Adverse Event Reporting News - Data about Zetia risks was not fully revealed by Merck and Schering-Plough, evidence suggests
Merck and Schering-Plough have conducted several studies of their popular cholesterol medicine Zetia that raise questions about its risks to the liver, but the companies have never published those results, according to a “New York Times” article of Dec. 21.
Partial results of the studies, alluded to in documents on FDA’s website raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins.
Most of the millions of people who use Zetia take it along with a statin such as Lipitor, Crestor or Zocor.
Related Results
ZetiaZetia tabletsZetia, with fenofibrate, approvedVytorin and Zetia fail in heart studyZetia, Vytorin come under fire
The discovery of the unpublished research comes as Merck and Schering are already under criticism for not yet releasing data from an important Zetia study, called Enhance, that they completed early last year.
The Enhance data may also contain important information about Zetia’s liver risks. At least some patients were dropped from the Enhance study after testing revealed that they had elevated liver enzymes, a Schering-Plough spokesman confirmed in December.
But a full report on that trial, including the number of patients who had liver problems, will not be available until March.
Doctors say that by failing to disclose promptly all their research, Merck and Schering-Plough may be leaving the public with a misleadingly favorable view of Zetia’s safety and benefits.
“You don’t want to have data missing,” said Bruce Psaty, M.D., a professor of medicine and epidemiology at the University of Washington. “When there have been adverse effects, when the benefits don’t look impressive, those are the trials that historically don’t make it to press.”
A Schering executive, when asked by a reporter about the unpublished studies, confirmed their existence. But the executive, Robert Spiegel, M.D., said the companies had not considered the studies scientifically important enough to publish their findings. Some may eventually be published, he said.
“We’re pretty comfortable that people don’t have trouble tolerating Zetia,” said Spiegel, the chief medical officer of the Schering-Plough Research Institute.
Schering also stated that FDA had reviewed the data from the unpublished studies and had approved Zetia for use alongside statins. But experts on drug safety say that the agency has been slow to issue warnings about many widely used drugs that have turned out to carry serious risks, including the painkiller Vioxx, the diabetes medicine Avandia and the anti-psychotic drug Zyprexa.
COPYRIGHT 2008 Washington Information Source, Inc.
COPYRIGHT 2008 Gale, Cengage Learning
