Tuesday, July 19, 2011

The FDA has published its latest quarterly list of drugs to monitor after having identified potential signs of serious risks or new safety information. The new watch list covers the first 3 months of 2011. Here's the list for 2011 so far: 

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