The battle against rising antibiotic overuse and dependence continues. This time, a safety announcement focused on the potential side effects that render some benefits insignificant.
The U.S. Food and Drug Administration (FDA) said the side effects of common antibiotics outweigh the benefits in some infections.
The FDA announcement focused on fluoroquinolone antibacterial drugs, including the common, powerful antibiotic ciprofloxacin, which is used to treat people with uncomplicated urinary tract or sinus infections or bronchitis.
Ciprofloxacin (marketed as Cipro) is manufactured by Bayer AG and has been on the market for more than two decades. Another fluoroquinolone antibacterial drug is levofloxacin (marketed as Levaquin), manufactured by Johnson & Johnson. Levaquin is often prescribed to patients with urinary tract infections and prostatitis, which is an infection of the prostate.
The FDA advised doctors to only prescribe these drug types as a last resort.
"An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules and injectable) are associated with disabling and potentially permanent serious side effects that can occur together," wrote the FDA in the safety announcement.
The accompanying side effects often distress the muscles, nerves, joins, tendons and the central nervous system. Patients might experience a prickling sensation as well as hallucinations and confusion.
The federal agency also encouraged patients who may experience such side effects to see their doctors right away if they're using the abovementioned drug types.
Doctors are advised to stop the treatment right away if the patient is experiencing any severe side effects to the said drugs. The FDA encouraged switching to a non-fluoroquinolone drug to complete the patient's therapy.
The FDA is also requiring a label update on these fluoroquinolone antibacterial drugs to show the new safety information. The agency made similar announcements in July 2008 and August 2013.
Bayer said it will work closely with the federal health agency on the new safety statement while Johnson & Johnson said it is studying the FDA announcement.
The FDA added that it will continue to investigate the antibiotics' safety issues. Further information will be issued to the public once they are available.
