Warning on diabetes drug could be a replay of Vioxx
AMNews: June 11, 2007. Warning on diabetes drug could be a replay of Vioxx ... American Medical News
Warning on diabetes drug could be a replay of Vioxx
Congress is urged to take steps to help avoid future drug safety issues as it moves toward passage of an FDA bill.
By Susan J. Landers, AMNews staff. June 11, 2007.
Washington -- A New England Journal of Medicine article prompted the Food and Drug Administration to issue a safety alert for Avandia, or rosiglitazone, a drug used by several million patients to treat type 2 diabetes. Safety data from clinical trials indicated that the drug poses a possible increase in the risk of heart attacks, according to the article, which was published online May 21.
Not only did the article prompt the need for physicians to look more closely at who is prescribed the drug, but it also raised alarms anew over the FDA's ability to carry out effectively its role as safety monitor for the nation's drug supply.
The warning was posted by Steven Nissen, MD, chair of the Cleveland Clinic's Dept. of Cardiovascular Medicine, who analyzed 42 trials of rosiglitazone, which was approved by the FDA in 1999. Dr. Nissen and Cleveland Clinic statistician Kathy Wolski, MPH, found that the use of the drug was associated with an increased risk of heart attack and cardiovascular death -- by 43% and 64% respectively -- compared with placebo.
The findings represent a particular health concern, Dr. Nissen said, because more than 65% of deaths in diabetic patients are attributed to heart disease.[...]
Copyright 2007 American Medical Association. All rights reserved.
RELATED CONTENT You may also be interested in: Drugs have risks, but so does life, study notes May 28 Shoring up the drug safety system Editorial Feb. 26 FDA responds to drug safety blueprint Feb. 26 Institute of Medicine report urges major changes at Food and Drug Administration Oct. 16, 2006
Warning on diabetes drug could be a replay of Vioxx
Congress is urged to take steps to help avoid future drug safety issues as it moves toward passage of an FDA bill.
By Susan J. Landers, AMNews staff. June 11, 2007.
Washington -- A New England Journal of Medicine article prompted the Food and Drug Administration to issue a safety alert for Avandia, or rosiglitazone, a drug used by several million patients to treat type 2 diabetes. Safety data from clinical trials indicated that the drug poses a possible increase in the risk of heart attacks, according to the article, which was published online May 21.
Not only did the article prompt the need for physicians to look more closely at who is prescribed the drug, but it also raised alarms anew over the FDA's ability to carry out effectively its role as safety monitor for the nation's drug supply.
The warning was posted by Steven Nissen, MD, chair of the Cleveland Clinic's Dept. of Cardiovascular Medicine, who analyzed 42 trials of rosiglitazone, which was approved by the FDA in 1999. Dr. Nissen and Cleveland Clinic statistician Kathy Wolski, MPH, found that the use of the drug was associated with an increased risk of heart attack and cardiovascular death -- by 43% and 64% respectively -- compared with placebo.
The findings represent a particular health concern, Dr. Nissen said, because more than 65% of deaths in diabetic patients are attributed to heart disease.[...]
Copyright 2007 American Medical Association. All rights reserved.
RELATED CONTENT You may also be interested in: Drugs have risks, but so does life, study notes May 28 Shoring up the drug safety system Editorial Feb. 26 FDA responds to drug safety blueprint Feb. 26 Institute of Medicine report urges major changes at Food and Drug Administration Oct. 16, 2006
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