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Actonel, Boniva, Fosamax and similar bone drugs belong to a class of medications known as oral bisphosphonates. They are most commonly prescribed to postmenopausal women.

The study involved an analysis of data from a nationwide medical practice research registry in the UK, and followed about 90,000 people for 8 years. It included nearly 3,000 patients with esophageal cancer, 2,000 patients with stomach cancer, and 10,600 patients with colorectal cancer diagnosed between 1995 and 2005.

In people aged 60 to 70 who had 10 or more prescriptions for oral osteoporosis drugs for about 5 years, the study found the risk for developing esophageal cancer risk was 2 in 1,000. Normally, the risk of developing cancer of the esophagus, or throat, in people aged 60 to 79 is 1 in 1,000.

Researchers did not find any link between the drugs and stomach or bowel cancer.

According to a report on WebMD, this is not the first time drugs like Actonel, Boniva and Fosamax have raised cancer worries. A year and half ago, the US Food & Drug Administration (FDA) reported that there had been 23 cases of the cancer in Fosamax users in the US between 1995 and 2008. Another 31 cases of the cancer were reported among bisphosphonate users in Europe and Japan.

Since then, several more cases of esophageal cancer associated with bisphosphonate use have been reported to the FDA, bringing the total to 34, WebMD said.

The authors of this latest study did note that it was only observational and did not show that the osteoporosis drugs caused cancer. Just last month, a study published in the Journal of the American Medical Association that used the same data found that the medications were not linked to an increased risk of cancer. However, according to WebMD, the British Medical Journal study followed patients for nearly twice as long as the earlier one had.

Merck has already said it plans to appeal the verdict, and has called the damage award "excessive".

Fosamax is one of a number of drugs used to treat osteoporosis known as bisphosphonates. Other drugs in this class include Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa. In 2005, the Food & Drug Administration (FDA) ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ.

Since then, more than 1,200 plaintiff groups have filed 900 Fosamax lawsuits in courts around the country. About 771, including the Boles lawsuit, were consolidated before U.S. District Judge John Keenan in New York.

ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.

According to a Bloomberg report, Boles' case originally went to trial last August, but that proceeding ended in a mistrial after the jury was unable to return a verdict. The second trial began on June 7 with jury selection.

Boles, a retired deputy from the Okaloosa County, Florida Sheriff’s Office, testified that she began taking Fosamax after she developed a stress fracture in her foot, and eventually developed ONJ. Her lawsuit accused Merck of knowing about the Fosamax-ONJ connection as early as 1996.

Jurors on Friday found that Fosamax is defectively designed and unreasonably dangerous and that the drug was negligently designed, her lawyer told Bloomberg.

Boles' case was one of three "bellwether" trials scheduled by Judge Keenen in the Fosamax litigation. The first Fosamax case resulted in a Merck victory in May. The third trial is scheduled to begin in November.

Such trials are considered test cases, and often point the way to out-of-court settlements.

Oral bisphosphonates are used to prevent and treat osteoporosis in post-menopausal women. The drugs work by partially blocking the body's natural process involved in removing and rebuilding bone tissue. However, there are concerns that drugs like Fosamax could cause brittle bones over the long term that are more susceptible to fractures.

The FDA review was prompted by media reports linking Fosamax and the other drugs to atypical subtrochanteric femur fractures in some patients who've been on the drugs for several years. Such fractures occur in the bone just below the hip joint and can be extremely painful.

According to a report in The Wall Street Journal, two studies presented this week at the American Academy of Orthopaedic Surgeons' annual meeting suggest the drugs might adversely affect bone quality and increase risk of atypical fractures of the femur when used for four or more years. One study by researchers at Columbia University compared the bone structure of 61 postmenopausal women with osteoporosis who had been taking bisphosphonates for a minimum of four year to 50 similar patients taking calcium and vitamin D supplements. While patients using bisphosphonates did experience improvement early on, the researchers found that "after four years of use, these trends reversed, revealing an association between prolonged therapy and declining cortical bone structural integrity."

The second study, conducted by researchers at the Hospital for Special Surgery in New York, looked at bone samples taken from 21 post-menopausal women who were treated for femoral fractures. Of these, 12 patients had a history of bisphosphonate treatment for an average of 8.5 years, while nine women hadn't been treated with the drugs. According to The Wall Street Journal, the study found that the subjects taking bisphosphonates had a reduction in bone tissue heterogeneity compared with women not receiving the drugs, which suggests there might have been a difference in bone quality parameters.

