The FDA Talk Paper says Limit use of COX2
FDA Issues Public Health Advisory Recommending Limited Use of Cox-2
Inhibitors
Agency Requires Evaluation of Prevention Studies Involving Cox-2
Selective Agents
The Food and Drug Administration (FDA) today issued a Public Health
Advisory summarizing the agency's recent recommendations concerning the
use of non-steroidal anti-inflammatory drug products (NSAIDs),
including those known as COX-2 selective agents. The public health
advisory is an interim measure, pending further review of data that
continue to be collected.
In addition, FDA today announced that it is requiring evaluation of all
prevention studies that involve the Cox-2 selective agents Celebrex
(celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions
are implemented in the studies and that local Institutional Review
Boards reevaluate them in light of the new evidence that these drugs
may increase the risk of heart attack and stroke. A prevention trial is
one in which healthy people are given medicine to prevent a disease or
condition (such as colon polyps or Alzheimer's disease).
more story: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01336.html
Ski Sullivan
yoursurgery.net
Inhibitors
Agency Requires Evaluation of Prevention Studies Involving Cox-2
Selective Agents
The Food and Drug Administration (FDA) today issued a Public Health
Advisory summarizing the agency's recent recommendations concerning the
use of non-steroidal anti-inflammatory drug products (NSAIDs),
including those known as COX-2 selective agents. The public health
advisory is an interim measure, pending further review of data that
continue to be collected.
In addition, FDA today announced that it is requiring evaluation of all
prevention studies that involve the Cox-2 selective agents Celebrex
(celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions
are implemented in the studies and that local Institutional Review
Boards reevaluate them in light of the new evidence that these drugs
may increase the risk of heart attack and stroke. A prevention trial is
one in which healthy people are given medicine to prevent a disease or
condition (such as colon polyps or Alzheimer's disease).
more story: http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01336.html
Ski Sullivan
yoursurgery.net
