(RxWiki News) The US Food and Drug Administration (FDA) has approved label changes for a common diabetes medication.
These new label changes are for sitagliptin-containing medications, which include the following:
- Januvia (sitagliptin)
- Janumet (sitagliptin and metformin hydrochloride)
- Janumet XR (sitagliptin and metformin hydrochloride extended-release)
These new label changes state that these drugs are not proven to help control blood sugar levels in children with type 2 diabetes (ages 10 to 17 years old).
These medications are, however, approved in combination with diet and exercise to help with blood sugar control in adults with type 2 diabetes (18 and older).
Note that this drug does not cure diabetes but helps to lower high blood sugar.
Sitagliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which work to increase the levels of certain natural substances that lower blood sugar in the body.
These new labeling changes are supported by the results of three clinical studies, which showed that there was no significant difference in the lowering of HbA1c of the children who were given sitagliptin when compared to children who were given the placebo.
Common side effects of sitagliptin seen in children included colds and upper respiratory tract infections.
Speak with your child's pediatrician or endocrinologist to discuss any questions you have about diabetes care.