Table 1. Label Information on ADRs for each drug.
| Drug | ADRs | US drug release | Label information at drug release | FDA-issued advisory information | Label revision |
|---|---|---|---|---|---|
| Known ADRs | |||||
| Rosuvastatin | Rhabdomyolysis | August 2003 | WARNING | ||
| Aripiprazole | Malignant syndrome | November 2002 | WARNING | ||
| Teriparatide | Hypercalcemia | November 2002 | PRECAUTION | ||
| Unknown ADRs | |||||
| Telithromycin | Severe liver injury | April 2004 | January 2006 | June 2006 (added to WARNING) | |
| Varenicline | Suicidal behavior | March 2006 | November 2007 May 2008 | January 2008 (added to WARNING) | |
| Exenatide | Pancreatitis | April 2005 | October 2007 August 2008 | January 2008 (added to PRECAUTIONS) |