This study randomized women who like to

Labels on bisphosphonates, such as >> << is used to treat and prevent osteoporosis, should further clarify how long patients can take them, FDA Advisory Group voted today. But the panel retreated to give any specific dates. Bisphosphonates include Aclasta, Actonel, Altevia, Боніва, Fosamax, and. Four million to five million Americans fill

drug each year, according to FDA

FDA convened a meeting because of emerging safety problems associated with long-term use - usually considered to be more than 4:57 years - bisphosphonates. In particular, the agency received reports of osteonecrosis or bone death and jaw >> << unusual femur or thigh bone, in women who took drugs for several years or more. Meanwhile, some studies show that as bisphosphonates remain in bones for many years, women can still benefit after they stop taking them. Additional information about the label panel, consisting of the Advisory Committee on Drugs Reproductive health and safety of medicines and Risk Management Advisory Committee voted 17 to 6 in favor to recommend additional information on the labeling of drugs long-term safety and efficacy. FDA usually, but not always follow the recommendations of its advisory committee. Own analysis of the agency concluded that women who continue to bisphosphonates therapy after five years of operation there are obvious benefits or harm and no evidence of a subgroup of patients who have "a clear and consistent" to reduce the risk of fractures, FDA scientist Teresa Keho , MD, told the panel. Bisphosphonates labels indicate that the effectiveness and safety information on the basis of one to four years - depending on the drugs - these clinical trials Keho said, but the optimal length of use is unknown. "It's really a problem that is in the center of the room and primary care," said Douglas Bauer, MD, University of California, San Francisco, the main doctor asked the FDA for the Consultative Group. Although not ideal to study the long-term use, the only published study to make it part Fosamax, said Bauer. This study randomized women who like to take Fosamax daily for five years in clinical trials or to continue receiving the drug for another five years or to stop. For fractures other than those of the spine, there is no evidence of overall benefit continuation within five years, said Bauer. But it was 55% lower risk of spine fractures in women who continued taking Fosamax for an additional five years, said Arthur Santoro, executive director of clinical research for the

and Endocrinology Drug Merck, which makes the drug. In the study to 10 years of use, Santoro said there were no reports of death of the jaw and no difference in risk of hip fractures unusual women who took drugs and those who did not. Long-term use of Bisphosphonates Experts said it is difficult to predict which women will benefit from long-term use of bisphosphonates lasix 240 mg. Fosamax study found that women bone mineral density at the time they stopped the drug closely related to their risk of fracture over the next five years, Bauer told the group. The data probably can be summarized in a weekly dosage Fosamax, he said, but it is unclear how they relate to other bisphosphonates. Paul Miller, MD, Medical Director of the Colorado Bone Research, noted that long-term use was not a problem when bisphosphonates first appeared on the market. While "we do not consider many women in the 50's or early 60's bisphosphonates," said Miller, who represented Warner Chilcott, producer Actonel. "We treated worse than women in the 70's and 80's."

In July 2002 the first published results of the initiative in the name of women's health, everything changed, he said. The study showed that most sold brand in postmenopausal estrogen increased stroke risk and the

. In postmenopausal women who were on hormone therapy to protect their bones flooded doctors' offices in search of alternatives, said Miller. Most patients bisphosphonates who testified before the commission on his unusual hip fractures said that they started using drugs in the 50's or 60's. Some women said they were offered drugs, which means that their bone mineral density was lower than usual, but not enough to be classified as osteoporosis. Advisory committee member Clifford Rosen, MD, director of clinical and translational research in the Medical Center of Maine Research Institute in Scarborough, questioned the feasibility of bisphosphonates appointment just for prevention of osteoporosis, rather than treating it. "Prevention of an indication, I think, now again the opposite, including the FDA," said Keho response. "Of course, this is what we are fighting corruption and decisions."