important: for FOSAMAX and other bonerelated meds

Discussion in 'Fibromyalgia Main Forum' started by sunflowergirl, Apr 3, 2006.

  1. sunflowergirl

    sunflowergirl Active Member

    This article was in the L.A. Times Health section this morning. Another thing for us to worry about. I've been taking Fosamax for 2 years and now perhaps I need to reconsider.

    RARE INSTANCES OF JAW DECAY are being linked to medicines used to prevent bone loss.
    By Linda Marsa, Special to The Times
    April 3, 2006

    Sue Piervin never suspected the pills she took to strengthen her bones could severely damage her jaw. Twelve years ago, a routine X-ray revealed her bones were thinning, so her doctor prescribed a drug to help stop the erosion of bone density. Then, in 1999, Piervin developed a painful bone spur in her jaw that had decayed to such an extent that it had to be surgically removed.

    At the time, doctors were puzzled. But when she had a recurrence last year, they had a pretty good idea what was causing the trouble: Fosamax, the medication she was taking to prevent bone loss.

    "I had three oral surgeries to remove all the dead bone," says the 56-year-old Los Angeles resident. "It was not a fun summer."

    Since 2001, more than 2,400 patients taking Fosamax and other bone-building medications like it have reported bone death in their jaws, mostly after a minor trauma such as getting a tooth extracted. Most were taking especially potent, intravenously delivered versions of these drugs, which are known as bisphosphonates.

    An additional 120 people who were taking bisphosphonates in pill form to prevent bone thinning have been stricken with such incapacitating bone, joint or muscle pain that some were bedridden and others required walkers, crutches or wheelchairs.

    The incidence of both these complications is minuscule in comparison with the millions of people taking these medications. More than 36 million prescriptions for oral bisphosphonates, such as Actonel, Fosamax and Boniva, were dispensed in 2005, according to IMS Health, a pharmaceutical information and consulting company. Nearly 3 million cancer patients have been treated with intravenous versions of the medications.

    But because at least 90% of drug side effects aren't reported to the Food and Drug Administration, the real number of people stricken with jaw necrosis and other side effects could be higher.

    "We've uncovered about 1,000 patients [with jaw necrosis] in the past six to nine months alone, so the magnitude of the problem is just starting to be recognized," says Kenneth M. Hargreaves, chair of the endodontics department at the University of Texas Health Science Center in San Antonio.

    With concern growing over the possible side effect, the American Assn. of Endodontists last week released a position statement on the problem. "Until further information is available, it would appear prudent to consider all patients taking bisphosphonates to be at some risk," the group said.

    Unreported cases of the pain syndrome may be "considerable," says Diane K. Wysowski of the FDA's Office of Drug Safety, "because physicians may attribute the pain to osteoporosis."

    The issue is especially worrisome, says Dr. Susan M. Ott, an osteoporosis expert at the University of Washington in Seattle, because the number of women taking bisphosphonates stands to increase now that women are more reluctant to preserve their bones by taking estrogen after menopause.

    In 2002, when a landmark study revealed that hormone replacement therapy carried slight but measurable heart and breast cancer risks, prescriptions for oral bisphosphonates shot up 32%, according to IMS Health.

    Bisphosphonate drugs have been used since 1995 to strengthen bone in women who are losing bone density and for nearly 15 years in men and women who have cancer. The medicines act by altering the dynamics of bone, which is constantly being turned over.

    Cells called osteoclasts break bone down. Others called osteoblasts build it up. Osteoporosis occurs when formation of new bone does not keep pace with bone destruction.


    Debate over risks

    Bisphosphonates thwart the action of the osteoclasts, thickening bones and making them less likely to break. Physicians aren't sure why these drugs sometimes do seemingly the opposite and cause jaw death. But they know that osteoclasts are also involved in prompting osteoblasts to form. Consequently, over time, these medications may actually impede rather than promote the creation of new bone.