According to a notice posted on the FDA's Web site, in June 2008 the agency requested information from all bisphosphonate drug manufacturers regarding the potential for atypical femur fractures. According to the FDA, a review of available data did not show an increase in this risk in women using these medications.

In announcing this safety review, the FDA said it would work closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.

The FDA has advised that healthcare professionals continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications, the agency said.

Oral bisphosphonates are used to prevent and treat osteoporosis in post-menopausal women. The drugs work by partially blocking the body's natural process involved in removing and rebuilding bone tissue. However, there are concerns that drugs like Fosamax could cause brittle bones over the long term that are more susceptible to fractures.

The FDA review was prompted by media reports linking Fosamax and the other drugs to atypical subtrochanteric femur fractures in some patients who've been on the drugs for several years. Such fractures occur in the bone just below the hip joint and can be extremely painful.

According to a report in The Wall Street Journal, two studies presented this week at the American Academy of Orthopaedic Surgeons' annual meeting suggest the drugs might adversely affect bone quality and increase risk of atypical fractures of the femur when used for four or more years. One study by researchers at Columbia University compared the bone structure of 61 postmenopausal women with osteoporosis who had been taking bisphosphonates for a minimum of four year to 50 similar patients taking calcium and vitamin D supplements. While patients using bisphosphonates did experience improvement early on, the researchers found that "after four years of use, these trends reversed, revealing an association between prolonged therapy and declining cortical bone structural integrity."

The second study, conducted by researchers at the Hospital for Special Surgery in New York, looked at bone samples taken from 21 post-menopausal women who were treated for femoral fractures. Of these, 12 patients had a history of bisphosphonate treatment for an average of 8.5 years, while nine women hadn't been treated with the drugs. According to The Wall Street Journal, the study found that the subjects taking bisphosphonates had a reduction in bone tissue heterogeneity compared with women not receiving the drugs, which suggests there might have been a difference in bone quality parameters.

According to a notice posted on the FDA's Web site, in June 2008 the agency requested information from all bisphosphonate drug manufacturers regarding the potential for atypical femur fractures. According to the FDA, a review of available data did not show an increase in this risk in women using these medications.

In announcing this safety review, the FDA said it would work closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.

The FDA has advised that healthcare professionals continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications, the agency said.

Fosamax is one of a number of drugs used to treat osteoporosis known as bisphosphonates. Bisphosphonates have been linked to a side effect known as Osteonecrosis of the Jaw (ONJ). Also known as Dead Jaw Syndrome, ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.

In 2005, the Food & Drug Administration (FDA) ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ. Since then, more than 1,200 plaintiff groups have filed 900 Fosamax lawsuits in courts around the country.

Merck & Co. had sought the dismissal of Fosamax lawsuits involving plaintiffs who had taken the drug for less than three years. But in his ruling, Judge Keenan wrote that whether there is a three- year threshold is a “genuine issue of fact for trial," Bloomberg.com said.

According to Reuters, Judge Keenan ruled that he would allow plaintiffs to introduce testimony by two doctors to show that the drug can cause jaw damage after less than three years of continuous use. The judge said that the evidence is sufficiently reliable to allow a rational jury to establish such a connection.

However, the judge also ruled that testimony of a third plaintiffs' expert would not be allowed because the witness had previously said Fosamax doesn’t cause ONJ in patients who take the drug for less than a three year period. According to Bloomberg.com, that witness - Dr. Robert Marx - began changing his stance on the three-year limit in 2008.

Meanwhile, Dow Jones is reporting that Judge Keenan has also called for a one-day cooling-off period in the first Fosamax lawsuit to go to trial after jury deliberations became tense. On Tuesday, Judge Keenan had asked jurors to continue deliberations after they indicated that they were at an impasse. But on Wednesday, an attorney for the plaintiff asked for a mistrial, saying one juror had indicated in a note that she was being intimidated and had been threatened, Dow Jones said. The juror's note claimed she had been the subject of threats of physical violence and had a chair thrown at her.

Fosamax is one of a number of drugs used to treat osteoporosis known as bisphosphonates. Other drugs in this class include Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa.

Bisphosphonates have been linked to a side effect known as Osteonecrosis of the Jaw (ONJ). Also known as Dead Jaw Syndrome, ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.

In 2005, the Food & Drug Administration (FDA) ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ. Since then, more than 1,200 plaintiff groups have filed 900 Fosamax lawsuits in courts around the country.

