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: A Georgia LawyerGA Avandia: TIDE Trial
Looks like folks will have to wait until July of 2010 to see if the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial, commissioned by the FDA and pitting rosiglitazone against pioglitazone (Actos, Takeda Pharmaceuticals), will be allowed to continue.
There are concerns about whether or not the informed consent forms are up to snuff:
"If people were to reexamine the informed-consent forms, particularly in light of the data as of 2010, they may have second thoughts about whether they want to continue the trial at their own institution."
More at the link, above.
Full post as published by A Georgia Lawyer on April 28, 2010 (boomark / email).
Avandia
alleging heart attacks, increased fracture risk that may have been caused by Avandia.
Cipro
The FDA is seeking to add black box warnings of the risk of tendon rupture associated with Cipro and Levaquin.
The ruptures can involve Achilles tendon, shoulder, hand, bicep or thumb tendons, and is especially increased in patients older than 60, or people who have received kidney, heart or lung transplants, as well as people on steroid therapy...
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