FDA updates warning label for systemic fluoroquinolones 

By: DEEPAK CHITNIS, Ob.Gyn. News Digital Network

 JULY 26, 2016

The Food and Drug Administration has amended the boxed warning on labels for fluoroquinolone antibiotics, taken either orally or by injection, to reflect recent findings of the drugs’ alarming potential adverse events. 

“These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient,” the FDA stated in its Safety Announcement. 

As a result, health care providers should reserve systemic fluoroquinolones for patients who have no other treatment options for any of the following conditions: acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTIs). The FDA also said that, for some serious bacterial infections, the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients taking fluoroquinolones must also be vigilant and let their provider know immediately if they begin suffering from any new pain in their joints, tendons, or muscles. Additionally, if patients begin feeling any numbness in their arms and legs, a prickling or “pins and needles” sensation, or confusion and hallucinations, they should contact their health care provider right away so that they may be switched onto a nonfluoroquinolone antibacterial drug for the remainder of their treatment regimen.

Avelox; Cipro, both standard and extended release; Factive; Levaquin; and ofloxacin are the fluoroquinolones currently approved by the FDA for systemic use. Their active ingredients are moxifloxacin, ciprofloxacin, gemifloxacin, levofloxacin, and ofloxacin, respectively. 

Additional side effects for patients taking fluoroquinolones could include tendinitis, tendon rupture, and joint swelling. Central nervous system afflictions could include depression and thoughts of suicide. Fluoroquinolones could also bring about skin rashes, sunburn, arrhythmia, diarrhea, as well as aggravate myasthenia gravis in patients who suffer from it. Warnings regarding these conditions are already included on the drugs’ existing boxed warning. 

“In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label,” the FDA stated. “The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for ABS, ABECB, and uncomplicated UTIs.”

The FDA also added that it will continue to monitor and assess safety issues associated with fluoroquinolones and will issue any further updates if necessary. 

dchitnis@frontlinemedcom.com