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FDA's Quarterly Report: products and potential signals of serious risks/new safety information, AERS database.

Sept 5, 2008 FDA announced (1) that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues.(2) The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).
FDAAA, signed into law Sept. 27, 2007, requires that FDA inform the public each quarter of new safety information or potential signals of serious risk, based on the agency's review of adverse event reports contained in AERS. When a potential signal of a serious risk is identified from AERS data, it is entered as a safety issue into CDER's Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) or into CBER's Therapeutics and Blood Safety Branch Safety Signal Tracking (SST) system.

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue...
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.

This first Quarterly Report's drug list (Jan.-Mar. 2008) identifies potential drug risks such as:
Dosing confusion, Drug interaction, Pediatric overdose due to labeling / packaging confusion, Overdose due to labeling confusion, Drug misuse, abuse and overdose, Overdose due to sample pack labeling confusion, Adverse events due to name confusion,
Cardiac arrest, Cardiopulmonary reactions, Anaphylactic-type reactions
Hepatotoxicity , Hypoglycemia, Urinary retention, Peripheral neuropathy,
Skin melanomas, Cancers in children and young adults.
The quarterly reports will not be cumulative; they will list only drugs for which new safety information or potential signals of serious risks have been identified through AERS during the previous quarter.
(1)http://www.fda.gov/bbs/topics/NEWS/2008/NEW01881.html
(2)http://www.fda.gov/cder/aers/potential_signals/default.htm

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.

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This page contains a single entry from the blog posted on September 6, 2008 4:33 PM.

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