FDA puts rosiglitazone post-marketing trial on holdBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c4017 (Published 26 July 2010) Cite this as: BMJ 2010;341:c4017
- Deborah Cohen
The US Food and Drugs Administration has suspended a post-marketing trial of the thiazolidinedione rosiglitazone while it looks at whether to withdraw the drug or keep it on the market.
The thiazolidinedione intervention with vitamin D evaluation (TIDE) trial was designed to compare the cardiovascular safety of rosiglitazone (marketed as Avandia) and pioglitazone (Actos) in patients with type 2 diabetes. It was set up at the FDA’s request in 2007.
The FDA has placed a “partial clinical hold” on the trial, which means that no new patients can be enrolled until further notice. Patients already enrolled in the trial will be allowed to continue.
This follows the suspension by India’s drug controller general of the trial at the …