Petition Seeks Warning on Fluoroquinolone Guides

Three individuals have submitted a petition to FDA asking that the agency add language from the fluoroquinolone Boxed Warning to the top of the Medication Guide for all such antibiotics. The petition says the change would address the Boxed Warning that serious adverse reactions including tendonitis, tendon rupture, peripheral neuropathy, and central nervous system effects are associated with fluoroquinolones such as Janssen’s Levaquin (levofloxacin) and Bayer’s Cipro (ciprofloxacin).

Adding the information to the Medication Guide, the petition says, would:

• improve the quality of fluoroquinolone safety information provided to patients;
• provide additional drug safety information that will enable patients to make better informed decisions before taking the drug; and
• improve overall patient safety related to fluoroquinolones.

The petition notes that on 7/26/2016 the fluoroquinolone manufacturers updated the Boxed Warnings to include the language highlighted in the petition and also added the language to the Warnings and Precautions section of the labeling. But it was not added to the Medication Guides and thus “for the past seven years, patients have not received the critically important information about potentially serious, disabling, irreversible adverse events contained in the Boxed Warnings…. And, for the past seven years, patients have not received the critically important information that fluoroquinolones are not recommended for urinary tract infection, bronchitis, or sinusitis unless there is no other appropriate alternative, as indicated in the Boxed Warnings.”

The petitioners say there is an urgency to approve their request so patients can read the important information from the Boxed Warning at the top of the Medication Guide when they receive a fluoroquinolone prescription.

“Some may argue that providing this information, already found in the Boxed Warning and Warnings and Precautions sections of the fluoroquinolone labels, may discourage patients from consuming a prescribed fluoroquinolone,” they write. “But this argument is not a valid excuse for failing to tell patients that fluoroquinolones are associated with ‘disabling and potentially irreversible serious adverse reactions.’ Patients expect and deserve to receive accurate, robust, comprehensive information about the fluoroquinolone prescribed, including about ‘disabling and potentially irreversible adverse reactions.’”