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The thiazolidinedione agent rosiglitazone now can be prescribed without complying with a Risk Evaluation and Mitigation Strategy (REMS), according to the Food and Drug Administration.
It’s been a long, strange trip for the drug that was approved in 1999 to lower blood sugar in patients with type 2 diabetes and is sold under a number of brands, including Avandia, Avandamet, and Avandaryl, as well as generics. Over the first years it was marketed, there were reports that its use was associated with an increased risk for heart failure and myocardial infarctions.
In May 2007, the FDA issued an alert that use of rosiglitazone was associated with ischemic cardiovascular events, which eventually led the agency to add a black box warning to the drug’s label in August 2007 that its use was associated with heart failure in patients with type 2 diabetes. In November 2007 the FDA extended the warning to cover an increased risk for myocardial infarction, based on “a meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”
In May 2011, the FDA issued a requirement that physicians who prescribed rosiglitazone participate in a REMS program. But by November 2013 the agency had withdrawn its restrictions on prescription of the drug to patients with diabetes.
Today’s action may be the final step in returning the drug to use. However, the number of new drugs that have been approved for management of type 2 diabetes in the years since rosiglitazone first appeared problematic may make this FDA action irrelevant.
The thiazolidinedione agent rosiglitazone now can be prescribed without complying with a Risk Evaluation and Mitigation Strategy (REMS), according to the Food and Drug Administration.
It’s been a long, strange trip for the drug that was approved in 1999 to lower blood sugar in patients with type 2 diabetes and is sold under a number of brands, including Avandia, Avandamet, and Avandaryl, as well as generics. Over the first years it was marketed, there were reports that its use was associated with an increased risk for heart failure and myocardial infarctions.
In May 2007, the FDA issued an alert that use of rosiglitazone was associated with ischemic cardiovascular events, which eventually led the agency to add a black box warning to the drug’s label in August 2007 that its use was associated with heart failure in patients with type 2 diabetes. In November 2007 the FDA extended the warning to cover an increased risk for myocardial infarction, based on “a meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”
In May 2011, the FDA issued a requirement that physicians who prescribed rosiglitazone participate in a REMS program. But by November 2013 the agency had withdrawn its restrictions on prescription of the drug to patients with diabetes.
Today’s action may be the final step in returning the drug to use. However, the number of new drugs that have been approved for management of type 2 diabetes in the years since rosiglitazone first appeared problematic may make this FDA action irrelevant.
The thiazolidinedione agent rosiglitazone now can be prescribed without complying with a Risk Evaluation and Mitigation Strategy (REMS), according to the Food and Drug Administration.
It’s been a long, strange trip for the drug that was approved in 1999 to lower blood sugar in patients with type 2 diabetes and is sold under a number of brands, including Avandia, Avandamet, and Avandaryl, as well as generics. Over the first years it was marketed, there were reports that its use was associated with an increased risk for heart failure and myocardial infarctions.
In May 2007, the FDA issued an alert that use of rosiglitazone was associated with ischemic cardiovascular events, which eventually led the agency to add a black box warning to the drug’s label in August 2007 that its use was associated with heart failure in patients with type 2 diabetes. In November 2007 the FDA extended the warning to cover an increased risk for myocardial infarction, based on “a meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”
In May 2011, the FDA issued a requirement that physicians who prescribed rosiglitazone participate in a REMS program. But by November 2013 the agency had withdrawn its restrictions on prescription of the drug to patients with diabetes.
Today’s action may be the final step in returning the drug to use. However, the number of new drugs that have been approved for management of type 2 diabetes in the years since rosiglitazone first appeared problematic may make this FDA action irrelevant.
FROM THE FOOD AND DRUG ADMINISTRATION
