The FDA has announced that it will post quarterly reports on its Web site that list certain drugs that are being evaluated for potential safety issues.  The FDA said it will determine which drugs will be included in the reports by reviewing its adverse event reporting system (AERS).  The agency said that the appearance of a drug on this list does not mean that the FDA has concluded that the drug has the listed risk or that the FDA has identified a causal relationship between the drug and the listed risk.

 

For a drug to appear on the report, titled Potential Signals of Serious Risks/New Safety Information, a reviewer must determine there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug.  The first quarterly report lists 20 drugs along with the potential safety issue associated with each drug. 

 

Drugs mentioned in the quarterly report include:

 

Product Name: Active Ingredient (Trade) or Product Class	Potential Signal of Serious Risk/New Safety Information
Duloxetine (Cymbalta)	Urinary retention
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric)	Adverse events due to name confusion
Heparin	Anaphylactic-type reactions
Oxycodone Hydrochloride Controlled-Release (Oxycontin)	Drug misuse, abuse, and overdose
Telbivudine (Tyzeka)	Peripheral neuropathy

 

To view the quarterly report, please visit the FDA website.

 

 

To view the advisory, please visit the FDA website.