FDA Watch List: Fluoroquinolone

Fluoroquinolone antibiotics that are commonly taken to treat respiratory or urinary tract infections have been listed on the Food and Drug Administration’s most recent “Adverse Event Reporting System” list. 

The reason for their inclusion on the list is the FDA’s need to investigate a potential link between the antibiotics’ usage and peripheral sensorimotor neuropathy. According to the MedlinePlus Medical Encyclopedia, sensorimotor polyneuropathy is defined as “a body-wide (systemic) process that damages nerve cells, nerve fibers (axons), and nerve coverings.”

The list also mentions that the FDA was continuing to evaluate the labeling of all fluoroquinolone antibiotic products to determine if the warnings about peripheral sensorimotor neuropathy are appropriate and need to be strengthened.

The AERS list documents potential safety risks that were gathered during the final three months of 2011.

It is important to note that the FDA has not yet determined whether or not products listed on the AERS watch list pose a health risk. Instead, it means that additional studies will be undertaken to see if there is a link between the product and a potential health risk. Possible regulatory responses, such as a change in the product’s labeling or a recall, could be pursued by the FDA if such a link is found.

If you or a loved one has been harmed by a dangerous drug, there are legal actions at your disposal. Call Sokolove Law to learn more about pursuing a dangerous drug lawsuit today. For legal help, call (877) 490-6520.

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