Avandia Research Continues Despite Safety Concerns
Concerns about the safety of Avandia haven't stopped more than 30 clinical trials testing the drug from recruiting new patients, according to data on the website www.clinicaltrials.gov
There are currently 32 Avandia trials around the country recruiting new patients even though critics say a competitor drug Actos may be just as effective and safer.
For example, there are two ongoing Avandia trials at Brooke Army Medical Center in San Antonio, TX. One of the trials is run in conjunction with GlaxoSmithKline PLC, manufacturer of the drug.
GlaxoSmithKline dismissed the findings of the studies released today, citing "limitations" in them. The company pointed to its postive research results on Avandia/rosilglitazone: "Results from six controlled clinical trials (RECORD,1 APPROACH,2 VICTORY,3 VADT,4 ACCORD5 and BARI-2D6) have been reported since the Joint Advisory Committees of the Food and Drug Administration (FDA) reviewed questions about the cardiovascular safety of rosiglitazone in 2007. Taken together, these trials show that rosilglitazone does not increase the overall risk of heart attack, stroke or death."
Today's studies come on the heels of an internal FDA document released in February showing that two FDA safety reviewers wanted the drug pulled from the market because of serious concerns about the drug's safety. The reviewers were so worried they said asking the company to continue to run safety trials would be "unethical" because it would continue to expose patients to a potentially dangerous drug.
On July 13th, the FDA will hold an advisory committee meeting to discuss the safety of Avandia.
See also:
Diabetes Drug Avandia Tied to Major Health Risks