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09/08/2008- The FDA on Sep. 5, 2008 announced that it will publish quarterly a list of drugs that are being evaluated by the agency for its potential risks that have not been known earlier.

The listed drugs will be identified based on a review of reports in the agency's Adverse Event Reporting System (ARS).

The FDA move was authorized by the Food and Drug Administration Amendments Act, a law that got approved on Sept. 27, 2007 as cited below.

Title IX, Section 921 of the Food and Drug Administration Amendments Act 2007 (FDAAA) (121 Stat. 962) amends the Federal Food, Drug and Cosmetic Act (FDCA) to add a new subsection (k)(5) to section 505 (21 U.S.C. 355).

This section in FDAAA, among other things, directs FDA to "conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse Event Reporting System within the last quarter." When a potential signal of a serious risk is identified from AERS data, it will be posted in the required report in the quarter in which it is first identified. A potential signal of a serious risk may in some cases constitute new safety information as defined in FDAAA (newly created section 505-1(b)(3) of the FDCA) which includes, among other things, information derived from adverse event reports about a serious risk associated with use of a drug that FDA has become aware of since the drug was approved or, for drugs that have REMS, since the REMS was required or last assessed. FDA will post each potential signal of a serious risk in the quarter in which it is first identified. If additional new safety information is developed concerning a potential signal that has already been posted, it will be addressed by FDA in new safety communications, but will not appear again as a new quarterly posting.

The law requires that FDA inform the public each quarter of the new safety information or potential serious risks based on the agency's review of the reports in AERS.

The FDA says in its announcement though that getting listed on the quarterly report does not mean the drugs definitely cause the listed risks and a causal relationship has yet to be proved.

Patients should continue taking any drug on the list if their doctors prescribe, said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

The first quarterly report, published on Sep. 5, lists 20 drugs along with their potential safety issue. Future reports will only list NEW drugs that have not been listed in previous reports.

Below are the first quarterly report cited from the FDA website.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)

January - March 2008

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

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