We have very little evidence to support ...

United States Food and Drug Administration advisers recommended Friday that osteoporosis drugs like Fosamax, Actonel, Boniva and Reclast come with the revised label, specifying how long the patient should take medicine before the potential health risks set inches of drugs known as bisphosphonates, which are taken to prevent fractures related to osteoporosis in postmenopausal women. But researchers have linked long-term use with little risk of unusual fractures of the femur, jaw death (necrosis of the jaw) and possibly cancer of the esophagus. For 6.17

voting advisors recommended drug labels - or loose - need to specify which details the best time to use each drug. But advisers do not offer specific changes in wording, label wording varies depending on the drug, reports Associated Press. The revised labels should be "very clear that the efficiency may drop after a period of time, maybe five years," commissioner Dr. Lewis Nelson, director of medical toxicology fellowship program, said after the vote

reported. "Serious problems have been raised about the risk and they must constantly evaluate how well."

FDA is not required to follow the recommendations of its advisory committees, as it usually does so buy lasix generic. According to the FDA, in 2009 more than 5 million prescriptions were filled for bisphosphonates to prevent bone loss. Dr. Elizabeth Shane, a former president of the American society for bone and mineral research, which was supposed to testify before the committee, said the reports due to atypical fractures, bisphosphonates and jaw necrosis "rarely, if viewed in the context of how many People taking bisphosphonates to treat osteoporosis. "It was" less confident in esophagus cancer problem, "she added. Although these side effects should not be exaggerated, "given the number of very dangerous, life-threatening fractures that prevent these drugs, the benefits dwarf side effects," said Shane, and professor of medicine at Columbia University in New York. However, she said bisphosphonates can be set only for those high risk of fractures. "In the past, we could use them to people who are not in such a high risk of fractures in the hope that they help prevent fractures in the area," she said. "We have moved against people with high short-term risk, which means the next five to 10 years."

According to Shane, the absolute risk of developing osteonecrosis of the jaw is between 1 in 10,000 and 1 in 400,000 among people taking these drugs for the treatment of osteoporosis. But when high doses of bisphosphonates used to slow the spread of cancer of the bones, the risk increases, affecting between 1 and 15 percent of patients, she said. For atypical femur (hip) fractures, the absolute risk associated with bisphosphonates is from 1 to 5 fractures 10000 users bisphosphonates, she said. In hip fracture, bisphosphonates prevent the spine, wrist and forearm fractures, said Shane. FDA requests the Advisory Committee to consider the current data support the long-term use of bisphosphonates for the treatment or prevention of osteoporosis. In addition, experts were to consider the feasibility of the term should be made to use drugs, and if patients who require long-term therapy would benefit from a "drug holiday" that time of medication. "I'm really not in favor of placing restrictions on the use of bisphosphonates and dictate the use of drug holidays," said Shane. "We have very little evidence to support use of drug holidays or vacations are not drugs."

Dr. Nelson Watts, director of the University of Cincinnati Bone Health and Osteoporosis Center and co-author of the study in 2010 on long-term use of bisphosphonates, said length of treatment should be considered on an individual basis. His study showed patients with mild risk can stop drug treatment over five years until it took fractures and bone loss was seen. With high-risk patients can take medicine for 10 years and may then take a "vacation" from bisphosphonates one or two years. "Perhaps it would be useful if the FDA or an official organization can provide guidelines concerning the duration of treatment, details of drug holidays, etc., but probably not enough information in the literature recommendations based on science," said W to vote Friday. General bisphosphonates are taken as pills or injections. They include: Fosamax (alendronate sodium), produced by Merck Co, Inc, Actonel and Atelvia (ryzedronat sodium), produced by Warner Chilcott, Boniva (ibandronat sodium) from Roche Therapeutics, Inc, and Reclast (zoledronovoyi acid) from << Corporation >>.