Takeda Pharmaceuticals North America, Inc. (TPNA) announced that the company will revise warnings related to congestive heart failure (CHF) in the prescribing label of its type 2 diabetes medication ACTOS(R) (pioglitazone HCl).
Takeda is working in conjunction with a request from the U.S. Food and Drug Administration (FDA) that a Boxed Warning be added to the label. The new Boxed Warning will heighten awareness of the risk of CHF.
“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,” said Robert Spanheimer, M.D., senior medical director, Diabetes and Metabolism, Takeda Pharmaceuticals North America. “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 known, but serious side effect.”
The ACTOS label has always contained information that the thiazolidinedione (TZD) class can cause fluid retention, which may lead to or exacerbate CHF, and Takeda has consistently emphasized the importance of physician education and patient monitoring involved in the use of ACTOS. Through its global system of surveillance, adverse event reports involving patients taking ACTOS are reviewed and reported to the FDA on an ongoing basis.