Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008
| Product Name: Active Ingredient (Trade) or Product Class | Potential Signal of Serious Risk/New Safety Information |
|---|---|
| Arginine Hydrochloride Injection (R-Gene 10) | Pediatric overdose due to labeling / packaging confusion |
| Desflurane (Suprane) | Cardiac arrest |
| Duloxetine (Cymbalta) | Urinary retention |
| Etravirine (Intelence) | Hemarthrosis |
| Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) | Adverse events due to name confusion |
| Heparin | Anaphylactic-type reactions |
| Icodextrin (Extraneal) | Hypoglycemia |
| Insulin U-500 (Humulin R) | Dosing confusion |
| Ivermectin (Stromectol) and Warfarin | Drug interaction |
| Lapatinib (Tykerb) | Hepatotoxicity |
| Lenalidomide (Revlimid) | Stevens Johnson Syndrome |
| Natalizumab (Tysabri) | Skin melanomas |
| Nitroglycerin (Nitrostat) | Overdose due to labeling confusion |
| Octreotide Acetate Depot (Sandostatin LAR) | Ileus |
| Oxycodone Hydrochloride Controlled-Release (Oxycontin) | Drug misuse, abuse and overdose |
| Perflutren Lipid Microsphere (Definity) | Cardiopulmonary reactions |
| Phenytoin Injection (Dilantin) | Purple Glove Syndrome |
| Quetiapine (Seroquel) | Overdose due to sample pack labeling confusion |
| Telbivudine (Tyzeka) | Peripheral neuropathy |
| Tumor Necrosis Factor (TNF) Blockers | Cancers in children and young adults |
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