I just read this on Heather's Newletter:
Zelnorm Warning Issued by FDA
The Food and Drug Administration (FDA) announced the addition of serious new risk information to the health professional labeling for Zelnorm. The specific revisions include:
A new warning about the serious consequences of diarrhea associated with the medication.
A new precaution about ischemic colitis and other forms of intestinal ischemia (reduced blood flow to the intestines).
The new warning states: "Serious consequences of diarrhea, including hypovolemia, hypotension and syncope have been reported in the clinical studies and during marketed use of Zelnorm. In some cases, these complications have required hospitalization for rehydration. Zelnorm should be discontinued immediately in patients who develop hypotension or syncope. Zelnorm should not be initiated in patients who are currently experiencing or frequently experience diarrhea."
"The FDA currently has 21 reports of diarrhea so severe that it caused such complications as low blood pressure and fainting. Sixteen patients required hospitalization," said the FDA's Dr. Robert Justice.
"Since Zelnorm went on sale in 2002, the FDA has received 20 reports of ischemic colitis, plus three reports of a similar intestinal problem," Justice said. "Fourteen patients were hospitalized. Four died, although they had numerous other serious medical conditions."
Consumer watchdog Sidney Wolfe said Zelnorm is too dangerous to stay on the market and only slightly more effective than a placebo. He had urged the FDA not to approve the drug in the first place. "If a drug is actually more dangerous than a placebo and not much more effective, it is a very bad trade-off," Wolfe, head of Public Citizen's Health Research Group, said in an interview.
Under the post marketing experience heading in the adverse reactions section, the labeling now states: "Voluntary reports of adverse events occurring with the use of Zelnorm include the following: ischemic colitis, mesenteric ischemia, gangrenous bowel, rectal bleeding, syncope, suspected sphincter of Oddi spasm, bile duct stone, and cholecystitis with elevated transaminases. Because these cases are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. No causal relationship between these events and Zelnorm use has been established. Hypokalemia secondary to diarrhea has also been reported."
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