Technology news and Jobs arrow Science arrow FDA announces first-time list of "potential" problem drugs
FDA announces first-time list of "potential" problem drugs E-mail
by William Atkins   
Monday, 08 September 2008


The list of drug products, with its active ingredient (trade name) or product class, along with their potential signs of serious risk is shown below:

•    Arginine Hydrochloride Injection (R-Gene 10), a growth hormone
     o    pediatric overdose due to labeling/packaging confusion
•    Desflurane (Suprane), an anesthetic
     o    cardiac arrest
•    Duloxetine (Cymbalta), for depression and other conditions
     o    Urinary retention
•    Etravirine (Intelence), an HIV medication, bleeding into joints
     o    Hemarthrosis
•    Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric), creams for skin conditions and fungal infections
     o    Adverse events due to name confusion
•    Heparin, a blood-thinner, serious allergic reactions
     o    Anaphylactic-type reactions
•    Icodextrin (Extraneal), used in kidney dialysis, low blood sugars
     o    Hypoglycemia
•    Insulin U-500 (Humulin R), insulin for diabetes
     o    Dosing confusion
•    Ivermectin (Stromectol) and Warfarin, an anti-parasite drug and a blood thinner
     o    Drug interaction
•    Lapatinib (Tykerb), for advanced breast cancer, liver damage
     o    Hepatotoxicity
•    Lenalidomide (Revlimid), for multiple myeloma, severe skin blistering and bleeding
     o    Stevens Johnson Syndrome
•    Natalizumab (Tysabri), for multiple sclerosis
     o    Skin melanomas.
•    Nitroglycerin (Nitrostat), for angina,
     o    Overdose due to labeling confusion
•    Octreotide Acetate Depot (Sandostatin LAR), for abnormal bone growth, bowel obstruction
     o    Ileus
•    Oxycodone Hydrochloride Controlled-Release (Oxycontin), a pain killer
     o    Drug misuse, abuse and overdose
•    Perflutren Lipid Microsphere (Definity), used in cardiac imaging
     o    Cardiopulmonary reactions
•    Phenytoin Injection (Dilantin), for epileptic seizures, serious skin reaction
     o    Purple Glove Syndrome
•    Quetiapine (Seroquel), for bipolar disorder
     o    Overdose due to sample pack labeling confusion
•    Telbivudine (Tyzeka), for chronic hepatitis B, nerve damage
     o    Peripheral Neuropathy
•    Tumor Necrosis Factor (TNF) Blockers, for juvenile arthritis
     o    Cancers in children and young adults

The list also appears on the FDA website “Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
January - March 2008.”

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