During the past two days, diabetes drug Avandia has been under review regarding its safety issues and future existence in the pharmaceutical drug market. A U.S. Food and Drug Administration advisory panel declared Wednesday that the drug can remain on the market with tightened regulation and certain restrictions to sales efforts.
The panel of 33 experts reviewed a study conducted by the maker of Avandia, GlaxoSmithKline, which evaluated the drugs safety. The trial's validity was controversial as several reviewing scientists pointed out minor flaws in the study that favored the safety of Avandia, leading one panelist to withdraw from voting. As for the remaining advisors on the panel, 12 voted to eliminate Avandia from the market, 10 voted to allow the drug to remain on the market with extensive label revisions and possible sales restrictions, seven voted to implement additional warnings to the label, and three panelists voted to maintain the drug's market presence with no change.
Also interested in outcome of the review are those within the legal industry, particularly dangerous and defective drug lawyers. Dozens of contradictory trials of Avandia failed to show enough evidence to justify dropping the drug which is used by thousands of diabetes patients.
"I would be concerned about the precedent that would be set to have this quality of data sufficient to remove a drug," said John Teerlink of the University of San Francisco.
Potential pharmaceutical drug litigations are prompting some dangerous drug lawyers to obtain information about the review which could serve valuable in the case of a defective drug incident.
Additionally, the panel majority voted to continue with the trial regarding Thiazolidinedione Intervention With Vitamin D Evaluation, which serves to analyze the cardiovascular effects of treatment with Avandia, Actos (also known as pioglitazone, an alternative to Avandia), or a placebo when implemented to certain drug treatment plans in patients with type 2 diabetes and who have a risk (or history) of cardiovascular disease.
"The advisory committee's deliberations were difficult, since the available data were limited, controversial, and subject to multiple interpretations by seasoned investigators and reviewers," said American Heart Association president Ralph Sacco, M.D. "We agree with the committee that further research is necessary to answer the remaining questions, and we encourage the FDA to continue to evaluate and assess carefully all new clinical data as they become available."
Meanwhile, dangrous drug law firms continue to assess the research and available clinical data. Concerns about pharmaceutical safety has been a primary focus for a number of drug litigation lawyers as well as the individuals who use such drugs for diabetes treatment.
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