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Posts Tagged ‘dental procedures’

Fosamax-Induced Osteonecrosis of the Jaw More Common Than Previously Thought

Posted by medconsumers on March 1, 2009

Dentists have been in the forefront of identifying a severe complication of Fosamax, the osteoporosis drug widely prescribed to prevent fractures. The January issue of the Journal of the American Dental Association published a study describing a significant risk of osteonecrosis of the jaw from even oral use of Fosamax. Until this small study of 208 dental patients was published, jaw osteonecrosis was thought to be rare and limited to people with cancer who received large doses of Fosamax intravenously to treat bone metastases.

Dental School Patients Studied

In this study conducted at the University of Southern California School of Dentistry, 4% of the dental patients taking oral Fosamax had osteonecrosis of the jaw. All had suffered dental trauma—either a tooth extraction or ill-fitting dentures that resulted in jawbone exposure; all were women, average age 73 years, who had been taking the drug for 12 months or longer. Osteonecrosis is defined as “the presence of exposed bone in the mouth, which fails to heal after appropriate intervention over a period of six or eight weeks.”

Parish P. Sedghizadeh, DDS, and colleagues at the USC School of Dentistry found no cases of osteonecrosis of the jaw among their 4,384 dental patients not taking Fosamax who underwent tooth extraction. Fosamax was the first and most aggressively promoted of all drugs in a class called bisphosphonates, which also includes Actonel, Boniva, Aredia, Zometa and Bonefos.

4% Risk is Not Rare

Sedghizadeh and colleagues say their findings contradict Merck’s claim that jaw osteonecrosis is a rare side effect of its drug. “We have been told that the risk with oral bisphosphates is negligible, but 4% is not negligible,” said Dr. Sedghizadeh. (The benefit of Fosamax could also be described as rare because the drug reduces the risk of hip fracture from 2% to 1%, as demonstrated in premarketing trials.) Prior to receiving FDA approval, Fosamax was tested in trials that lasted only three to five years. Ever since this drug first came on the market in 1996, the unanswered question has been: How long can people safely take Fosamax—or any one of other bisphosphonates, which are known to suppress bone turnover.

Drugs Have a Long Half-Life

This warning came from the USC Dental School research team: Bisphosphonates have half-lives of ten years or more, and people taking the drug orally may ultimately reach the same high dose level as that given intravenously to treat bone metastases in cancer patients. Sedghizadeh and colleagues also explained that because bisphosphonates stay in the bone for a long time, the risk of osteonecrosis remains even after people go off the drugs. The half-life of a drug describes how long it takes for half of it to be eliminated from the bloodstream.

The USC study is not the last word on the frequency of osteonecrosis of the jaw in people taking bisphosphonates. A much larger study is needed; ideally, one that takes place in many dental schools. Researchers at other institutions are trying to determine the prevalence of osteonecrosis of the jaw in cancer patients treated with bisphosphonates for cancer metastases. In the journal Bone, Dr. I.R. Reid, University of Auckland, estimated that it is 5% among people with myeloma, breast cancer or prostate cancer.

What to do

Thirteen years after Fosamax was launched, severe adverse effects have been showing up that may not be as rare as the public has been led to believe. Last year, the FDA reported that all bisphosphonates carry the risk of severe and sometimes incapacitating musculoskeletal pain. And case reports in several medical journals describe an unusual type of severe fracture of the femur associated with bisphosphonate use. In 2007 an increase in serious cases of atrial fibrillation was reported in people given the relatively new once-a-year bisphosphonate injection for fracture prevention (Zometa).

Osteonecrosis Treatments

As for osteoporosis of the jaw, more information is needed about how to prevent and treat it successfully—if that’s possible. Sedghizadeh and colleagues at USC Dental School did not have too much to offer on this topic. They advise unnamed alternate treatment options be considered for “nonnecessary extractions;” reducing the amount of the bacteria with a chlorhexidine rinse for those who must undergo a procedure; and daily antibiotics for those with denture trauma. For the exposed bone that fails to heal, the researchers name a procedure called “mucosal coverage.”

University of New Zealand’s Dr. Reid put it more succinctly “Management focuses on prevention, treatment of infection and cessation of bisphosphonate. The role of surgery is unclear.”

