According to new warnings from federal health regulators, the cholesterol drug Trilipix may not reduce the risk of heart attack or stroke, and may actually increase the risk of heart problems among women. Trilipix (fenofibric acid) is an Abbott Laboratories drug approved by the FDA in December 2008. It is supposed to work by lowering “bad” cholesterol and increasing “good” cholesterol. It is often used in combination with cholesterol-lowering drugs like Zocor, known as statins.

Abbott Laboratories, which manufactures the medication, is being required to conduct new clinical trials to measure Trilipix heart effects for patients at high risk of cardiovascular disease, according to the agency.

This came after the FDA analyzed data from a clinical trial known as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The trial compared the safety and efficacy of Trilipix plus Zocor therapy against taking Zocor alone.

The findings of that trial appear to indicate that Trilipix does not decrease the rate of heart attack or stroke on its own, according to the FDA. Also, women appeared to suffer an increased rate of cardiovascular events while on Trilipix.

The FDA is warning patients that the drug has not been shown to lower the risk of heart attack or stroke, and said patients should consult with their primary healthcare provider about the benefits and risks of taking Trilipix.