    Christopher Loder, a spokesman for Fosamax maker Merck, points out that osteonecrosis of the jaw with Fosamax is "exceedingly rare." "In all of our controlled clinical trials with Fosamax, which involved more than 17,000 patients, including some that were 10 years in duration, we had no reports" of it, he says.

    The risk appears to vary according to the strength of the bisphosphonate being used. Recent studies show that about 80% to 90% of jaw decay occurs in cancer patients who take potent intravenous bisphosphonates (Aredia, Zometa). The drugs replenish bone tissue that is lost when cancer spreads to the bone and can reduce pain and the risk of debilitating fractures.

    The rare side effect, called osteonecrosis of the jaw, causes severe infections, swelling and the loosening of teeth. Patients often require long-term antibiotic therapy or surgery to remove the dying bone tissue.

    "I've taken off several jaws because of this problem," says Dr. Salvatore Ruggiero, an oral surgeon at Long Island Jewish Medical Center in New York who was among the first to observe this phenomenon in 2001. "Because bone death can't be reversed, there's nothing we can do for these patients except ease their pain and prevent it from spreading."

    Patients who have cancer-related bone weakening and pain have few options but to take bisphosphonates. More worrisome for experts are the millions of women such as Piervin who take the weaker bisphosphonate pills to treat osteoporosis, and for many more years than do cancer patients. "Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people," Ruggiero says. "Risks increase the longer you're on the drugs, and it can take years for the complication to manifest itself."

    It's not uncommon for rare side effects to come to light only after a drug has been approved, says Dr. Eric Colman of the FDA's Division of Endocrine and Metabolic Drugs in Silver Spring, Md. Serious adverse reactions that weren't apparent in premarket tests emerge in half of all prescription medications.

    "People need to realize there are unknown side effects with every drug, and these medications are no exception," he says.


    What patients can do

    In the last two years, drug makers have added warnings about bone death to some of the medications' labels and about the pain syndrome to all of them.

    But despite an alert sent to physicians by the FDA in 2004, "it's been a battle getting people educated," Ruggiero says. Dentists and oncologists know about the problem, but gynecologists and family doctors, who write many of the prescriptions for oral bisphosphonates, aren't as informed.

    Patients need to be vigilant. "Women taking these drugs for osteoporosis should tell their doctor if they develop severe pain," says Dr. Theresa Kehoe, an endocrinologist with the FDA's Division of Endocrine and Metabolic Drugs.

    In addition, anyone who uses oral or intravenous bisphosphonates should alert their dentist and oral surgeon if they need an invasive dental procedure. Better yet, says Hargreaves, get dental work done before going on these drugs, although avoiding jaw trauma is no guarantee of protection.

    The drugs greatly reduce risks of incapacitating fractures for older women with osteoporosis. Women who don't have osteoporosis but have other risk factors, such as usage of bone-depleting steroids, previous fractures or a family history of the condition can also benefit, says Dr. Charles H. Chestnut III, who heads osteoporosis research at the University of Washington.

    But they should be considered far more cautiously by younger women who have less bone thinning and are taking oral bisphosphonates simply to prevent further deterioration. These meds become incorporated into the bone's matrix, where they can linger for five years or more. Their effects are cumulative. And women are expected to take them for the rest of their lives.

    "These drugs are still relatively new and problems sometimes take years to show up," says Ott of the University of Washington.

    "We're not quite sure what we're dealing with over the long haul. Side effects like this should make ordinary, healthy women think twice."

    Piervin still takes calcium and Miacalcin, a nasal spray that helps preserve bone density but isn't nearly as potent as the bisphosphonates. She also walks every day and does weight-bearing exercise three times weekly to help her bones stay stronger — even parks her car eight to 10 blocks from work to fit more walking into her schedule.

    She'd take hormones, but she's worried about the risk. She'd exercise more, but she doesn't have the time.

    "I'm off Fosamax," she says, "but I'm in limbo regarding future treatment."

