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Diabetes Drug Pargluva Should Not Be Approved, Public Citizen, Clinical Trial Experts Tell FDA

Nov. 21, 2005

Diabetes Drug Pargluva Should Not Be Approved, Public Citizen, Clinical Trial Experts Tell FDA

Drug Known to Cause Death and Congestive Heart Failure

WASHINGTON, D.C. – The drug muraglitazar (Pargluva), which has received an “approvable” letter from the U.S. Food and Drug Administration (FDA), should not be approved for the treatment of diabetes because it increases the risk of death, congestive heart failure and other adverse events and because safer alternatives are available, Public Citizen and two clinical trial experts have told the FDA.

In a letter sent today to Andrew Von Eschenbach, the acting commissioner of the FDA, the authors questioned the benefits of the drug compared to other similar treatments. Public Citizen urged the FDA to not approve the drug until, at the very least, a five-year randomized controlled trial is completed to more thoroughly assess the drug’s risks.

In testimony before an FDA Advisory Committee in September, Public Citizen cited FDA briefing documents that showed an increase in deaths in patients taking Pargluva compared to patients taking another type of diabetes drug or placebo. About half of the deaths were cardiovascular-related. Studies also show an increase in congestive heart failure, weight gain and cancer associated with Pargluva. Despite the evidence, the FDA advisory committee voted to approve the drug. However, the committee lacked a cardiologist and based its approval on the promise of future studies from the drugmaker. FDA, apparently, was not convinced of the drug’s safety, and on October 18 notified the sponsoring companies, Bristol-Myers and Merck, that the drug was “approvable,” pending additional studies.

Two days after that letter, another analysis of the drugmaker’s data was published by highly respected cardiologists at the Cleveland Clinic, Steven Nissen and Eric Topol. This analysis also depended on FDA documents and showed an increased risk of death, heart attack or stroke. Additionally, an accompanying editorial in the Journal of the American Medical Association by Dr. James Brophy of McGill University, a signatory to today’s Public Citizen letter, states, “the meticulous examination   of the current evidence … should focus   serious attention on the potential cardiovascular risks of this   drug.”

“The FDA clearly needs more information about this possibly lethal drug before it gives its stamp of approval,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Relatively safe and effective drug treatments exist for diabetes, and since there is no evidence to demonstrate that Pargluva has any unique benefit over other drugs, there is no basis for approving it before it has cleared additional safety hurdles.”

Public Citizen is also joined in its letter to the FDA by Dr. Curt Furberg, professor of Public Health Sciences at Wake Forest University School of Medicine.

To read the letter, click here.