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More Research Points to Long-Term Ills With Bone Drugs

Posted 6 days ago by Drugs.com

MONDAY, May 21 – Adding more weight to concerns about possible long-term dangers of osteoporosis drugs, a new study finds that people who take the drugs, known as bisphosphonates, may be at increased risk for atypical fractures of the thigh bone (femur). Osteoporosis is a bone-thinning disease that is common in older women. An atypical femoral fracture is an unusual type of break that often occurs spontaneously, without any major leg injury. In the new study, Swiss researchers looked at 477 patients, aged 50 and older, who were hospitalized with a femoral fracture. Of those patients, 39 had atypical fractures and 438 had a classic fracture (a more common fracture with a typical pattern). These groups were compared with 200 people without femoral fractures. The findings were published online May 21 in the journal Archives of Internal Medicine. The investigators found that 82 percent of ... Read more

Osteoporosis Drugs May Lead to Eye Trouble: Study

Posted 2 Apr 2012 by Drugs.com

MONDAY, April 2 – First-time users of osteoporosis drugs called oral bisphosphonates may be at increased risk for serious inflammatory eye disease, a new study contends. Oral bisphosphonates, such as Fosamax and Actonel, are the most commonly prescribed class of drugs to prevent or slow osteoporosis, a disease that causes very weak bones. Previous studies have linked the drugs to problems such as unusual fractures, irregular heartbeat and esophageal and colon cancer. In addition, some case reports have shown an association between the drugs and inflammatory eye diseases – anterior uveitis and scleritis – that can cause serious vision impairment. In this new study, Canadian researchers compared nearly 11,000 first-time users of oral bisphosphonates and more than 920,000 non-users. First-time users had incidence rates of 29 per 10,000 person-years for uveitis and 63 per 10,000 ... Read more

FDA Approves Binosto, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution

Posted 15 Mar 2012 by Drugs.com

FREIENBACH, Switzerland, March 14, 2012 /PRNewswire/ – EffRx Pharmaceuticals SA today announced that the U.S. Food and Drug Administration (FDA) has approved Binosto (alendronate sodium) Effervescent Tablets, previously known as EX101, for the treatment of osteoporosis in postmenopausal women, and as a treatment to increase bone mass in men with osteoporosis. EffRx anticipates that Binosto will be commercially available in the United States in the third quarter of 2012. Christer Rosen, Chairman & CEO of EffRx states: "We are very pleased to receive this approval from the FDA. Binosto is a breakthrough innovation for the treatment of osteoporosis, offering those patients who have difficulty with tablets the proven fracture risk reduction of alendronate in a pleasant tasting and easy-to-swallow buffered solution." Osteoporosis affects more than 200 million people in the 7 major markets ... Read more

Related support groups: Osteoporosis, Alendronate

Stopping Bone Drug Cuts Risk of Second Thigh Fracture: Study

Posted 9 Feb 2012 by Drugs.com

THURSDAY, Feb. 9 – People who suffer a rare type of fracture of the thigh bone while taking bone-building drugs known as bisphosphonates can cut the risk of a second fracture by discontinuing the medication, a new study says. Bisphosphonates such as Fosamax, Boniva and Actonel are often prescribed for postmenopausal women or people taking steroid medications to prevent or slow the bone-weakening disease osteoporosis. But the drugs have been linked to a small risk of unusual fractures of the femur. One out of 1,000 taking the drugs for six years will suffer such a fracture, the researchers said. For the study, the researchers examined femur fracture records for patients older than 45 from a large California insurer. Over two years, they found 126 patients reportedly taking bisphosphonates suffered an atypical femur fracture. Of those patients, 41.2 percent who continued taking the drugs ... Read more

