8, 2006
Stella Poe Wouldn't Have Taken It
Stella Poe is one of dozens of women who took Fosamax and is suing Merck, the maker of Fosamax. She took it for eight years and now has no teeth and no bone in her jaw. "If there was a warning, I wouldn't have taken it. ... I wouldn't have taken it," she said.
"When Poe began taking Fosamax, her attorney says there was no mention of ONJ under the warning label. In 2005, the FDA requested Merck include that in their warning. It has been there ever since, but patients like Poe say they were never told". (MySA.com)
June 7, 2006
Known Risk Factors for Osteonecrosis of the Jaw
As I mentioned in my blog, (Is It Hot in Here?), I have osteoporosis and a doctor a few years ago got very mad at me when I said for the third time I didn't want to take Fosamax. She said, "I have talked to you until I'm blue in the face..." and then walked out. At the time, I just sat on the table in stunned silence. Needless to say, I never went back.
I knew it was something I didn't want to do. My mother had terrible esophagus problems at the same time she was dying from breast cancer. We didn't connect it to the Fosamax then. Obviously there were much worse problems to deal with. She just kept saying there was something wrong when she swallowed. But I do know that the doctors were still telling her to take it while she was in bed, and that can lead to problems. She also was in excrutiating bone pain. Was that from the Fosamax or the cancer? We'll never know.
Now that all of these news stories and lawsuits have surfaced about the side effects of Fosamax and other bisphosponates I am so thankful I never took it. I can't imagine having to wonder if something might happen to my jaw if I ever have to have some kind of oral surgery. The National Osteoporosis Foundation estimates that 8 million women have osteoporosis and 22 million have low bone mass and are at risk of developing the disease. I keep thinking about the women who have taken these drugs and I worry what the future is going to bring. There must still be doctors who are prescribing these drugs without advising of the possible side effects. I think patients have a right to decide for themselves, after receiving all the facts, if they want to take the chance of their jaw disintegrating.
From the Fosamax website: Prescribing information was "For Healthcare Professionals". The site didn't prevent me from accessing the information, but why not just say it's for everyone? Why wouldn't this information be for the patient? Don't we have a right to see ALL the side effects and to be informed? Apparently not.
Here is some of what I found:
"In post marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis (see ADVERSE REACTIONS). However, such reports have been infrequent. This category of drugs includes FOSAMAX (alendronate). Most of the patients were postmenopausal women. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. In placebo-controlled clinical studies of FOSAMAX, the percentages of patients with these symptoms were similar in the FOSAMAX and placebo groups."
"Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing, has been reported in patients taking bisphosphonates. Most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with intravenous bisphosphonates, but some have occurred in patients with postmenopausal osteoporosis. Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), poor oral hygiene, and co-morbid disorders (e.g., pre-existing dental disease, anemia, coagulopathy, infection). Patients who develop osteonecrosis of the jaw (ONJ) while on bisphosphonate therapy should receive care by an oral surgeon. Dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk for ONJ. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment."
I love the "known risk factors for osteonecrosis" part. Seems to me that taking Fosamax should be a known risk factor.
May 24, 2006
Your Jaw Bone in a Bucket
In the past month the osteoporosis drug Fosamax has been in the news due to lawsuits that allege it can cause osteonecrosis of the jaw. Fosamax is a bisphosphonate drug. Other drugs in this class include Boniva and Actonel, among others. Over 30 million women were given prescriptions for Fosamax last year. Since the story first came out I've been researching the subject and am working on a long post on this topic but for now here's a story about one woman who is suing Merck over Fosamax.
Raisor was told her jaw bone was going to end up in a bucket. "They took some out, took some out, kept taking more out," Raisor said.
They tried to save what they could. They used a metal plate for reinforcement.
It didn't work. (wave3.com)