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.
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.
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.
Around the same time, Dr. Ruggiero, a maxillofacial surgeon at Long Island Jewish Hospital, noticed that numerous osteoporosis patients taking bisphosphonates had developed osteonecrosis of the jaw. In 2004, he published a report on 63 patients diagnosed with the condition; 56 had cancer and seven had osteoporosis. The number of reported cases is still quite small, but because bisphosphonates stay in the bone for a long period of time, some researchers expect the number of cases to increase dramatically.
Symptoms of osteonecrosis of the jaw include: pain, swelling, gum infections, drainage, jaw infections, loose teeth, jaw numbness, and exposed bone. The American Dental Association recommends notifying your physician or dentist immediately if you have taken a bisphosphonate medication and experienced any of these symptoms. The ADA also recommends that patients tell their physicians and dentists that they are taking bisphosphonate medications before any dental work is performed.