Nothing new really other than that they are rehashing the story:
Wednesday January 20 12:24 AM ET
Warner-Lambert Drug Linked To Deaths On FDA Agenda
MORRIS PLAINS, N.J. (Reuters) - Warner-Lambert Co. (NYSE:WLA - news) said on Friday a Food and Drug Administration panel will review the safety and efficacy data of the company's Rezulin diabetes treatment, which has been linked to 26 deaths.
Rezulin, which has been used by 1.4 million U.S. patients, has been the subject of critical ABC and CBS television reports since 26 people died and four people needed liver transplants through November 1998 after taking the oral treatment, company spokeswoman Carol Goodrich said.
The March 26 review before the agency's Endocrinologic and Metabolic Drugs Advisory Committee was scheduled following news coverage claiming the FDA did not review the drug thoroughly before its approval in January 1997.
Warner-Lambert has vigorously denied the allegations and said it welcomed the opportunity to defend its second-best-selling drug at the advisory panel meeting.
It said the meeting would offer a chance ''for a rational review of Rezulin post-marketing safety and efficacy data in a scientific forum, particularly in light of recent media reports that have contained inaccurate claims and misstatements based on anecdotal case reports.''
''We are confident that when all of the relevant scientific data are reviewed in their entirety, the advisory committee will agree that the benefits of Rezulin therapy for type 2 diabetes patients continue to far outweigh the risks,'' senior company official Anthony Wild said in a statement.
Type 2 diabetes, also called adult-onset diabetes, is far more common but less serious than the type 1 form of the disease which begins in childhood.
The FDA panel will also review the Morris Plains, N.J.-based drugmaker's supplemental new drug application for combination therapy with the Bristol-Myers Squibb Co. (NYSE:BMY - news) diabetes drug Glucophage (metformin) as well as with sulfonylureas and Glucophage.
Warner-Lambert has chosen to amend a 400-patient study that is designed to evaluate the potential of Rezulin in reducing insulin resistance in women with polycystic ovarian syndrome.
This amendment involves the discontinuation of Rezulin treatment in the approximately 120 patients yet to complete the study, the company said, noting it will continue to study therapeutic effects after the treatment is stopped.
Also, Warner-Lambert will delay the initiation of a five-year study to investigate Rezulin's effect in patients with impaired glucose tolerance, a condition of insulin resistance that precedes type 2
diabetes.
Decisions about future studies involving the drug in these populations will be made after the advisory committee meeting.
An ongoing five-year trial in women with a history of gestational diabetes currently in year four will continue.
Warner-Lambert has said that careful monitoring of patients' liver enzymes -- a means of gauging potential toxicity -- has helped to reduce what it termed the already rare risk of serious liver events
and can keep side effects to a minimum.
Deaths have been reported in connection with most, if not all, oral anti-diabetic agents, the company said.
Warner-Lambert has submitted additional packaging information that outlines the symptoms of liver abnormalities and liver enzyme monitoring requirements.
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