The US Food and Drug Administration's early warning system has issued a list of drugs to review. Information on possible problems with these drugs was collected from hospitals, patients, doctors and drug companies.
A drug being on this list doesn't mean it is unsafe: it means it may be linked with a problem. So don't stop your medicine just because it is on the list; talk to your doctor.
- Arginine hydrochloride injection (R-Gene 10): overdose in children due to confusing labelling
- Desflurane (Suprane): cardiac arrest
- Duloxetine (Cymbalta): urinary retention
- Etravirine (Intelence): bleeding into the joints
- Fluorouracil cream (Carac) and ketoconazole cream (Kuric): side effects due to name confusion
- Heparin: allergic reactions
- Icodextrin (Extraneal): low blood sugar
- Insulin U-500 (Humulin R): dosing confusion
- Ivermectin (Stromectol) and warfarin: drug interaction
- Lapatinib (Tykerb): liver toxicity
- Lenalidomide (Revlimid): Stevens-Johnson syndrome
- Natalizumab (Tysabri): skin melanoma
- Nitroglycerin (Nitrostat): overdose due to unclear labelling
- Octreotide acetate depot (Sandostatin LAR): bowel obstruction (ileus)
- Oxycodone controlled-release (OxyContin): misuse and overdose
- Perflutren lipid microspheres (Definity): heart and lung reactions
- Phenytoin injection (Dilantin): purple glove syndrome (discoloured, painful, swollen hand, sometimes leading to amputation)
- Quetiapine (Seroquel): overdose due to confusing labels
- Telbivudine (Tyzeka): peripheral nerve damage
- TNF blockers: cancer in children and adults
The FDA will assess these reports further and, depending on the outcome, either withdraw a drug or keep it on the market with warnings.
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