FDA finds no links between bone-building drugs and heart problems.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. issued an early communication on Oct. 1 about the ongoing review of new safety data regarding the association of atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. with the use of bisphosphonates. The agency said it had found no statistically significant evidence to confirm a link between popular bone-building drugs and irregular heart rhythms in older women, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. an Associated Press Associated Press: see news agency. Associated Press (AP) Cooperative news agency, the oldest and largest in the U.S. and long the largest in the world. (AP) report. FDA recommended patients continue using the drugs as normal. While FDA said it could take another year to complete its safety review, the agency has not found a causal relationship between the osteoporosis treatments and heart problems. FDA began reviewing the drugs' safety in May, after medical journal studies found women using Novartis' Reclast and Merck's Fosamax had higher rates of irregular heart beats than women on placebo, the AP reported. While the findings were not statistically significant, they raised concerns among doctors and patients because heart irregularities can sometimes cause stroke. In a review of Reclast specifically, FDA said women taking the drug did not develop heart spasms until more than a month after taking it, suggesting the drug did not trigger the problems. Also, in a subset of patients monitored by electrocardiogram electrocardiogram /elec·tro·car·dio·gram/ (-kahr´de-o-gram?) a graphic tracing of the variations in electrical potential caused by the excitation of the heart muscle and detected at the body surface. up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo. The injectable drug is given to patients once a year in a 15-minute infusion. FDA approved the drug in 2002 as a treatment for cancer patients and expanded it for use in osteoporosis in August. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget's disease Paget's disease n. 1. A disease, occurring chiefly in old age, in which the bones become enlarged and weakened, often resulting in fracture or deformation. Also called osteitis deformans. 2. of the bone, treat bone metastases bone metastases Oncology Cancer that has spread from a primary tumor to the bone , and lower elevated levels of blood calcium blood calcium, n the level of calcium in the blood plasma, generally regulated by parathyroid gland activity in conjunction with the degree of calcium ingestion, absorption, use, and excretion. Normal value is 8.5 to 11.5 mg/100 ml of blood serum. in patients with cancer. Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that health care providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. Read the complete MedWatch 2007 Safety Summary including a link to FDA Early Communication at:: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Bisphosphonates |
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