Pargluva dangers, Public Citizen Warns
-November 22, 2005
According to the consumer rights group Public Citizen, the experimental diabetes drug, Pargluva, can increase the risk of heart failure and death. Despite initial support from regulators, the group says the FDA should not allow Pargluva onto the market. Public Citizen has publicly asked the FDA to delay approving Pargluva (generic: muraglitazar) until, at the very least, a five-year clinical study is conducted to determine the drug’s safety and effectiveness.
Earlier this month, the makers of Pargluva, Bristol-Myers Squibb and Merck & Co, announced they would decide in the coming months whether or not they will continue working on obtaining FDA approval for Pargluva. Back in October 2005, the FDA informed the pharmaceutical companies that more heart safety information was required before the agency would consider approving Pargluva.
Public Citizen urges the FDA to exercise caution before deciding to approve this potentially dangerous diabetes drug. The group points out other, less risky, medications are already available for the treatment of diabetes. The following statements were issued by Public Citizen in a letter to the FDA: “We question why a drug that an FDA medical officer has concluded causes dose-related edema [swelling], weight gain, and congestive heart failure needs to be approved for diabetic patients who are already at an increased risk for cardiovascular adverse effects and who already have multiple drugs available to treat their conditions.”
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