For more information: Read my 2008 article about Fosamax and this 2008 article about Evista. For an overview of how the definition of osteoporosis was expanded by the pharmaceutical industry: read “The marketing of osteoporosis: how a risk factor became a disease,” which appeared in the April 2009 issue of the American Journal of Nursing.

Maryann Napoli, Center for Medical Consumers©

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Antibiotics Prior to Dental Procedures: Big Change in Recommendations

Posted by medconsumers on July 1, 2007

For over a half century, millions of Americans with common heart valve problems, such as mitral-value prolapse, were told to start taking preventive antibiotics prior to undergoing routine dental procedures. To ignore this standard recommendation is to risk a potentially life-threatening case of bacterial endocarditis triggered by the dental procedure. Or so went a widely held belief that has been revised recently by the American Heart Association.

The AHA now restricts its preventive antibiotics advice to a much smaller group of people—those with serious heart conditions. The new guidelines were published recently in the journal, Circulation, where the AHA acknowledged its longstanding policy was based on expert opinion rather than evidence.

The AHA appointed a writing group comprised of people selected for their expertise in the prevention and treatment of endocarditis. After reviewing all relevant studies, the AHA writing group concluded that the odds of suffering a serious adverse reaction to the antibiotics are higher for most people with heart conditions than their odds of getting endocarditis due to a dental procedure. In other words, endocarditis is a rare possibility. This is similar to the conclusion of a 2004 review of all relevant studies on this topic conducted by the Cochrane Collaboration.

Central to the now-outdated AHA recommendations was the concern that even the most routine of dental procedures, such as tooth scaling, could let loose bacteria into the bloodstream. Theoretically, the bacteria would lodge on abnormal heart valves or other damaged heart tissue and cause endocarditis, an infection of the heart’s inner lining (endocardium) Ironically, the AHA guideline writers said that the chances of developing endocarditis from the more mundane everyday activities, such as tooth brushing, flossing, and use of toothpicks, are higher than getting it during a dental procedure.

On another ironic note, the AHA writing group found that studies involving the antibiotics typically prescribed before dental procedures—penicillin or amoxicillin—failed to prove that either drug is effective in reducing the release of bacteria into the bloodstream. (The studies had compared drug-treated people with untreated people who underwent the same dental procedures.) Also, there is no evidence to show that amoxicillin, the antibiotic of choice since 1990, can reduce the risk of or prevent endocarditis.

The new AHA guidelines now confine preventive antibiotics to people at the very highest risk for endocarditis, including those who have had the disease, and those with a prosthetic heart valve, congenital heart disease, hypertrophic cardiomyopathy or cardiac valvulopathy (after heart transplant). A single antibiotic dose before the dental procedure is sufficient for people in these circumstances.

Mitral Valve Prolapse

People with mitral valve prolapse (MVP), estimated to be about 18% of the population, are now freed from the need to take preventive antibiotics. The AHA writing group noted that the incidence of endocarditis is extremely low in the entire population of people with MVP. Moreover, the disease does not have the same deadly consequences in people with MVP as it does for those with the above-mentioned highest risks.

Bottom Line: A 50-year-old health policy without much supporting evidence has been revised. For most people with heart valve problems, antibiotics before a dental procedure pose more of a threat to health than the rare possibility of developing endocarditis. Furthermore, there is no evidence to show that antibiotics can reduce the risk of endocarditis. The American Dental Association endorsed the new guidelines.

Maryann Napoli, Center for Medical Consumers ©
July 2007

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Low-Dose Aspirin for Heart Protection: How Low Should a Safe Dose Be?

Posted by medconsumers on June 1, 2007

Daily aspirin protects the heart, but the dose at which this can be safely accomplished has never been established. It has long been known that the risks of aspirin—gastrointestinal or brain hemorrhage—cannot be completely eliminated even at the lowest possible doses. An international team of researchers recently determined that daily doses of aspirin as low as 30 mg are adequate for achieving the anti-clotting goal; whereas doses higher than 75 to 81 mg merely increase the risk of adverse reactions without providing any additional advantage.

The research team led by Charles L. Campbell, MD, University of Kentucky, based its conclusions on a review of 11 studies comparing people on different low doses of aspirin after a major stroke, a minor stroke (transient ischemic attack), a heart attack or a recent artery-opening procedure. It was published last month in the Journal of the American Medical Association.

