The U.S. Food and Drug Administration (FDA) today released a list of 20 drugs that are on its adverse effect “watch list” — drugs that have potential new serious risks or had new safety information from January to March 2008. The data come from FDA’s Adverse Event Reporting System (AERS) database, its only method for gathering safety and adverse effects about drugs approved for prescribing in the U.S. Adverse events are voluntarily reported by physicians who prescribe the medications.
Two psychiatric medications made the list — Duloxetine (Cymbalta) for a serious risk of urinary retention, and Quetiapine (Seroquel) for overdose due to sample pack labeling confusion.
This is the FDA’s first new public information alert system in years, identifying potential safety issues in drugs and making that information available to the public. The list does not mean that FDA has identified a causal relationship between the drug and the listed risk, but that it’s investigating further to determine if such a relationship exists.
If you’re taking either of the two psychiatric drugs listed, or any of the other listed 18, you should talk to your doctor about the concern the FDA has identified. In terms of Cymbalta, you should talk to your doctor about any problems with retaining urine and in terms of Seroquel, you should double-check with your psychiatrist or doctor to ensure you’ve been prescribed the proper dose.
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