Washington - The popular heartburn drug Propulsid can cause dangerous irregular heartbeats and even sudden death, the US government said on Monday. The medicine should be used only as a last resort - and only by patients first given heart tests to ensure they are at low risk for the side effect, it warned.
Patients now taking Propulsid should ask their doctors about switching medication, and doctors should not prescribe the drug without first performing an EKG, or electrocardiogram, the Food and Drug Administration said.
Nor should anyone with heart disease or a list of other illnesses use the drug, the FDA said.
The FDA's unusually strong warning comes in the wake of 70 deaths and 200 other reports of irregular heartbeat and other heart rhythm disturbances since Propulsid hit the market in 1993.
Manufacturer Janssen Pharmaceuticals mailed the warning to thousands of physicians on Monday.
The FDA first warned that Propulsid can cause serious heart problems in June 1998, but it continued to receive reports of deaths and hospitalizations.
So the agency took additional steps to make sure Propulsid is used only by patients with severe nighttime heartburn who get no relief from other drugs - and only if they appear at low risk for the cardiac side effects.
The FDA said it was not pulling Propulsid off the market because the drug can help some patients and because the new warnings should make using it safer.
The cardiac risk is relatively small considering an estimated 30 million Propulsid prescriptions have been written since 1993, and most people who suffered the heart problems had clear risk factors, said Dr Florence Houn, FDA's chief of gastrointestinal drugs. That means careful doctors who heed the new warnings should be able to keep Propulsid away from the patients most likely to be hurt, she said.- Sapa-AP