FDA Reports Latest List of Potentially Risky Drugs

The FDA has just released its quarterly Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008. The FDA has identified potential safety issues, but this does not mean that FDA has identified a causal relationship between the drug and the listed risk. I've listed the July - Sept '08 list of affected drugs here . . . Product Name: Active Ingredient (Trade) or Product Class (Potential Signal of Serious Risk/New Safety Information)

1. Codeine-containing cough medicine (Adverse events in children)
2. Oral bisphosphonates (Esophageal cancer)
3. Mefloquine HCl (Lariam)(Psychiatric events)
4. Minocycline (Thyroid disorders)
5. Bupivicaine intraarticular injection given by infusion pump (Chondrolysis)
6. Selective serotonin and selective norepinephrine reuptake Inhibitors (SSRI and SNRI) antidepressants (Birth defects)
7. Propylthiouracil and Methimazole (Hepatotoxicity)
8. Phenytoin injection (Cardiac arrest due to rapid injectionK)
9. Terbinafine (Lamisil) oral use (Psychiatric events)

For more complete FDA information: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) Quarterly Reports 2008 January to March 2008 April to June 2008 July to September

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20 Drugs - New FDA Safety Info

The FDA began posting a list of prescription drugs under investigation for potential safety problems, in an effort to better inform doctors and patients. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). Here are the results of their very first quarterly report, Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS): January - March 2008.

The FDA list is a bare-bones compilation naming 20 medications and the potential issue for each. This Reuter's news article provides a little more information about the 20 drugs, and is a little easier to digest, "FACTBOX: Drugs on U.S. FDA list for possible risks."

Bottomline
As stated in the FDA news release, "My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research."

Additional Information Sources

1. FDA to Post Quarterly Report of Potential Safety Issues (news release)
2. Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) - links to quarterly reports

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