Sunday, November 18, 2007

New Ad for Actos in Wake of Avandia's Revised Safety Warning

On the heels of Avandia's new safety warning addressing a potential increased risk for heart attack (see previous post), Takeda, maker of Actos (pioglitazone), plans to launch a big advertising campaign using the headline:
"If you have type 2 diabetes, Actos has been shown to lower blood sugar without increasing your risk of having a heart attack or stroke."
The FDA reviewed cardiovascular data from Takeda's PROactive study and approved this claim.

Avandia and Actos are the only drugs in the class of diabetes medications known as thiazolidinediones. They work by increasing insulin sensitivity.

Both drugs, however, may worsen heart failure, a condition in which the heart does not adequately pump blood, and are labeled as such. Below is Actos' boxed warning regarding heart failure:
Thiazolidinediones (TZDs), including ACTOS, cause or exacerbate congestive heart failure (CHF) in some patients. After initiation of ACTOS 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 ACTOS must be considered.

ACTOS is not recommended in patients with symptomatic heart failure. Initiation of ACTOS in patients with established NYHA Class III or IV heart failure is contraindicated.

Takeda's press release responding to Avandia's new safety warning:
Re. U.S. Food and Drug Administration Decision Summary