Drug Makers Must Add Stronger Fluoroquinolone Label Warnings

Drug Makers Must Add Stronger Fluoroquinolone Label Warnings

Introduction

Following numerous reports on the risk of hypoglycemic (low blood sugar) coma associated with the antibiotic class fluoroquinolones, the U.S. FDA announced the Fluoroquinolones makers must include a strong label warning to alert patients. About 13 patients succumbed to death due to hypoglycemia between October 1987 and April 2017 while under fluoroquinolone medication.

Some of the patients were treated for relatively uncomplicated infections or were under post-surgery treatment. Few others who took the drug became disabled. The FDA specified the blood glucose disturbances subsection of the product label must reflect hypoglycemia risk. The patients are required to inform doctors if they are already under a diabetes treatment since the fluoroquinolone related hypoglycemia is mostly seen in diabetic and older patients. In addition to hypoglycemia, the FDA also ordered that all drugs like levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox) belonging to the same class to have uniform label warnings about the mental health side effects which include Disturbances inattention, Disorientation, Agitation, Nervousness, Memory impairment and Delirium.

Lawsuits filed in several state courts blame the manufacturers Bayer Healthcare Pharmaceuticals, Merck & Co, Johnson & Johnson and others of marketing defective and dangerous drugs. Attorneys handling the cases assert the drug makers were aware of the aortic risks of fluoroquinolones but failed to adequately warn patients and doctors.