Actos label updated to advise against use in pediatric patients with type 2 diabetes

actos pioglitazone hydrochloride Actos label updated to advise against use in pediatric patients with type 2 diabetes The type 2 diabetes drug Actos is not recommended for children or adolescents because of potentially dangerous side effects including fluid retention and congestive heart failure, fractures and urinary bladder tumors, according to an update to the drug’s safety label.

Actos, known generically as pioglitazone, is an oral diabetes medicine that helps control blood sugar levels. It is approved for use in adults with type 2 diabetes, a chronic condition often associated with obesity and a sedentary lifestyle. The condition was once known as “adult onset diabetes,” however, with increasing childhood obesity, more children and adolescents are being diagnosed with the disease.

Type 2 diabetes occurs when the body does not produce enough insulin to regulate blood sugar levels. It can lead to serious health problems including heart disease, kidney disease, blindness, and dementia. Most patients require medication to keep their blood sugar levels in check, however many of these drugs carry serious side effects, and pediatric patients can be more susceptible to the risks. This creates challenges in treating young people with the disease.

Actos is not recommended for patients with congestive heart failure or heart disease, fluid retention, a history of bladder cancer, a history of heart attack or stroke, or liver disease. The drug has also been linked to bladder cancer, especially if used long term. The seriousness of these side effects have prompted the Food and Drug Administration (FDA) to require that Actos update its safety label to alert physicians that the drug is not approved in pediatric patients because of the harm that has been seen in adults who have used the drug.

Source: FDA