"This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet," says the FDA's Mary H. Parks, MD, in a news release. "However, to ensure safe and effective use of this product, tablets containing different doses of [Januvia] and [Zocor] in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking."
Juvisync will be available in several different dosage strengths to accommodate the needs of patients with varying levels of cholesterol and blood sugar.
The FDA says it recently has become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. However, this risk is outweighed by the benefits of the combo pill in reducing heart disease, according to FDA. Prescribing information for Juvisync will educate doctors about this possible side effect.