| dailymed-drugs:2866 | dailymed-instance:boxedWarn... | WARNING: CONGESTIVE HEART FAILURE
AND MYOCARDIAL ISCHEMIA: ���Thiazolidinediones, including rosiglitazone, cause or exacerbate
congestive heart failure in some patients [see Warnings and
Precautions (5.1)]. After initiation of AVANDIA, and after dose increases, observe
patients carefully for signs and symptoms of heart failure (including
excessive, rapid weight gain, dyspnea, and/or edema). If these signs
and symptoms develop, the heart failure should be managed according
to current standards of care. Furthermore, discontinuation or dose
reduction of AVANDIA must be considered. ���AVANDIA is not recommended in patients with symptomatic
heart failure. Initiation of AVANDIA in patients with established
NYHA Class III or IV heart failure is contraindicated. [See Contraindications
(4) and Warnings and Precautions (5.1).] ���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 total 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. [See Warnings
and Precautions (5.2).] | lld:dailymed |
