FDA cites risks of J&J heartburn drug after deaths
By Ransdell Pierson
NEW YORK, Jan 24 (Reuters) - The U.S. Food and Drug Administration said Monday it had issued a warning to doctors about possible dangers of Johnson & Johnson's (NYSE:JNJ - news) treatment for heartburn, Propulsid, following reports of scores of fatalities among users of the blockbuster medication.
The U.S. Food and Drug Administration said it acted after analyzing 270 reports of adverse events, including 70 fatalities, among people who have taken the drug since it was launched in 1993. The agency said about 85 percent of the cases involved patients with identifiable risks.
J&J does not disclose sales of individual drugs. But some analysts have estimated that Propulsid's global 1999 sales approached $1 billion, making it the New Jersey drugmaker's third biggest-selling pharmaceutical.
``Today's actions are prompted by continuing reports of heart rhythm disorders and deaths associated mostly with the use of the drug in people who are either taking certain other medications or who have certain underlying conditions that are known risk factors,' the FDA said.
The FDA said that because of the reports, the medicine's insert label will be changed to require that doctors perform an electrocardiogram and various blood tests prior to prescribing it.
The label change will state that Propulsid should not be used by patients already taking certain types of medicines for allergies, angina, nausea and irregular heart rhythm as well as those taking certain types of antibiotics, anti-depressants, antifungals, anti-psychotics and protease inhibitors against the HIV virus.
J&J said the antidepressants which should not be taken with Propulsid include the entire class of older therapies known as tricyclics, while the forbidden antibiotics include three members of the macrolide family -- including erythromycin.
Moreover, the FDA said it also advised that patients not take Propulsid if they have a history of irregular heartbeat, abnormal electrocardiograms, heart disease, kidney disease, lung disease, low blood levels of potassium, calcium or magnesium, eating disorders, dehydration or persistent vomiting.
Propulsid (cisapride), which was approved by the FDA in tablet form in 1993 and in suspension form in 1995, is sold by J&J's Janssen Pharmaceutica unit.
Jannsen spokesman Greg Panico declined to speculate how seriously Propulsid's sales would be hurt by the FDA warning letter, the label changes and the newly mandated medical tests.
``Our drug is safe, when used appropriately. But after any label change there is some dropoff in a drug's sales,' he said. Panico added that the 270 adverse event reports stretched out over a 7-year period, during which time he said 30 million prescriptions for the drug had been written in the United States.
Propulsid is a treatment severe night-time heartburn for patients with gastroesophageal reflux disease (GERD) who do not adequately respond to other therapies.
In patients with GERD, acid and stomach contents back up into the esophagus, causing heartburn and other symptoms. Persistent heartburn over a long period can lead to esophageal cancer.
Shares of J&J fell 6-1/8 to 83-11/16, or 7.3 percent, amid a sharp decline in the U.S. pharmaceutical sector and broad decline in U.S. markets.
JNJ getting beat up pretty bad. Any comments?
In faith I mailed a check into my JNJ DRP.
Happy investing, Ted |
