| |
| | FDA Warning Letter, GlaxoSmithKline (Avandia® (rosiglitazone maleate) Tablets) |
 | | Additionally, they fail to present the warning from the PI that, in clinical trials, there was an increased incidence of CHF and other cardiovascular adverse events in patients on Avandia and insulin combination therapy compared to insulin plus placebo. |
 | | In two previous untitled letters, dated June 29, 1999, and October 20, 2000, we objected to your dissemination of promotional materials for Avandia that lacked fair balance concerning the risks associated with Avandia, minimized the hepatic risks, and contained misleading efficacy claims. |
 | | After agreement is reached on the content and audience, the letter should be disseminated by direct mail to all healthcare providers who were, or may have been exposed to the violative promotion. |
| www.pharmcast.com /warningletters/Yr2001/July2001/Glaxo0701.htm (1382 words) |
|