Best Evidence Analyses and Commentary

Potential Safety Signal Update
Elliott Cook, PharmD, BCPS

Last quarter, the CDIR Newsletter gave a brief introduction to the Adverse Event Reporting System (AERS) database.  This will be the first quarter that we will be highlighting important potential safety signals from the Food and Drug Administration’s (FDA).   Although it is important to note that the FDA has identified a potential safety issues, it does not mean that the FDA has identified a causal relationship between the drug and the listed risk.1  Despite this, we feel that these are important signals to watch for as potential safety signals can lead to important labeling changes.  

There are a couple of interesting facts about the latest quarterly report.2  Dronedarone was listed with a potential signal of renal impairment, and renal failure.  Dronedarone has been linked to a potential safety signal in every quarter of 2010, and now the first quarter of 2011.  Over the last four quarters dronedarone has been tagged for liver failure and congestive heart failure (which included an updated labeling approved in February),3,4 a drug interaction with warfarin (which included an updated labeling approved in March),5 and Torsade de Pointes that the FDA is still evaluating.6  The latest signal of renal impairment, and renal failure may not be a surprise to some as the product can cause an increase in serum creatinine (already documented in the latest labeling).7  Other note worthy signals included a signal of Sweet’s syndrome with azathioprine which resulted in a labeling change that was updated in May.  Additionally, the following are a few signals the FDA is still evaluating including, pseudotumor cerebri with quinolone products, hypersensitivity reactions due to prasugrel usage, and hypogammaglobulinemia from rituximab.  The full table of the latest quarter report evaluated by the FDA can be located here….January - March 2011.  We feel that keeping abreast of all adverse drug reactions is of vast importance to weigh the risk/benefit of any drug.  The top 200 drugs dispensed in the United States have an average of 105 adverse reactions and recognizing them is a fundamental key to calculating an incidence.8  As always, if an adverse reaction does occur please report it to the FDA here.

REFERENCES

1.  U.S. Food and Drug Administration. Potential signals of serious risks/new safety information identified from the adverse event reporting system (AERS). July 14, 2011. (Accessed August 30, 2011 at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082196.htm.

2. U.S. U.S. Food and Drug Administration. Potential signals of serious risks/new safety information identified from the adverse event reporting system (AERS) between January – March 2011. July 14, 2011. (Accessed August 30, 2011 at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm258366.htm.)

3. U.S. Food and Drug Administration. Potential signals of serious risks/new safety information identified from the adverse event reporting system (AERS) between October – December 2010. July 14, 2011. (Accessed August 30, 2011 at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm249657.htm.)

4. U.S. Food and Drug Administration. Potential signals of serious risks/new safety information identified from the adverse event reporting system (AERS) between January – March 2010. July 14, 2011. (Accessed August 30, 2011 at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm216272.htm.)

5. U.S. Food and Drug Administration. Potential signals of serious risks/new safety information identified from the adverse event reporting system (AERS) between July – September 2010. July 14, 2011. (Accessed August 30, 2011 at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm237585.htm.)

6.  U.S. Food and Drug Administration. Potential signals of serious risks/new safety information identified from the adverse event reporting system (AERS) between April – June 2010. July 14, 2011. (Accessed August 30, 2011 at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm223734.htm.)

7. U.S. Food and Drug Administration. Drugs@FDA. Dronedarone (Multaq). June 2011. (Accessed August 30, 2011 at  http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022425s010lbl.pdf.)

8. Duke J, Friedlin J, Ryan P. A quantitative analysis of adverse events and “overwarning” in drug labeling. Arch Intern Med 2011;171(10):944-6.


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