Safety Labeling Changes for Fluoroquinolones

The U.S. Food and Drug Administration (FDA) has recently announced labeling changes for antibacterial drugs known as fluoroquinolones.  Fluoroquinolone drugs are used to kill or stop the growth of bacteria that can cause illnesses.  This announcement includes an updated boxed warning along with stating that the serious side effects of these types of drugs generally outweigh the benefits to the patient especially when the illness is uncomplicated and has other treatment options.  According to the FDA, fluoroquinolones should be reserved for patients who do not have alternative treatment options.

Safety reviews completed by the FDA have shown that when fluoroquinolones are used systemically, meaning tablets, capsules or injectable dosage forms, they are associated with disabling and sometimes permanent side effects.  These drugs can affect the tendons, muscles, joints and even the central nervous system.  Due to the severity of these drugs, the FDA is requiring labelling changes for all fluoroquinolone antibacterial drugs to reflect this critical safety information.  The FDA has stated that they will be continuing to investigate safety issues with these drugs and will notify the public with suplementary information if it becomes available.

We hope that this information is helpful to you.  If you have any questions about requirements, please feel free to contact Focal Point Research.  We are industry leading consultants that you can trust to help guide your company in the right direction.