Plaintiffs in the lawsuits claim Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, Bloomberg.com said. They also claim that when Merck updated the label in 2005, the company still failed to adequately warn about the drug's risks. An attorney for some plaintiffs told Bloomberg.com that Merck was the only drug company not to use the language for the warning that the FDA requested

The first Fosamax lawsuit slated for trial involves a 71-year-old Florida woman who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006, Reuters said. According to the Reuters report, two other Fosamax lawsuits are scheduled to go to trial later this year, one in federal court and another in a state court in Alabama.

Reuters reports that Diane Wysowski of the FDA's drug risk assessment division advised researchers to review links between bisphosphonates and an increased cancer risk. � Health Day News explained that bisphosphonates are used to reduce the risk of bone fracture, while increasing bone mass in patients suffering from osteoporosis and are used to decelerate bone "turnover" in cancer patients whose disease reached the bones as well as those suffering from multiple myeloma, a type of blood cancer. � Bisphosphonates such as Fosamax have also been linked to an increased risk of atrial fibrillation, thigh bone fractures, and inflammatory eye disease, said HealthDayNews.

Wysowski discussed a letter in yesterday’s New England Journal of Medicine in which 23 patients developing esophageal tumors have been reported since Fosamax was first marketed in 1995, says Reuters; eight patients died. � Wysowski added, said Reuters, there seems to be a two-year period between initiating Fosamax and developing the cancer. � Also, said Reuters, in Europe and Japan, 21 cases involving Fosamax have been reported with six cases linked to Procter & Gamble's Actonel (risedronate) and Didronel (etidronate), and Roche's Boniva (ibandronate); six patients have died.

Fosamax and other bisphosphonates treatment involves patients remaining upright for at least one-half hour following dosing because of the well-established side effect of esophagitis, inflammation of the esophagus, reports Reuters. � Wysowski also warned physicians should not prescribe bisphosphonates to patients with Barrett's esophagus, a condition in which an esophageal change common in acid reflux patients occurs and that is also known to increase cancer risks, added Reuters.

Meanwhile, HealthDayNews reports that oral osteoporosis drugs are linked, in much greater incidence than was first believed to osteonecrosis of the jaw (ONJ); the risk is increased with the higher-dose intravenous (IV) form of bisphosphonates. � Dr. Parish Sedghizadeh, an assistant professor of clinical dentistry at the University of Southern California School of Dentistry in Los Angeles, told HealthDayNews that his clinic has seen a seriously marked increase in such cases: � In the past the clinic would see one case annually and is now seeing one to four cases weekly.

The findings prompted his investigation and are published in yesterday’s Journal of the American Dental Association, said HealthDayNews. � According to HealthDayNews, OSJ is known to cause pain, soft-tissue swelling, infection, loose teeth, and exposed bone and can occur in patients taking Fosamax as short as one year and tends to occur following invasive dental work.

Last year, the FDA posted an alert on its Website stating that patients being treated with bisphosphonates might develop “disabling pain” in the muscles, joints, and bones—a known risk detailed in the warning label; in some cases, the pain is reported to be "incapacitating" for normal movement like walking. 

To investigate this risk, the team reviewed all 70 patients with femoral fractures who were admitted to their Level 1 trauma center 2002-2007. � The average patient was 75 years of age, the majority of the patients were women, and 25 patients—36 percent—were treated with alendronate. � Also, 19 of 20 patients suffering from the same fracture pattern were taking alendronate. � The other patient was later diagnosed with cancer. � The study also reported that the average duration of alendronate use was significantly longer in those with femoral stress fractures than in the six treated patients without this type of fracture, 6.9 years versus 2.5 years, respectively. � Otherwise, there were no significant differences in age, race, weight, or osteoporosis history among = those without and without this fracture patter.

Lane and his associates have called for more research to determine if this effect is associated with all bisphosphonate drugs and if it became apparent first with alendronate because this drug has been available for the longest time and is the most widely used. � Lane advises that, "physicians prescribing bisphosphonates for longer durations should monitor patients for indications of bone regeneration." Lane recommends that bisphosphonates be discontinued until levels return to normal if a blood test shows a low level of bone turnover.

