Takeda’s Actos to include black box heart warning

“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, senior medical director of diabetes and metabolism at 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,” Dr Spanheimer continued.

The Actos label has always contained information that the thiazolidinedione class, which the drug belongs to, can cause fluid retention, which may lead to or exacerbate CHF. Takeda added that it has consistently emphasized the importance of physician education and patient monitoring involved in the use of the diabetes treatment.

The company said results from the recent PROactive Study of Actos, known generically as pioglitazone HCl, had shown although that the incidence of CHF was higher for Actos-treated patients compared to those treated with a placebo (5.7% vs. 4.1%), there was no increase in the incidence of death subsequent to a report of CHF (1.5% vs. 1.4%, respectively).

CHF is a known complication for people with type 2 diabetes, in which inadequate pumping from the heart causes accumulation of fluid throughout the body including the lungs. The heart continues to work, but inefficiently.

The black box warning on heart risks, the strongest possible warning on US drug labelling, follows concerns over cardiovascular problems linked to certain diabetes drugs. The FDA has reportedly also asked GlaxoSmithKline to add a black box warning to its diabetes treatment Avandia, which has recently generated headlines after being linked to an increased risk of death from cardiovascular events.