Got Bones? » June 2006

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)
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Posted by laura at 1:39 PM | Comments (0)

June 28, 2006

Regrow Teeth and Bones

A tiny ultrasound machine massages gums and stimulates tooth regrowth after being inserted in the patients mouth.

"Right now, we plan to use it to fix fractured or diseased teeth, as well as asymmetric jawbones, but it may also help hockey players or children who had their tooth knocked out," Jie Chen, an engineering professor and nano-circuit design expert, told AFP. (BREITBART.com)

Posted by laura at 3:12 PM | Comments (0)

Vitamin K For Bone Health

Increased intake of vitamin K, both from diet and supplements, has a significant impact on bone health and “striking” reductions in hip fractions, says a new meta-analysis. (nutraingredients.com)

Posted by laura at 9:45 AM | Comments (0)

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"There is no current effective treatment for ONJ, even after the medication is withdrawn.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)

Posted by laura at 2:40 PM | Comments (0)

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)

Posted by laura at 2:39 PM | Comments (0)

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"
(sierratimes.com)

Posted by laura at 2:26 PM | Comments (0)

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)

Posted by laura at 11:58 AM | Comments (0)

Citrus Juice May Strengthen Your Bones

A glass or two of orange, grapefruit or other citrus juice each day may help prevent osteoporosis-linked bone fracture, a new U.S. study in rats concludes. (forbes.com)

Posted by laura at 11:52 AM | Comments (0)

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)

Posted by laura at 7:46 PM | Comments (0)

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

Posted by laura at 7:10 PM | Comments (4)

June 13, 2006

Stontium Ranelate and Strontium Citrate

Strontium ranelate is new drug for osteoporosis from Servier Laboratories. New trial results show that the drug stops bone loss and encourages the growth of new reduced fractures in women aged 80 and over by a third. (dailymail.co.uk)

Also, here is a great article on strontium.... some opinions on its use and an explanation of the difference between strontium ranelate and strontium citrate. Strontium ranelate is the synthetic form and strontium citrate is the natural form of strontium. (canada.com)

Posted by laura at 11:40 AM | Comments (2)

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.

Posted by laura at 9:45 AM | Comments (2)

Osteoporosis Congress Closes

The largest world medical congress devoted specifically to osteoporosis ended in Toronto today, following five days in which nearly 4,000 participants from 98 countries learned of the latest research in this crippling bone disease and clinical strategies to treat patients more effectively. (medicalnewstoday.com)

Posted by laura at 8:52 AM | Comments (0)

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.

Posted by laura at 8:56 AM | Comments (0)

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)

Posted by laura at 5:04 PM | Comments (1)

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:

Musculoskeletal Pain

"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."

Dental

"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.

Posted by laura at 6:54 PM | Comments (0)


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