Posted on 04/15/2006 10:37:12 PM PDT by neverdem
Like thousands of women in their 50s, Linda Secrest developed osteoporosis and her doctor prescribed Fosamax, a medication to reverse bone loss.
That was in early 2000, before the Naples woman's life changed forever.
Today Secrest is on a soft-food diet and may have to switch to liquids for a time, according to her Pensacola attorney Timothy O'Brien.
Six or seven months after she started on Fosamax, Secrest underwent a root canal in September 2000. She had no inkling the medication can lead to infection and tissue loss after invasive dental procedures, including having cavities filled.
Secrest fell victim to a painful infection with swelling. The infection refused to heal and led to a jawbone tissue disease, called osteonecrosis of the jaw, referred to as ONJ, where tissue doesn't heal and becomes exposed after a minor trauma, such as invasive dental work.
Secrest and her husband, Frank Secrest, filed a personal injury and product liability lawsuit this past week against Merck & Co., the manufacturer of Fosamax. Class-action status will be pursued for similarly injured victims, O'Brien said. The lawsuit was filed in federal court in Fort Myers.
"We have over 200 clients all over the U.S., but the majority are in Florida," O'Brien, of the national firm Ennis & Ennis, said.
His law firm is among others nationwide working on negligence claims against Merck regarding Fosamax, following a similar course as the 9,000 lawsuits logged against the drug manufacturer for failure to warn of potentially deadly side effects from its painkiller Vioxx.
"Merck's problem is bigger here than with Vioxx," O'Brien said, adding that there is a clear link the jawbone tissue disease and Fosamax. "It is not that (the jaw tissue disease) is so uncommon. It is just that the causes are so few."
A top seller for Merck, bringing in more than $3 billion in sales, Fosamax was first approved by the Food and Drug Administration for osteoporosis in September 1995. The medication belongs to a class of drugs known as bisphosphonates, used for treating bone conditions and as chemotherapy for cancer patients.
During the late 1990s and later, cases were surfacing where cancer patients on bisphosphonates, namely intravenous drugs Aredia and Zometa, had developed jawbone deterioration.
In 2004 after seeing an increase of jawbone necrosis in patients on bisphosphonates, a group of oral surgeons published an article in the Journal of Oral and Maxillofacial Surgery relating their findings involving 63 patient cases. Novartis, the manufacturer of Aredia and Zometa, responded by issuing a warning to doctors in November 2004.
On the other hand, Merck did not take such action, although the company knew or should have known that Fosamax, as part of same class of drugs as the chemotherapy agents, inhibit blood flow and tissue growth, according to the lawsuit. That's despite the FDA recommendation that Merck should amend its labeling for Fosamax to specifically warn of the risk of the jawbone disease.
"As a result, a minor injury or disease can turn into a nonhealing wound," according to the lawsuit. "That in turn can progress to widespread necrosis (bone death) and osteomyelitis (inflammation of bone marrow)."
Merck did not undertake any further clinical studies on Fosamax to examine the risk of jawbone loss, and the pharmaceutical company did not warn the medical community or consumers of the risks, according to the lawsuit.
Merck spokesman Chris Loder issued a prepared statement in response to the lawsuit:
"The cause of osteonecrosis of the jaw (ONJ) is not well understood and is likely to include a number of conditions. In all of our controlled clinical trials, including the 10-year data with Fosamax, we have not had reports of osteonecrosis of the jaw occurring in patients taking Fosamax. Merck has received post-marketing reports described as osteonecrosis of the jaw occurring in patients taking Fosomax. Post-marketing reports do not necessarily indicate causality."
On Jan. 31, 2005, Merck received a request for data from the FDA to update the label for Fosamax to include bisphosphonate class labeling for the jawbone tissue disease, according to the statement.
"Merck submitted a draft to FDA on March 1, 2005," according to the statement. "FDA comments on this draft revised label were received in June 2005 and the new label was made publicly available in July, 2005."
Dr. Salvatore Ruggiero, lead author of the 2004 article that linked the class of drugs to jawbone necrosis, said Merck likely would not have known that Fosamax can lead to jawbone necrosis.
"The problem is the complications with the drugs, especially the oral form, will take many years to manifest, so you won't see it in phase one, phase two or phase three (clinical) trials," Ruggiero, chief of oral and maxillofacial surgery at Long Island Jewish Medical Center, said. "So I'm not surprised they did not know of this complication. When Merck became aware of the problem? I don't know."
The FDA did issue a broad warning covering the entire class of the drugs but he does not recall when that occurred and when Merck acted.
"The timing of it is what the lawyers are going nuts over," he said, adding that his focus was making oncologists, dentists and primary physicians aware of the medical complication.
The predicament now is that no studies are under way to further show the connection, although his clinic is following 155 patients with jawbone necrosis.
"Do we all think it is happening? Absolutely, but we need prospective studies," he said. "The association is very strong."
His theory is that the longer an individual is on this class of medications, the risk of jawbone necrosis increases following invasive dental work.
Dr. James Green, an oral surgeon with the University of Florida's College of Dentistry, said the dental community became aware of the incidence of jawbone death with bisphosphonates five or six years ago.
"My experience runs about three or four years," he said. "I don't know why we are seeing it now, all of a sudden we are seeing these cases now."
At the same time, Fosamax is responsible for many fewer cases of jawbone death than the chemotherapy medications of the same class of drugs.
