In response to the major furore over Avandia and its alleged effect on heart attack prevalence, Takeda North America have announced that they are revising warnings on their medication for type 2 diabetics, Actos.
In response to a request from the Food and Drug Administration that a boxed warning should be included on every label, Takeda are making the adjustments. The warning highlights the risk of congestive heart failure for patients taking the drug.
Robert Spanheimer, MD, the senior medical director of the Diabetes and Metabolism arm of Takeda, reportedly commented: “By giving the CHF guidance more prominence in the ACTOS label, we hope to ensure that this information is being attended to by treating physicians to optimize patient care. Takeda remains confident in the safety and efficacy of ACTOS when used according to its label, and with this revision, we can heighten patient and physician awareness of an already know, but serious side effect.”
Takeda have been clear in emphasising that physician education and patient monitoring are the key to successful diabetes drug management .
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