FDA posts list of drugs that may be unsafe

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Score one for the consumer. The U.S. Food and Drug Administration today published its first list of drugs that are on the market and being used by consumers but are under review for potential safety issues.

The list, which will be updated quarterly, was part of the FDA Amendments Act, signed into law one year ago. The law requires that the FDA inform the public each quarter of new safety information or potential signals of serious risk based on the agency’s review of adverse event reports.


The FDA explains the list: ‘The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue.’

Dr. Janet Woodcock, direct of the FDA’s Center for Drug Evaluation and Research added:

‘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.’

The list contains 20 drugs along with the potential safety issue of each drug. Today’s report includes the antidepressant Cymbalta and links to urinary retention; the multiple sclerosis drug Tysabri and reports of melanoma skin cancer, and the drug Revlimid for multiple myeloma that is linked to a life-threatening skin condition called Stevens Johnson Syndrome.

The list comes in response to complaints by the public and physicians that they aren’t being told soon enough of potential safety problems reported to the FDA. Sometimes pre-marketing clinical trials do not produce evidence of a safety problem and it is only when the drug is in wide use that a problem emerges. The list will not be a comprehensive summary of all the drugs the FDA may be working on. Each new quarterly report will contain new listings; the lists will not be cumulative. You can read about the program at the FDA’s website and see the current list of potentially unsafe drugs.

-- Shari Roan