Meanwhile, earlier this year Canadian researchers issued a warning that bisphosphonates, sold under the names of Didrocal, Actonel, and Fosamax can lead to bone necrosis, a painful and disfiguring condition that results in bone death. � The study found that such drugs almost tripled the risk of developing bone necrosis. � The study was conducted by researchers at the University of British Columbia (UBC) and McGill University and is the largest study of its kind into the connection between bone necrosis and specific brands of bisphosphonates: � Didrocal, Actonel, and Fosamax. � Prior to that warning, the U.S. Food and Drug Administration (FDA) issued a warning about bisphosphonates and its link to a higher possibility of severe and sometimes incapacitating bone, joint, and muscle pain. � "I think the study's important just basically to let the public know if they do experience any severe, unusual pain they could tell their health professional," said Dr. Mahyar Etminan, the principle investigator from the University of British Columbia.

Use of bisphosphonates has increased as the population has aged and Etminan reported that use will likely further increase due to a possible link between estrogen use and breast cancer, prompting women to switch from estrogen therapy to bisphosphonate therapy to stop bone fractures from occurring. � The drugs like Didrocal, Actonel, and Fosamax are also becoming easier to take, with once-a-month and once-a-year doses now available. 

Fosamax has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues. � One of the most serious is its association with ONJ. � In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition. � ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue.

Earlier this year, the FDA warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain. � The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. In October, the FDA announced it would be conducting a safety review of Fosamax and other osteoporosis drugs in its class, known as bisphosphonates, after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

Now a small, observational study published in the current issue of the "Journal of Orthopedic Trauma" of 70 patients who sustained low-energy femur fractures -which occur when someone falls from a standing height or less - indicates Fosamax might play a role in such injuries. The femur is the long bone of the thigh.

According to the Wall Street Journal, of the patients in the study, twenty-five patients (36%) were taking Fosamax on average for four years or more. The Fosamax patients’ fractures had some distinct characteristics: Nineteen (76%) of the 25 patients had a simple fracture with a straight line across the bone and a beak-like overhang on one side. Also, the patients’ bones didn’t look like typical osteoporotic bone; they � looked strong.

Andrew Neviaser, lead author of the paper and a third-year surgical resident at the Hospital for Special Surgery in N.Y., told The Wall Street Journal that the study indicates that doctors should be aware that some patients who take Fosamax are vulnerable to these types of fractures, and should closely monitor them.

This study is not the first time Fosamax has been linked to such fractures. � In March, the New England Journal of Medicine published a letter written by Joseph M. Lane, MD, chief of the metabolic bone disease service at New York Hospital and colleagues which � reported 15 cases of unusual bone fractures in postmenopausal women who had been taking Fosamax for more than five years. � These women had also suffered from fractures along the length of the femur after falls from standing position or lower. And ten of the patients also had a distinct and unusual fracture pattern. Those ten patients had been taking Fosamax for more than seven years on average; the other five patients averaged less than three years of Fosamax use. 

Osteoporosis drugs are known to carry a number of side effects, including Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the labels for Fosamax and similar drugs was updated to include warnings about ONJ.

The USC researchers said ONJ occurs � when bacteria-laden biofilms infect the jaw after the bone is exposed, typically because of a tooth extraction or injury. 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.

This is not the first time biofilms have been linked to serious side effects. � In 2006, Bausch & Lomb issued a worldwide recall of Renu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. � Earlier this year, researchers with the Center for Medical Mycology found the strain of Fusarium responsible for the Renu with MoistureLoc outbreak had the ability to form biofilms. � Biofilms are clusters of microbes held together by a glue like matrix. � � This structure made the Fusarium extremely resistant to contact lens solutions and the body’s own immune system.

Not all cells can form biofilms, and unfortunately for Renu victims, contact lens solutions are not required to be tested against microbes with this ability. � In fact, Renu with MoistureLoc and other contact lens solutions are tested against a rare type of fungus obtained from a patient in Nigeria in 1970s. 

Fosamax, manufactured by Merck, was approved by the Food & Drug Administration (FDA) in 1995, and is prescribed to treat osteoporosis and Paget's disease. Fosamax is a type of drug known as a bisphosphonate. � Fosamax is known to carry a number of side effects, including Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.

In January 2008, the FDA � warned that Fosamax had also been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain. � The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. � The severe musculoskeletal pain associated with Fosamax can occur within days, months, or years after starting treatment with the drug. � While some patients have experienced complete relief of symptoms after discontinuing Fosamax, others have reported that the pain continued. � The risk factors for and incidence of severe musculoskeletal pain associated with Fosamax are unknown.

