FDA Side-Effects Probe

9.8.08

in Healthcare

Probings: here, here and here:

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

Fortunately, H2O is not under investigation yet…

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