Potential Signals of Serious Risks
The table below lists the names of products and potential signals of serious
risks/new safety information that were identified for these products during the
period January - March 2008 in the AERS database. The appearance of a drug on
this list does not mean that FDA has concluded that the drug has the listed
risk. It means that FDA has identified a potential safety issue,
but does not mean that FDA has identified a causal relationship between the drug
and the listed risk. If after further evaluation the FDA determines that the
drug is associated with the risk, it may take a variety of actions including
requiring changes to the labeling of the drug, requiring development of a Risk
Evaluation and Mitigation Strategy (REMS), or gathering additional data to
better characterize the risk.
FDA wants to emphasize that the listing of a drug and a potential safety
issue on this Web site does not mean that FDA is suggesting prescribers should
not prescribe the drug or that patients taking the drug should stop taking the
medication. Patients who have questions about their use of the identified drug
should contact their health care provider. FDA will complete its evaluation of
each potential signal/new safety information and issue additional public
communications as appropriate.
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 |