Table 3.
Drugs Which Had Safety Alert/Label Change Notification by FDA Between 2009 and 2013 and Difference in Number of Reports, ROR and PRR Before and After Safety Alert.
| Drug | Safety alert | Date of alert | Number of reports before | Number of reports after | ROR before | ROR after | PRR before | PRR after |
|---|---|---|---|---|---|---|---|---|
| Zoledronic acid | Renal impairment | March 13, 2009 | 61 | 91 | 0.44 | 0.49 | 0.44 | 0.49 |
| Ceftriaxone | Hemolytic anemia | June 7, 2009 | 5 | 12 | 6.45 | 12.46 | 6.48 | 12.74 |
| Varenicline | Visual impairment | July 01, 2009 | 6 | 11 | 1.08 | 1.12 | 1.09 | 1.13 |
| Montelukast | Suicidal behavior | August 19, 2009 | 322 | 274 | 8.77 | 3.35 | 9.60 | 3.41 |
| Didanosine | Portal hypertension | January 25, 2010 | 21 | 6 | 341.80 | 525.86 | 470.53 | 607.94 |
| Trazodone | Prolongation of the electrocardiogram QT interval | February 02, 2010 | 6 | 23 | 4.08 | 4.32 | 4.06 | 4.31 |
| Propylthiouracil | Hepatotoxicity | April 1, 2010 | 5 | 1 | 13.23 | 38.41 | 13.04 | 37.14 |
| Orlistat | Hepatotoxicity | May 25, 2010 | 104 | 58 | 0.50 | 1.23 | 0.50 | 1.22 |
| Solifenacin | Angioedema | July 12, 2010 | 0 | 2 | 0.77 | 0.71 | 0.77 | 0.71 |
| Minocycline | DRESS | September 14, 2010 | 26 | 0 | 45.45 | 6.96 | 43.59 | 6.92 |
| Tapentadol hydrochloride | Serotonin syndrome | November 1, 2010 | 9 | 9 | 19.70 | 40.31 | 19.33 | 39.47 |
| Oxybutynin chloride | Angioedema | January 31, 2011 | 4 | 3 | 1.28 | 1.70 | 1.28 | 1.70 |
| Doxycycline hyclate | Stevens Johnson Syndrome | March 21, 2011 | 3 | 3 | 2.72 | 6.45 | 2.73 | 6.49 |
| Finasteride | Male breast cancer | April 13, 2011 | 3 | 5 | 77.45 | 37.60 | 93.67 | 41.80 |
| Lanthanum carbonate | Intestinal obstruction | April 27, 2011 | 3 | 12 | 0.983 | 0.52 | 0.98 | 0.53 |
| Simvastatin | Muscle injury | June 8, 2011 | 19 | 10 | 9.87 | 9.01 | 13.15 | 10.90 |
| Dutasteride | Male breast cancer | June 9, 2011 | 4 | 3 | 70.33 | 146.97 | 83.19 | 192.56 |
| Leuprolide acetate | Osteopenia | June 17, 2011 | 14 | 13 | 0.59 | 0.21 | 0.59 | 0.21 |
| Dronedarone hydrochloride | Pulmonary toxicity | June 21, 2011 | 8 | 5 | 10.89 | 29.86 | 11.17 | 30.80 |
| Bevacizumab | Osteonecrosis of jaw | September 30, 2011 | 14 | 18 | 4.43 | 2.52 | 4.51 | 2.56 |
| Infliximab | Sarcoidosis | October 26, 2011 | 20 | 17 | 5.67 | 2.04 | 6.12 | 2.09 |
| Voriconazole | Periostitis | November 16, 2011 | 11 | 1 | 224.86 | 195.93 | 362.26 | 301.37 |
| Adalimumab | Optic neuritis | December 26, 2011 | 19 | 16 | 1.72 | 0.74 | 1.77 | 0.74 |
| Solifenacin succinate | Somnolence | January 17, 2012 | 4 | 8 | 0.19 | 0.28 | 0.19 | 0.28 |
| Drospirenone | Pancreatitis | February 13, 2012 | 6 | 1 | 3.73 | 3.36 | 3.86 | 3.44 |
| Pegloticase | Anaphylaxis | April 16, 2012 | 46 | 7 | 42.80 | 74.69 | 38.92 | 65.03 |
| Trospium chloride | Somnolence | July 23, 2012 | 1 | 4 | 0.03 | 0.01 | 0.04 | 0.01 |
| Tolterodine tartrate | Somnolence | August 1, 2012 | 2 | 4 | 1.48 | 1.18 | 1.48 | 1.18 |
| Fesoterodine fumarate | Somnolence | August 1, 2012 | 18 | 12 | 2.55 | 1.78 | 2.52 | 1.77 |
| Dalfampridine | Anaphylaxis | January 22, 2013 | 3 | 2 | 0.55 | 0.27 | 0.56 | 0.27 |
| Lacosamide | Neutropenia | April 17, 2013 | 3 | 1 | 0.79 | 0.69 | 0.79 | 0.69 |
Note. FDA = US Food and Drug Administration; ROR = reporting odds ratio; PRR = proportional reporting ratio; DRESS = drug reaction with eosinophilia and systemic symptoms.