    [This Message was Edited on 04/03/2006]
    [This Message was Edited on 04/03/2006]
    [This Message was Edited on 04/03/2006]
  2. sunflowergirl

    sunflowergirl Active Member

  3. elliespad

    elliespad Member

    This is taken from Dr. Mercolas website, his words,

    Dr. Mercola's Comment:

    Dr. John Lee is the physician who wrote "What Your Doctor May Not Tell You About PRE Menopause" He is very strongly opposed to the use of Fosamax, and I could not agree with him more on this issue. It is interesting that Merck, the manufacturer of Fosamax, funded both of these studies and both appeared in two well respected medical journals the same week.

    Fosamax is in the same chemical class (phosphonate) that is used in the cleaners used to remove soap scum from your bath tub. This is a metabolic poison that actually kills the osteoclasts. These are the cells that remove your bone so your osteoblasts can actually rebuild your bone.

    It is quite clear that if you kill these cells your bone will get denser. What these studies do not show is that four years later the bone actually becomes weaker even though it is more dense.

    This is because bone is a dynamic structure and requires the removal and REPLACEMENT of new bone to stay strong. Fosamax does NOT build ANY new bone. The true solution, as I have reviewed in previous newsletters, is to go on natural progesterone. One can review Dr. Lee's book for more information.

    Progesterone is the only substance that I know of that will actually increase bone strength and density. It does this by serving as a growth promoter for the osteoblasts, or the cells that build bone. Of course, it would be wise to have the other basics in place such as adequate amounts of calcium, zinc, magnesium, vitamin D and copper, in addition to exercise and avoidance of items that will damage bone like soda pop and sugar.

    This is one of the main reasons you will not find studies published on natural progesterone as it is a natural substance which can not be patented and no huge amounts of profit can be realized.

    However, please note that in general I am not a fan of the progesterone creams for reasons previously mentioned.
  4. sunflowergirl

    sunflowergirl Active Member

    I'm passing it on to others who have also taken Fosamax
  5. Cromwell

    Cromwell New Member

  6. jole

    jole Member

    I was on Fosamax for my osteopenia, but couldn't take it because of the terrible muscle pain it caused - as if I didn't have enough. Even people with no muscle problems complain of severe pain when on it. That in itself was all I needed to know.

    Didn't realize all this other stuff, though. Wow, what these companies won't do for a buck, Huh?

    Friends -
  7. sunflowergirl

    sunflowergirl Active Member

    and found lawsuits from this connected with the jaw bone death.....from 2004. The problems is most gynocologists and regular doctors aren't keeping up with the info.

    I took my last pill on Sunday and I'm not going to renew it. I've been reading of other ways to help with bone loss among them taking cod liver oil. There was also quite a lot about taking sea salt.
  8. victoria

    victoria New Member

    USC School of Dentistry News
    Tuesday, April 29, 2008

    Biofilms Behind Jaw Deterioration

    A group of University of Southern California School of Dentistry researchers says it has identified the slimy culprits killing the jawbones of some people taking drugs that treat osteoporosis.

    Microbial biofilms, a mix of bacteria and sticky extracellular material, are causing jaw tissue infections in patients taking bisphosphonate drugs, said Parish Sedghizadeh, lead researcher and assistant clinical professor at the USC School of Dentistry.

    Sold under brand names such as Fosamax, Boniva and Actonel, bisphosphonates are prescribed to millions of patients to combat osteoporosis, a bone-wasting disease that increases the risk of fractures.

    Sedghizadeh said there have been increasing reports of osteonecrosis (bone death) of the jaw in patients who have been taking the drugs for osteoporosis or for treatment from the bone-wasting effects of cancer. He said he decided to investigate further after seeing patients in USC dentistry clinics who had the unusual jaw infection.

    “This is the first study that identifies microbial biofilms in the bone of bisphosphonate patients who have osteonecrosis of the jaw,” Sedghizadeh said.

    Jaw osteonecrosis occurs when bacteria-laden biofilms infect the jaw after the bone is exposed, typically because of a tooth extraction or injury.

    The USC research team includes renowned biofilm expert J. William Costerton, director of the Center for Biofilms at the USC School of Dentistry.

