IBS Drug Zelnorm Taken Off U.S. Market
FDA: Voluntary Withdrawal Due to Risk of Heart Attack, Stroke, Chest Pain
March 30, 2007 -- A popular drug for irritable bowel syndrome and
constipation was pulled from the U.S. market Friday amid new evidence that it
raises the risk of heart attacks and strokes.
Novartis, the manufacturer of Zelnorm, confirmed that Food and Drug
Administration officials asked for the drug’s withdrawal.
Agency officials said they based their decision on a Swiss government
analysis of 29 Zelnorm studies that showed a higher chance of cardiovascular
events, such as heart attack, stroke, or severe heart-related chest pain in
patients treated with Zelnorm compared with those given a placebo.
The analysis turned up 13 cases of heart attack, stroke, or angina (chest
pain related to heart disease) in about 11,600 patients who took the drug. One
of the 13 died, the agency said. This was compared with just one nonfatal event
in more than 7,000 patients who took the placebo.
John Jenkins, MD, head of the FDA’s Office of New Drugs, described the
overall number of dangerous events as “quite small.” But he said the rate of
cardiovascular events -- about 10 times higher in patients taking Zelnorm --
raised alerts about the drug.
“Based on our review of the data we believed that the risk vs. benefit
profile for Zelnorm was no longer favorable,” Jenkins told reporters on a
He said patients taking Zelnorm should speak immediately to their
Special Access to Zelnorm
Though the drug will no longer be widely available, patients who have no
other treatment options could still get access to the drug. The FDA said it is
likely to allow Novartis to continue selling Zelnorm to patients if their
doctors say they have disease that does not respond to any other treatment and
if the benefits of treatment with Zelnorm outweigh the risks of serious side
effects. Drug access would be done through a special program.
The FDA says it has told Novartis that it's willing to consider limited
reintroduction of Zelnorm at a later date if a population of patients can be
identified in whom the benefits of the drug outweigh the risks.
However, before the FDA makes a decision about limited reintroduction, any
proposed plan would be discussed at a public advisory committee
In a statement, Novartis maintained that no evidence proves that Zelnorm
caused heart attack or strokes and that event rates were not significantly
different from those in the general population. But the company confirmed it
would pull Zelnorm from the market.
“Novartis has suspended the marketing, sales, and distribution of Zelnorm in
response to the FDA's request,” the statement read.
Novartis is a WebMD sponsor.
Zelnorm was approved for short-term treatment of women with irritable bowel
syndrome (IBS) with constipation and for patients younger than 65 years with
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