FDA announces first-time list of "potential" problem drugs

William Atkins
Sunday, 07 September 2008 23:05

Science - Health

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.”