FDA Issues Warning for Heartburn Drug PROPULSID
by Clark Hansen, N.M.D.

January 25, 2000 – According to the FDA, patients now taking Propulsid should ask their doctors about switching medication. The FDA’s unusually strong warning comes in the wake of 70 deaths and 200 other reports of adverse reactions since Propulsid hit the market in 1993.

The popular heartburn drug Propulsid can cause dangerous irregular heartbeats and other heart-rhythm disturbances and even sudden death, the government said 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.

The FDA warned that Propulsid should not be used by anyone taking certain antibiotics, antidepressants, antifungals, protease inhibitors, antiarrhythmics, or various other drugs that taken in combination with Propulsid can induce adverse events including death. The new warning list includes 20 drugs and one food -- grapefruit juice, which increases the bioavailability of Propulsid -- and then states, "The preceding list is not comprehensive." In other words, taking this drug is like playing Russian Roulette.

The FDA warning was issued in conjunction with a "Dear Doctor" letter required by the FDA of the drug’s manufacturer. The low keyed letter from Janssen Pharmaceutica, of Titusville, NJ, mailed to thousands of doctors, seemed to down play the magnitude of the findings, suggesting that these adverse events occurred mainly in patients with known risk factors and could therefore be avoided by more careful prescribing practices by physicians. The letter stated,

"Dear Doctor, Janssen Pharmaceutica would like to inform you of important changes made in the PROPULSID (cisapride) labeling. We wish to draw you attention to the Boxed Warning, Drug Interactions and Dosage and Administration sections that contain the essential changes."

Hopefully, every doctor on the got the letter and actually perceived the gravity of the revised Box: "Warning: Serious cardiac arrhythmias... have been reported in patients taking PROPULSID. From July 1993 through May 1999, more than 270 such cases have been spontaneously reported, including 70 fatalities."

How many people have to die for a drug? By June 26, 1998, the FDA had already received reports of 38 deaths in the U.S. associated with Propulsid use. As a matter of course they sent notice to doctors adding additional warnings to the label. "Nevertheless, they stated, "FDA cannot directly link reported deaths to the drug.

Propulsid is a drug used for nighttime heartburn in patients with gastroesophageal reflux disease (GERD). It was used on adults as well as infants until the June 1998 report of associated deaths in infants was released. In its FDA required "Dear Doctor" letter, Janssen Pharmaceutica tried to cover its liability, stating "Although causality has not been established, serious adverse events, including death, have been reported in infants and children treated with cisapride (Propulsid)."

"Several pediatric deaths were due to cardiovascular events (third degree heart block and ventricular tachycardia). Pediatric deaths have been associated with seizures and there has been at least one case of "sudden unexplained death" in a 3-month-old infant."

The explanation seems clear to me. Propulsid is a dangerous drug and we need to remove it from the market and replace it with a safer natural alternative.

The FDA, on the other hand, said it is not pulling Propulsid off the market because the drug can help some patients and because the new warnings should make using it safer.

The FDA’s chief of gastrointestinal drugs, Florence Houn, said 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. Therefore, the FDA will gather heartburn and cardiac experts for a special meeting April 12 to determine whether the new Propulsid warnings are adequate. Don’t wait for the FDA! Ban this drug from your body.

SOURCE: MedWatch (HF-2) FDA, January 24, 2000, www.fda.gov/medwatch/safety/2000/propul.htm.