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Posted by David Elkins and others

Future looks bleak for Avandia as safety trial put on hold

Last week saw an rule that there is reason to believe the troubled diabetes drug Avandia (rosiglitazone) does indeed increase cardiovascular risks compared to its direct competitor Actos (pioglitazone).

Now, the FDA appears to be moving to shut down the Canadian-led trial that represented the last chance for maker GlaxoSmithKline to prove its drug is safe. The agency put a "partial clinical hold" on new recruitment for the trial while it updates the lead investigators - Drs Salim Yusef and Hertzel Gerstein of McMaster University - on the results of last week's panel meeting.

While the FDA safety panel stopped short of voting to remove Avandia from the market, the agency can still take action without a vote, and most observers suspect the end is near for Avandia, which has already seen sales collapse in the wake of data suggesting it increases cardiovascular events.

In fact, the same safety concerns were inhibiting recruitment to the TIDE trial. GSK, which agreed in 2007 to fund a head-to-head comparison with pioglitazone, said last week that only 1,100 of an intended 16,000 study participants have volunteered to date.

Posted by David Elkins and others at 4:30 PM

1 comments:

sharon(aka Purley Quirt ) said...

I would like to see/know who is behind the thrust to use diabetes medication as a prophylactic measure ( including insulin).

Is this ever increasing drug dependent society ( at every level) ever going to ask who is behind it?

I am very intrigued by this new push by pharmacia to make physicians feel the time they spend on alternates to drugs ( teaching, training, lifestyle change)is a sign of ? failing to serve the best interests of the patient .

24 July, 2010 6:40 AM