Drug class gets stronger warning of heart risk
Drug class gets stronger warning of heart risk
The FDA will now require manufacturers of all thiazolidinediones (TZDs) to add a stronger "boxed" warning to the label highlighting the risk of heart failure. The change was implemented following an agency review of postmarketing adverse event reports that found cases of significant weight gain and edema, warning signs of heart failure. Healthcare professionals are encouraged to observe patients for excessive rapid weight gain, edema, and shortness of breath after beginning therapy with a TZD. If these signs appear, treatment with a TZD should be reconsidered and alternative treatment options discussed. The new update also added that TZDs should not be used in patients with established NYHA Class III or IV heart failure and is not recommended in patients with symptomatic heart failure. The affected drugs include rosiglitazone (Avandia, GlaxoSmithKline), pioglitazone (Actos, Takeda), rosiglitazone/glimepiride (Avandaryl, GSK), rosiglitazone/metformin (Avandamet, GSK), and pioglitazone/glimepiride (Duetact, Takeda).
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