Osteoporosis Drugs' Safety Subject of FDA Panel

Posted 9 Sep 2011 by Drugs.com

FRIDAY, Sept. 9 – Experts convened by the U.S. Food and Drug Administration were to meet Friday to discuss problems linked to long-term use of bone-building drugs such as Fosamax, Actonel, Boniva and Reclast. These drugs, known as bisphosphonates, are taken to prevent fractures related to postmenopausal osteoporosis. But researchers have linked long-term use with a small risk of unusual fractures of the thigh bone, death of the jawbone (osteonecrosis of the jaw) and possibly esophageal cancer. Members of two FDA advisory committees are expected to weigh the drugs' risks and benefits and possibly come up with new recommendations regarding their use. According to the FDA, in 2009 more than 5 million prescriptions were filled for bisphosphonates, which inhibit bone loss. Dr. Elizabeth Shane, past president of the American Society for Bone and Mineral Research, who is scheduled to testify ... Read more

FDA Medwatch Alert: Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer

Posted 21 Jul 2011 by Drugs.com

Includes: Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), and Skelid (tiludronate) ISSUE: FDA notified healthcare professionals and patients about its ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus. FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer. There are insufficient data to recommend endoscopic screening of asymptomatic patients. FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available. BACKGROUND: Oral bisphosphonates are commonly used for the prevention and treatment of osteoporosis as well as to treat other bone ... Read more

Study Finds Slight Risk of Rare Fractures From Bone Drugs

Posted 4 May 2011 by Drugs.com

WEDNESDAY, May 4 – Bone-building drugs called bisphosphonates have been linked to rare fractures of the thigh bone, but Swedish researchers report that the risk is so small that most patients needn't worry. Bisphosphonates include the widely used medications Fosamax, Boniva and Actonel, which are typically taken by people with osteoporosis to increase bone strength and prevent fractures. "Osteoporotic fractures are quite common and bisphosphonates reduce this risk a lot, but the price you have to pay for that is a small risk in getting a so-called fatigue fracture," said lead researcher Dr. Per Aspenberg, a professor of orthopedics at Linkoping University. "These findings must be seen in the context of the debate that has been going on for the past year," he added. "Our data argues very strongly for a causal relationship." However, the risk of getting an atypical fracture is similar to ... Read more

Study Suggests Osteoporosis Drug Might Treat Loss of Bone in Jaw

Posted 17 Oct 2010 by Drugs.com

SATURDAY, Oct. 15 – People suffering from a disfiguring loss of bone in the jaw may find help in the form of a long-used osteoporosis drug, two new studies suggest. Besides being linked to chronic, severe gum disease, this type of bone loss has also been connected in rare cases to the use of bisphosphonates, a different class of osteoporosis drugs. But the two papers in the Oct. 16 online issue of the New England Journal of Medicine report success with teriparatide (Forteo) in rebuilding bone. One report describes the case of an 88-year-old woman who had been taking the bisphosphonate alendronate (Fosamax) since suffering a hip fracture 10 years earlier. She had also been taking the corticosteroid prednisone for two decades. Experts have already noticed an uptick in the incidence of this rare but devastating condition in patients using bisphosphonates. According to an editorial ... Read more

Cancer-Fighting Bone Drugs Might Raise Stroke Risk

Posted 12 Oct 2010 by Drugs.com

TUESDAY, Oct. 12 – A new study finds that cancer patients treated with bisphosphonate drugs such as Aredia or Zometa to reduce or delay bone complications from cancer may be at higher risk for the irregular heartbeat known as atrial fibrillation and for a related event, stroke. In atrial fibrillation, the upper chambers of the heart beat chaotically, causing blood to pool and increasing the potential of clots, stroke, heart failure and death. However, the bump up in risk with bisphosphonates was "relatively modest," said Dr. James Goodwin, senior author of a paper appearing online Oct. 12 in the Journal of Clinical Oncology. At relatively low doses, bisphosphonates have been widely used for about three decades to treat osteoporosis, mainly in older women. Then, "in the 1990s, it was discovered that they had a rather miraculous effect in terms of either treating or preventing metastases ... Read more