"Fosamax is a little player, about 4 percent of the cases," Green said, adding that it is confusing why Fosamax is facing the personal injury attention unless Merck did not reveal the risks.
O'Brien, the plaintiff's attorney, said the reason for the focus on Fosamax is that it is prescribed for a noncritical condition, whereas the chemotherapy drugs aim to save a patient's life.
Secrest, the Naples plaintiff, and other defendants will need coninuing medical monitoring that goes beyond normal medical care, according to the lawsuit.
In Secrest's case, her non-healing infection led to teeth having to be removed and an attempt with dental implants which didn't take, O'Brien said. The couple have declined to comment about the lawsuit.
She had 60 treatments in a hyperbaric chamber, which stimulates blood vessel growth for tissue healing, to no avail.
"They were not much help," her attorney said. "She now has exposed jawbone, she has significant bone loss. It's very, very trying on her. If you look at her, you will see a ravaged mouth. It is very trying because there is no fix."
Rate of bacterial infections drops among infants after new vaccine
FReepmail me if you want on or off my health and science ping list.
bump for reference.
The culprit may be Clostridium difficile instead of FOSAMAX. This bacteria infects most people of elderly age. It constricts the blood supply. It causes gum disease. It results in an aberrant release of calcium which causes osteoporosis which gives rise to the need of taking FOSAMAX. It interferes with Rho G protein signaling cascade which is involved in tissue growth. C. difficile causes osteomylitis and destruction of cartilage. It causes nerve damage. C. diff Toxin B binds to glycoconjugates (various forms of sugars) particularly glycoproteins involved in inter-cellular communication. This is combination with its ability to shut down macrophage phagocytosis results in a collapsing immune system. C. difficile is what makes it easy to kill elderly people with minor infections. It may be our number one cause of death in the USA. It is the cause of autoimmune disease such as diabetes, gout, Reiter's Syndrome, Lupus, fibromyalgia, and on and on...
I have hundreds of medical documents to back this while these clowns have what? One study? Two? I'd love to be on the drug company's side with this case. If argued properly they could waste those filing the lawsuit.
Interesting, thanks for the ping. Very interesting, thanks for the post.
http://www.rxlist.com/cgi/generic/alendron_wcp.htm#P
Alendronate Sodium (Fosamax) Dental Precaution
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.
Unfortunately this is not the case - if it was there could be something to do about it.
Only a fraction of the severe cases have had the necrotic area sampled (correctly) and cultured in which there were no signs of microbial pathology.
This appears to be more of an aseptic necrosis in which there is an upregulation of osteoclasts along with some kind of anti-angiogenesis.
The incidence of necrosis is far greater when the biphosphonates are administered by intravenous injection - that doesnt make much sense to me. Millions of people are on biphosphonates and this is a very rare adverse event - and an odd one.
My wife (age 67) has been taking Fosamax for almost 4 years for mild osteoporosis, diagnosed by a DEXA scan. Last year she was treated for breast cancer by surgery, aggressive chemotherapy (dose-dense Adriamycin-Cytoxan (4x) and Taxol-Gemzar (4x)), radiation, and now Aromasin, which she will take for at least 5 years.
Her oncologist had her stop taking aspirin, Lipitor, and Celebrex, (resumed after her active treatment) but insisted that she continue Fosamax without interruption due to the side effects of the chemo. He asked about any dental work she might need, and urged her to get it done beforehand if possible. And when she lost a crown during the month between chemo and radiation, he immediately prescribed a course of antibiotics that continued during her dental work.
But I find this very worrying. She must continue on an aromatase inhibitor because her cancer was ER+, but it seems to have caused something like menopause redux, complete with hot flashes, chills, and moods - and as the doctor warned, more likelihood of osteoporosis.
What should she do about dental work? Suspend Fosamax for a week, or two, or three, or...? Use prophylactic antibiotics, as she did during active cancer treatment? Or just ignore it, and hope for the best. My wife needs a broken wisdom tooth removed right now, but how should she minimize her risk of complications?
I am not an alarmist, but I AM afraid that my wife's health is threatened by multiple, convergent risk factors, and I need better answers than I have right now. We have an elderly friend (82) with severe spinal curvature due to osteoporosis, and don't want to have that happen either.
Several family members have had very, very serious side effects of antibiotics that could have been prevented.
Have you heard of leaky gut syndrome? Another result of C. difficile.
I know several people taking Fosamax, and they don't know about this. I'm going to print it out.
Thanks for the link!
If you have good health insurance she can switch to Forteo...it is an injectable drug that is very expensive but it has a different chemical basis than Fosomax and Actenol...I'm not sure if it's prescribed for mild osteoporosis...I had severe osteoporosis...this drug has no track record of osteonecrosis...I know this data because I recently had to have teeth extracted and I was on Actenol and had to get off it before the dental work could be done...I stopped taking it 2 months prior to my dental work so that it could leave my system completely...your wife should talk to her doctor and devise a strategy that works for her...like I said Forteo has a different composition but it is costly and the daily injections are emotionally trying...good luck
I went to the Orthopaedic doctor today, and there was a big sign on the wall promoting Fosamax. I gave him this article about Fosamax and osteonecrosis of the jaw, and he was surprised to hear about it. (He's a knee specialist on a large staff and is semi-retired.) He was pleased to receive it and thanked me.
Print for reference.
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