    Pioneered by Costerton, biofilm theory has moved scientists beyond thinking of bacteria as free-floating organisms. Instead, bacteria build biofilm communities, attaching to surfaces and communicating and defending against antimicrobial invaders.

    The team used powerful scanning electron microscopes to study patients’ jawbone samples. The images revealed biofilm bacteria sprawling over pitted tissue.

    The scientists are now trying to determine why bisphosphonate drugs seem to open the door for biofilm-associated infections of the jaw.

    “Now that we’ve know biofilms are behind the infection of the jaw, we are studying ways to effectively treat or prevent the osteonecrosis,” Sedghizadeh said.

    The study was funded by the USC School of Dentistry with the assistance of a USC Zumberge Research and Innovation Award.

    The results of the study are published in the April issue of the Journal of Oral and Maxillofacial Surgery.

    === (disclaimer... sorry I don't remember how I got this link, did a quick search and only found this post about it, so thought I'd repost it... if it's already been posted here, sorry, couldn't remember if it was and couldn't find it)

    I find it fascinating that more and more bacteria are being found making biofilm... this includes e coli in UTIs, the Lyme spirochete, and many others... they're smarter than we think, they can hide out til the course of abx is over and reappear.

  9. kitteejo

    kitteejo Member

    This happened to my neighbor/friend her jaw bones deteriated and now she has to have extensive work done to repair it.

    I stopped over a year ago and will never take it again.

    Great information!

  10. sunflowergirl

    sunflowergirl Active Member

    I go next week to the dentist where I'm having major dental work and I'll talk to him about this. 6 weeks ago I finally had to have a tooth pulled. I went off the fosamax about 4 years ago and the dentist told me not to worry after I had been a year off it.
  11. mbofov

    mbofov Active Member

    First, Sunflowergirl, thanks very much for posting this article. It's extremely important information.

    Here's a post I did last June re osteoporosis and supplements and Fosamax:

    Two of my sisters are on osteoporosis meds: fosamax and actonel. These have been very scary to me for a long time because of the possibility of necrosis of the jaw (jaw bone death), which I have told my sisters about, but they have just been doing what their doctors said, although now they are beginning to have second thoughts.

    Now heart problems are showing up in the literature with these drugs. And to put the icing on the cake, I’ve been reading that fosamax works by preventing resorption (loss of bone). However, bone loss is necessary for the formation of new bone. So fosamax actually inhibits formation of new bone. New bone is stronger than old bone. So people on fosamax may have denser bone, but in the long run it will be weaker and more prone to fracture because it’s more brittle.

    So anyways, these meds have scared me for my sisters’ sake. I talked to my doctor about it this week (the one who is extremely knowledgable about nutrition etc.) and he said they should be taking n-actetyl-cysteine, which helps process calcium into a form which can be used by the body, as well as boron, which when taken in the proper dose, can prevent 50% of calcium loss from the bones (!)

    The recommended doses are three 600 mg. n-acetyl-cysteine capsules a day, in divided doses, and 3 mg. of boron a day.

    Here’s a very interesting and informative article about bone health and bone scans and osteoporosis and osteopenia:

    It kind of turns the conventional wisdom about bone scans and osteoporosis on its head.

  12. pjt

    pjt New Member

    have had an issue with Fosamax and dental work. Have got a problem tooth that should really come out, but dentist is reluctant to do it even though risk of jaw necrosis is apparently very small. Even when you come off this drug, it can stay in the body for years as it can have a half life of up to 10 years. Just another example of the disadvantages of taking a drug.
  13. victoria

    victoria New Member

    please don't forget the strontium...

  14. celeste1226

    celeste1226 New Member

    I too had problems with pain in my muscles and joints. My rhemy told me about fosamax. when I told my gyn he said he had never heard of that happening. my rhemy told me to stay off of it completely to see if my pain went away. as of yet it hasnt but not sure if it FM or due to the fosamax. Ill just have to wait and see.