FDA Issues Warning on Heartburn Drug Propulsid

The popular heartburn drug Propulsid can cause dangerous irregular heartbeats and even sudden death, the government said Monday, adding that 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.

The Food and Drug Administration said patients taking Propulsid should ask their doctors about switching medication, and doctors should not prescribe the drug without first performing an EKG, or electrocardiogram.

Anyone with a heart disease should not use the drug, the agency added.

The unusually strong warning comes after 70 deaths and 200 other reports of irregular heartbeat and other heart rhythm disturbances since Propulsid hit the market in 1993.

Manufacturer Johnson & Johnson mailed the warning to thousands of physicians 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 Monday, 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 decided not to pull 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, and since most people who suffered the heart problems had clear risk factors, said Dr. Florence Houn, the FDA’s chief of gastrointestinal drugs.

That means careful doctors who heed the warnings should be able to keep Propulsid away from the patients most likely to be hurt, she said.

But an expert on drug-induced irregular heartbeats said it will be difficult for the gastrointestinal specialists who must prescribe Propulsid to comply.

“FDA warnings have not been as successful as we would like in being translated into care,” said Dr. Raymond Woosley, a pharmacologist at Georgetown University Medical Center.

“This one will be especially difficult because of the fact that many physicians don’t have an EKG” machine in their offices.

The FDA will gather experts on heartburn and the heart for a special meeting April 12 to determine whether the new Propulsid warnings are adequate.