Potential Signals of Serious Risks/New Safety Information Identified by AERS, January to March 2011
| Product | Potential Signal of a Serious Risk/New Safety Information | Additional Information (as of May 31, 2011) |
| Adalimumab (Humira, Abbot Laboratories) | Hepatic dysfunction, hepatic failure | |
| Azathioprine (Imuran, Prometheus) | Acute febrile neutrophilic dermatosis (Sweet's syndrome) | The label's adverse reactions section was updated in May to include Sweet's syndrome |
| Cetuximab (Erbitux, Eli Lilly and Bristol-Myers Squibb) | Corneal infection, ulcerative keratitis, skin necrosis | |
| Dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) | Labeling for proper storage and handling to preserve potency | The FDA issued a safety communication on March 29 reminding users and pharmacies about the correct handling and storage of the drug |
| Dronedarone HCl (Multaq, Sanofi-Aventis) | Renal impairment, renal failure | |
| Fibrin Sealant (Tisseel VH, Baxter Healthcare; Evicel, Omrix Pharmaceuticals) | Graft failure in ophthalmological procedures and lack of efficacy in neurosurgical procedures for repair of dural tears | Tisseel VH and Evicel have been used off- label in ophthalmological and neurosurgical procedures as tissue adhesives |
| Immune Globulin Subcutaneous (Human) 6% Liquid (Vivaglobin, CSL Behring) | Thromboembolic adverse events have been reported in association with numerous product lots | The product was taken off the market on April 4 |
| Iron sucrose injection (Venofer, Luitpold Pharmaceuticals) | Anaphylactic reactions | |
| Quinolone products | Pseudotumor cerebri | |
| Malathion (Ovide, Taro Pharmaceutical Industries) | Burns and burning sensations | |
| Mercaptopurine (Purinethol, Teva Pharmaceuticals) | Hepatosplenic T-cell lymphoma | |
| Prasugrel HCl (Effient, Eli Lilly) | Hypersensitivity reactions | |
| Rituximab (Rituxan, Roche) | Hypogammaglobulinemia | |
| Ropinirole HCl (Requip, GlaxoSmithKline) | Medication errors resulting from similarities in product name and labeling to risperidone |