Expert Panel Links Popular Bone Drugs to Rare Fracture

Posted 14 Sep 2010 by Drugs.com

TUESDAY, Sept. 14 – An expert panel concludes that bone-strengthening bisphosphonate drugs such as Actonel, Boniva and Fosamax can actually raise risks for a rare type of fracture of the thighbone. The panel is urging the U.S. Food and Drug Administration – which has been awaiting the report – to add a special warning to that effect on the drugs' labeling. "Bisphosphonates may be related to atypical femur fractures," said Dr. Elizabeth Shane, a professor of medicine at Columbia University's College of Physicians and Surgeons in New York City. She is the lead author of the report, which was compiled by a special task force at the American Society for Bone and Mineral Research. "These fractures are very unusual," Shane added. "But we are still concerned that patients could still have these fractures. There may well be a link between these fractures and bisphosphonates." The FDA has ... Read more

Long-Term Use of Bone Drugs May Be Linked to Esophageal Cancer

Posted 3 Sep 2010 by Drugs.com

THURSDAY, Sept. 2 – People with osteoporosis who take drugs such as Boniva (ibandronate), Fosamax (alendronate) or Actonel (risedronate) to strengthen their bones may be at an increased risk of esophageal cancer, British researchers report. This class of medicines, called oral bisphosphonates, are the most commonly used drugs to treat osteoporosis and other bone diseases. While anecdotal reports have suggested that they may increase the risk of esophageal cancer, the scientific evidence has been limited, the researchers noted. "What we lack at present is a full picture of the benefits versus risks for long-term use of bisphosphonates, which are increasingly commonly prescribed," said lead researcher Dr. Jane Green, a clinical epidemiologist, in the Oxford University's Cancer Epidemiology Unit. "Our results are a small part of this picture." There are no immediate implications for ... Read more

No Significant Esophageal Cancer Risk From Osteoporosis Drug: Study

Posted 10 Aug 2010 by Drugs.com

TUESDAY, Aug. 10 – People who take oral bisphosphonate drugs to prevent or treat osteoporosis are not at a significantly increased risk for esophageal or stomach cancer, according to an analysis of more than 80,000 patients in the United Kingdom. The use of oral bisphosphonates has increased dramatically in recent years in the United States and other Western countries, and some recent reports have suggested a link between the drugs and esophageal cancer. In the study, researchers analyzed data from 41,826 women and men, average age 70, who took oral bisphosphonates between January 1996 and December 2006, and a control group of an equal number who didn't take the drugs. (Eighty-one percent of the participants were women.) During an average follow-up of about 4.5 years, there were 37 cases of stomach cancer and 79 cases of esophageal cancer diagnosed in the bisphosphonate group, compared ... Read more

Bone-Building Pills Appear to Lower Invasive Breast Cancer Risk

Posted 24 Jun 2010 by Drugs.com

THURSDAY, June 24 – Bone-building drugs known as bisphosphonates appear to reduce the risk of invasive breast cancer by around 30 percent, two new studies show. "If a woman is considering bisphosphonate use for bone, this might be another potential benefit," said Dr. Rowan T. Chlebowski, a clinical oncologist at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center in Torrance, Calif. He is the lead author of one of the two studies on the topic, published online this week in the Journal of Clinical Oncology. The findings were first presented late last year at the San Antonio Breast Cancer Symposium, but Chlebowski said the results now have the benefit of having been peer-reviewed before publication for scientific accuracy. Chlebowski and his colleagues looked at nearly 155,000 women who participated in the Women's Health Initiative (WHI) study, evaluating the ... Read more

Bone Drugs Not Linked to Rare Fractures

Posted 12 May 2010 by Drugs.com

WEDNESDAY, May 12 – A new study finds no association between the use of a popular class of osteoporosis medications known as bisphosphonates and an unusual type of thigh bone fracture. Bisphosphonates include blockbuster drugs such as alendronate (Fosamax), risedronate (Actonel) and ibandronate (Boniva). The conclusions, appearing as a letter-to-the-editor in the May 13 issue of the New England Journal of Medicine, do little to settle an ongoing debate about whether or not these drugs cause this type of rare fracture. A pharmaceutical-company sponsored study published in March in the same journal concluded that bisphosphonates did not boost people's risk for this type of fracture, although prior studies had suggested they did. That "very large study," said Dr. Kenneth A. Egol, chief of the Orthopaedic Trauma Service at New York University Hospital for Joint Diseases, "certainly can ... Read more