Studies Novartis Drug For Cardiovascular Risk
regulators are studying a Novartis Parkinson's disease treatment to determine
if it contributes to an increased risk of heart attacks or strokes.
and Drug Administration is examining clinical trial data related to the
drug Stalevo, but said patients should not stop taking the drug unless directed
to do so by a health care professional.
shows a small increased risk, the FDA said, but it has not concluded that
Stalevo is to blame.
factors have made the evaluation difficult, regulators say. For instance,
the trials were not designed to evaluate cardiovascular safety, and most
of the patients had pre-existing risk factors for cardiovascular disease.
should also be noted that cardiovascular events are not uncommon in people
with Parkinson's disease in the age range studied in these trials,"
the FDA said in a statement Friday.