Now, a study conducted by researchers at the University of Washington has found that treatment with Fosamax could double the risk of atrial fibrillation. � Atrial fibrillation - a chronic, irregular heartbeat - causes fatigue, dizziness and fainting, but it isn't life-threatening. � Women who had taken the drug had an 86% higher risk of atrial fibrillation than those who never took Fosamax, the study found. But these results � were far from conclusive, doctors say. Fosamax accounted for 3% of the atrial fibrillation cases, and 97% were the result of other causes. The researchers said their findings showed a need for more study on this potential Fosamax side effect.

The University of Washington study is not the first to link a bisphosphonate to atrial fibrillation. � The FDA is already looking into the risk, prompted by research published in the May 7 issue of the New England Journal of Medicine � that found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on bisphosphonates found that there appeared to be 50 percent more risk of the heart rhythm irregularity in women who took the drugs than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women. 

Bisphosphonates, sold under the brand names Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa, � are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonate drugs are used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously in higher doses and usually for longer periods of time.

A letter written by Joseph M. Lane, MD, chief of the metabolic bone disease service at New York Hospital and professor of special surgery at Weill Medical College of Cornell University and colleagues, � reports on 15 cases of unusual bone fractures in postmenopausal women who had been taking Fosamax for more than five years. All had fractures along the length of the femur, the long bone in the thigh, after falls from standing position or lower. Ten of the patients had a distinct and unusual fracture pattern. These patients had been taking Fosamax for more than seven years on average; the other five patients averaged less than three years of Fosamax use.

According to Dr. Lane, "People on prolonged bisphosphonates — and Fosamax is the only one we have seen so far — after five to seven years are at risk of fractures in the long bone of the leg. � They complained of thigh pain for months before the breaks. So it seems they start off with a stress fracture that is unrecognized, and it goes on to full fracture."

Other medical practitioners have reported similar side effects with long-term use of Fosamax and other bisphosphonates, and many are starting to recommend that such patients take "drug holidays." � This involves bisphosphonate patients who have been taking the drugs for four years going off of them for a year or two. � They return to treatment after it can be determined that bone turnover - the rate at which old bone is replaced by new - is increasing. � This practice is typical in Europe and in Australia, and is becoming more common in a growing number of U.S. bone centers.

Bisphosphonates have been linked to a variety of other safety problem, including Osteonecrosis of the Jaw (ONJ). � Also known as Dead Jaw Syndrome, ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.

Last October, the Food & Drug Administration (FDA) announced that it was reviewing bisphosphonates after studies showed patients taking the drugs ran a higher risk of irregular heartbeat. � Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

Then in January, the FDA warned that bisphosphonates had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain. � he FDA recommended that healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug. 

"I think the study's important just basically to let the public know if they do experience any severe, unusual pain they could tell their health professional," said Dr. Mahyar Etminan, the principle investigator from the University of British Columbia.

The incidence of bone necrosis is rare, diagnosed in about one in 20,000 people a year, but it is serious and extremely painful and does lead to permanent loss of the blood supply to the bones. � Without blood, the bone tissue dies and causes the bone to collapse. � If necrosis involves the bones near a joint, it often leads to collapse of the joint surface. � What happens is, "The drugs basically hang around in bone for a long period of time and cut off blood supply to the bone, which eventually dies off and becomes necrotic," Etminan explained.

The recent study was collaboration between UBC, The Vancouver Coastal Health Research Institute, and McGill University in Montreal and was based on the health records of 88,000 Quebec residents over a period of seven years. � The team decided to take on the research after academic papers began linking necrosis of the jaw with the use of bisphosphonates. � Etminan said the study allows patients and their doctors to look at the positives and negatives of taking this class of medication.

Meanwhile, use of bisphosphonates medications such as Didrocal, Actonel, and Fosamax has increased as the population has aged. � Etminan said that use will likely further increase due to a possible link between estrogen use and breast cancer, prompting women to switch from estrogen therapy to bisphosphonate therapy to stop bone fractures from occurring. � The drugs like Didrocal, Actonel, and Fosamax are also becoming easier to take, with once-a-month and once-a-year doses now available.

"Our study's take-home message is that you know if you experience severe pain, it may not be because of your osteoarthritis or even osteoporosis and just check it out and make sure it's nothing serious," he said.

The disease primarily affects the shoulders, knees, and hips at the joints. � Etminan said therapy for bone necrosis ranges from non-invasive treatments such as taking anti-inflammatories to invasive surgery involving total joint replacement, depending on the seriousness of the condition. 