The 11 studies had a combined total of about 47,000 participants (one-third were women) who were followed up to four years. The aspirin doses given in these studies, ranged from 30 mg/daily to 650 mg/ twice daily. Though millions of Americans take low-dose aspirin to prevent cardiovascular problems from occurring in the first place, no studies in this review included participants without heart disease.

Dr. Campbell, the lead author of the review was asked by e-mail how low a dose should be taken by people without heart disease, who were not addressed in this review. “The lowest dose I have seen evaluated in the primary prevention setting was 100 mg every-other-day in the Women’s Health Study,” he responded, referring to a 2005 trial that found, even at that low dose the women on aspirin had a higher rate of gastrointestinal bleeding than the women on placebos.

“I typically use 81 mg of uncoated aspirin for primary prevention in either men or women, but would not object to using lower doses among women.” (Enteric-coated products were questioned by Dr. Campbell and colleagues because they are not absorbed as well as plain aspirin.)

“I suspect the patients I recommend primary prevention for are of higher risk than the majority of women in the Women’s Health Study (more than 40% of whom had NO traditional risk factors for coronary disease),” wrote Dr. Campbell in an e-mail. “My patients are more like the over-65 population in the Women’s Health Study where low-dose aspirin was associated with a reduction in MI [heart attack]. I typically avoid alternate day dosing to keep things simple and compliance high, but don’t have a philosophical objection to that approach either.”

Aspirin is a non-steroidal anti-inflammatory drug. Though gastrointestinal bleeding is usually attributed to other drugs in this class like ibuprofen and naproxen, this adverse reaction was most often caused by aspirin in one study that looked at 18,820 hospitalized patients. Of the 1225 patients admitted as a result of adverse drug reactions, low-dose aspirin was identified as one of the most common causes, with 18% of hospitalizations and 61% of the fatal cases associated with low-dose aspirin.

Bottom line:

The conclusion of this review contradicts the typical dosage recommendation in the U.S.—between 81 mg and 325 mg. A baby aspirin (81 mg) a day is a sufficient dose for protection for people with heart disease. People without heart disease were not represented in this review, but the lead author suggests 81 mg uncoated aspirin daily, though a lower dose could be appropriate for women. No primary prevention trial has had participants taking an aspirin dose lower than 100 mg every other day.

Maryann Napoli, Center for Medical Consumers ©
June 2007

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Antibiotics Before Dental Procedures

Posted by medconsumers on April 1, 2005

Should People with Heart Valve Problems Take Antibiotics Before Invasive Dental Procedures?

People with heart valve problems are told to take antibiotics before certain dental procedures in order to prevent bacterial endocarditis. This disease can be triggered by bacteria disrupted by tooth scaling, dental implantation, and other invasive procedures. The bacteria goes into the bloodstream and become lodged in the innermost layers of the damaged heart valves. It is potentially fatal and can be well underway before symptoms ever appear. To treat after the fact might very well be too late. But antibiotic therapy in itself can cause harm. And some researchers have questioned the universal preventive antibiotics recommendation because bacterial endocarditis is an uncommon disease.

For a 2004 Cochrane* review entitled, “Penicillins for the prophylaxis of bacterial endocarditis in dentistry,” R. Oliver and colleagues searched the published medical literature to find studies that proved the benefits of preventive antibiotics outweigh the harm for high-risk people facing an invasive dental procedure. All that could be found was one case-control study conducted in The Netherlands, and its results are inconclusive.

The Cochrane reviewers also found a population study published in 2000 in the American cardiac journal, Circulation that quantified the risk of bacterial endocarditis and the risk of taking antibiotics. It estimated that people taking penicillin were five times more likely to die from an allergic reaction to this antibiotic than from endocarditis.

The Cochrane authors concluded: “There is no evidence about whether penicillin prophylaxis is effective against bacterial endocarditis in people at risk who are about to undergo an invasive dental procedure. There is a lack of evidence to support published guidelines in this area. It is not clear whether potential harms and costs of penicillin administration outweigh any beneficial effect. Ethically practitioners need to discuss the potential benefits and harms of antibiotic prophylaxis with their patients before a decision is made about administration.”

*The abstracts from all Cochrane reviews are available at www.thecochranelibrary.com . See “Penicillins for the prophylaxis of bacterial endocarditis in dentistry”.

Maryann Napoli, Center for Medical Consumers ©
April 2005

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