The Food and Drug Administration has issued a stern warning that the popular heartburn drug Propulsid can cause dangerous irregular heartbeats and even sudden death, and should be used only as a last resort in patients with the worst cases of gastroesophageal reflux disease.
According to the warning, patients now taking Propulsid should ask their doctors about switching medication, and doctors should not prescribe the drug without first doing an electrocardiogram to rule out underlying cardiac abnormalities.
When Not to Use It
The FDA also included in its warning cautions about taking Propulsid with certain other medications, such as the class of protease inhibitors used to treat AIDS, and a new list of medical conditions whose sufferers should avoid Propulsid, such as severe dehydration.
The FDA recommends that elderly people be especially cautious about using the drug, since many use multiple medications or have existing medical conditions placing them at high risk for problems with Propulsid.
70 Deaths in Seven Years
The warning comes in the wake of 70 deaths and 200 other reports of irregular heartbeat and other rhythm disturbances since Propulsid hit the market in 1993. An estimated 30 million prescriptions have been written so far.
Letters sent out today by the drug’s manufacturer, Johnson & Johnson Pharmaceuticals, advise doctors of the new warnings.
For some, letters are not enough. “People have died needlessly from taking Propulsid and its being sold without strong enough warnings,” said Sidney Wolfe, director of the consumer advocacy group Public Citizen. “This drug should be taken off the market and not used unless patients and doctors know of all the contraindications.”
First Warning Last Year
The FDA first warned last year that Propulsid can cause serious heart problems. Since that time, the drug has carried a so-called “black box” warning doctors of its potential to cause dangerous cardiac arrhythmias.
The problem mainly involves QT prolongation, a defect in the conduction of electrical current through the heart that can, in rare cases, lead to problems such as ventricular fibrillation and sometimes complete heart block leading to cardiac arrest.
Most patients who experienced problems with Propulsid had underlying cardiac disorders that may have predisposed them to arrhythmias. Many also took other medications known to increase blood levels of Propulsid by inhibiting the liver enzyme that breaks down the drug.
Drug ‘Less Attractive’
“There’s and increasing number of drugs with which Propulsid interacts which create disturbances in the heart’s rhythm,” said Peter A. Banks, MD, Director of Clinical Gastroenterology at the Brigham and Women’s Hospital in Boston. “I’ve moved away from using the drug as I read reports of rhythm problems. It makes the drug less and less attractive.”
The FDA’s warning covers Propulsid’s approved use in the setting of gastroesophageal reflux disease, commonly known as heartburn, but does not mention the drug’s use for other conditions, especially gastrointestinal motility disorders caused by diseases such as diabetes and scleroderma, though such patients likely account for only a small number the drug’s total prescriptions.
“There are countless medications to treat reflux so this really isn’t going to have a big impact on clinical practice,” said Lawrence Cohen, M.D., associate professor of gastroenterology at Mount Sinai Hospital, New York. Drugs to reduce stomach acid “such as proton pump inhibitors or H-2 blockers are really first-line therapies and Propulsid is added only after those treatments fail. Most gastroenterologists will now turn to drugs that reduce acid,” he said.
One stock analyst who follows Johnson & Johnson said Wall Street was already expecting sales of Propulsid to decline as newer, more effective agents gain popularity. “If it was withdrawn outright, then it would have earnings consequences but if sales sort of drift downhill, it probably isn’t going to have an impact on J&J’s earnings,” he said.
What to Watch Out For
If you or someone you know is taking Propulsid, here are details from the FDA’s new warnings:
Do not prescribe Propulsid to anyone with heart disease, including valvular disease, or who has ever had an irregular heartbeat, abnormal EKG or QT prolongation.
Do not prescribe Propulsid to people with kidney disease; lung disease; low blood levels of the electrolytes potassium, calcium or magnesium; an eating disorder; dehydration or prolonged vomiting.
Never take Propulsid while using a list of other medications, including antibiotics like erythromycin; antifungals like ketoconazole; AIDS-fighting protease inhibitors; drugs for irregular heartbeat; certain antidepressants and antipsychotics such as Elavil or Serzone. Also do not take with grapefruit juice.
In addition to an EKG, patients being considered for Propulsid should undergo blood tests to check electrolyte levels.
The FDA will gather heartburn and cardiac experts for a special meeting April 12 to determine whether the new Propulsid warnings are adequate.
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