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)
- Codeine-containing cough medicine (Adverse events in children)
- Oral bisphosphonates (Esophageal cancer)
- Mefloquine HCl (Lariam)(Psychiatric events)
- Minocycline (Thyroid disorders)
- Bupivicaine intraarticular injection given by infusion pump (Chondrolysis)
- Selective serotonin and selective norepinephrine reuptake Inhibitors (SSRI and SNRI) antidepressants (Birth defects)
- Propylthiouracil and Methimazole (Hepatotoxicity)
- Phenytoin injection (Cardiac arrest due to rapid injectionK)
- 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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