Lani
10-02-2007, 11:07 PM
U.S. Reviews Bisphosphonates' Effect on Heart
WASHINGTON (Reuters) Oct 02 - The U.S. Food and Drug Administration said on Monday it would study the bisphosphonate class of osteoporosis drugs after two reports in the New England Journal of Medicine finding increased rates of serious atrial fibrillation (AF) in patients who took either Merck's Fosamax or Novartis' Reclast.
"Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time," the FDA said in a statement.
The article described increased rates of serious AF that were life-threatening, resulting in hospitalization or disability, the FDA said.
The FDA alert is part of a broader effort to notify the public earlier in the process when the agency reviews potential safety problems in drugs. It follows intense criticism of the FDA after Merck's painkiller Vioxx was pulled from the market in 2004 for links to heart attacks.
The FDA said it was seeking additional data for an in-depth review of the issue with the entire class of drugs. The review may take up to 12 months, the agency said.
WASHINGTON (Reuters) Oct 02 - The U.S. Food and Drug Administration said on Monday it would study the bisphosphonate class of osteoporosis drugs after two reports in the New England Journal of Medicine finding increased rates of serious atrial fibrillation (AF) in patients who took either Merck's Fosamax or Novartis' Reclast.
"Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time," the FDA said in a statement.
The article described increased rates of serious AF that were life-threatening, resulting in hospitalization or disability, the FDA said.
The FDA alert is part of a broader effort to notify the public earlier in the process when the agency reviews potential safety problems in drugs. It follows intense criticism of the FDA after Merck's painkiller Vioxx was pulled from the market in 2004 for links to heart attacks.
The FDA said it was seeking additional data for an in-depth review of the issue with the entire class of drugs. The review may take up to 12 months, the agency said.