Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 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 July - September 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 from the Adverse Event Reporting System (AERS) between July - September 2008

Product Name: Active Ingredient (Trade)
or Product Class
Potential Signal of Serious Risk/New Safety InformationAdditional Information Available as of January 30, 2009
Codeine-containing cough medicine Adverse events in children

This issue is part of FDA’s ongoing effort to monitor the safety of cough and cold medicines in children.

FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children

Information on Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)

Oral bisphosphonates Esophageal cancer FDA is continuing to evaluate this issue to determine the need for any regulatory action. FDA staff published a summary of case reports in the New England Journal of Medicine in January 2009. [external link]
Mefloquine HCl (Lariam) Psychiatric events

FDA is reevaluating the adequacy of current labeling, which already addresses psychiatric events under Warnings.

Lariam labeling

Minocycline Thyroid disorders FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Bupivicaine intraarticular injection given by infusion pump Chondrolysis FDA (CDER and CDRH) is evaluating this issue involving local infusion for postoperative pain, which is an unapproved use.
Selective serotonin and selective norepinephrine reuptake Inhibitors (SSRI and SNRI) antidepressants Birth defects FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Propylthiouracil and Methimazole Hepatotoxicity

FDA and the National Institute of Child Health and Human Development have met and are evaluating this issue to improve understanding of liver damage following treatment of hyperthyroidism in children.
Minutes from Meeting on Hepatic Toxicity Following Treatment for Pediatric Graves’ Disease, October 28, 2008

Phenytoin injection Cardiac arrest due to rapid injection FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Terbinafine (Lamisil) oral use Psychiatric events This issue was identified during a review of terbinafine adverse events as required by the Best Pharmaceuticals for Children Act. Information from a review of the AERS database was presented at a November 2008 advisory committee meeting.  FDA is continuing to evaluate this issue in all age groups to determine the need for any regulatory action.

 

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