Fosamax, a popular osteoporosis drug, has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues. � One of the most serious is its association with ONJ. � In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition. � ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: � jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.Hundreds of patients have sued Merck, claiming that their ONJ was caused by Fosamax. � Earlier this month, a federal judge refused to grant class action status to a group of ONJ lawsuit plaintiffs in Pennsylvania, Florida and Louisiana who wanted Merck to establish a Fosamax medical monitoring fund. � Because of the judge’s decision in this matter, it is expected that the number of Fosamax Dead Jaw Syndrome lawsuits currently making their way through the courts is likely to explode.

But ONJ isn’t the only problem associated with Fosamax. � Just a few weeks ago, the FDA warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain. � The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. In October, the FDA announced it would be conducting a safety review of Fosamax and other osteoporosis drugs in its class, known as bisphosphonates, after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

Despite its safety problems, Fosamax netted Merck sales of nearly $3 billion in 2007. � But the company’s patent protection on Fosamax runs out next month, meaning cheaper generic versions of the drug could soon cut into Merck’s sales. 

Fosamax, a popular osteoporosis drug, has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues. � One of the most serious is its association with ONJ or Dead Jaw Syndrome. � In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition. � ONJ is a disorder in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: � jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.

Earlier this week, the FDA warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain. � The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. In October, the FDA announced it would be conducting a safety review of Fosamax and other osteoporosis drugs in its class, known as bisphosphonates, after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

In a ruling dated last Thursday, U.S. District Judge John Keenan denied motions to approve classes of current and former users of the popular drug in Pennsylvania, Florida and Louisiana who have not been diagnosed with Dead Jaw Syndrome. "The court finds that class-treatment of these claims is inappropriate because they present too many individual questions of fact particular to each class member's claim," Keenan wrote in a 41-page ruling.

Had the motion for class action status been approved, current and former Fosamax users could have sued Merck for the costs of medical monitoring as a group, under one complaint. � � But now, they will have to seek Fosamax medical monitoring in individual lawsuits. � � Because of Judge Keenan’s ruling, it is now estimated that the number of Fosamax cases in federal and state courts would increase to 1,500 to 2,000 by the end of the year from roughly 460 now. � The first federal Fosamax cases are expected to go to trial at the end of the year, 

Bisphosphonate, sold under the brand names Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa, � are commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms of bisphosphonate drugs are used in the management of advanced cancers that have metastasized to the bone, where the disease often causes bone pain and possibly even fractures. Several cancers can involve or metastasize to the bone, including lung cancer, breast cancer, prostate cancer, multiple myeloma, and others. When bisphosphonates are given in cancer chemotherapy, the drugs are given intravenously in higher doses and usually for longer periods of time.

According to today’s FDA warning, the severe musculoskeletal pain associated with bisphosphonates may occur within days, months, or years after starting a bisphosphonate. � Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown. � The FDA recommended that healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

Bisphosphonates have been linked to a variety of other safety problems. � In October, the FDA announced that it was reviewing the drugs after studies showed patients taking bisphosphonates ran a higher risk of irregular heartbeat. � Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

Fosamax has also been linked to Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ. 

Bisphosphonates are used to increase bone mass and reduce fracture risk in patients with osteoporosis. They also are also used to slow bone turnover in patients with a disorder called Paget's disease and to treat bone metastases and lower blood calcium in cancer patients. There are currently 8 bisphosphonates approved for use in the US. They are Fosamax, Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.

Research published in the May 7 issue of the New England Journal of Medicine found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on Fosamax found that there appeared to be 50 percent more risk of the serious heart rhythm irregularities in women who took the daily pill than among those who didn't take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.

A second study published in the same issue of the New England Journal of Medicine cast doubt on another bisphosphonate, Reclast. In a study of 7,736 postmenopausal women with bone-thinning osteoporosis, the risk of a serious case of irregular heart rhythm was more than double that in the other patients.

In announcing the bisphosphonate safety review, the FDA said that it was “unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time." The agency will be seeking additional data on the possible atrial fibrillation risks associated with these drugs, and it expects the safety review of bisphosphonates to take about 12 months.

This is not the first time that the safety of Fosamax has been questioned. The drug has been linked to Osteonecrosis of the Jaw (ONJ), also known as Dead Jaw Syndrome, a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. In 2005, the Fosamax label was updated to include warnings about ONJ.