FDA Requires Safety Label Changes for Fluoroquinolones

Share this content:
FDA Requires Safety Label Changes for Fluoroquinolones
FDA Requires Safety Label Changes for Fluoroquinolones

WEDNESDAY, July 11, 2018 (HealthDay News) -- The U.S. Food and Drug Administration has strengthened current warnings in the prescribing information about fluoroquinolone antibiotics causing significant decreases in blood glucose as well as mental health side effects.

The low blood glucose levels induced by fluoroquinolone antibiotics can result in health problems, including coma, especially among older people and those with diabetes who are on medications to reduce blood glucose. Patients with diabetes may be asked to check blood glucose more often while taking a fluoroquinolone. Health care professionals should discuss treatment in cases where a patient suspects low blood glucose. Updates are required in the drug labels and to the patient Medication Guide for the entire class of fluoroquinolones. The new label changes will make the mental health side effects more prominent, and more consistent across the entire class.

Reports of cases submitted to the FDA and published medical literature of apparently healthy patients who experienced serious changes in mood, behavior, and blood glucose levels while being treated with systemic fluoroquinolones were reviewed. Several changes to the Warnings and Precautions section of fluoroquinolone drug labels are being required; these include describing hypoglycemic coma, and the new subheading "Psychiatric Adverse Reactions," which will help clarify and identify the mental health side effects.

The report "[urges] patients and health care professionals to report side effects involving fluoroquinolones or other drugs to the FDA MedWatch program."

Press Release
Safety Announcement

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

CDC: Many Americans May Have Prediabetes and Not Know It

CDC: Many Americans May Have Prediabetes and Not ...

AMA, CDC launch a campaign to raise awareness about prediabetes

Low-Carbohydrate Diets Linked to Increase in Calories Burned

Low-Carbohydrate Diets Linked to Increase in Calories Burned

Total energy expenditure is greater for those on a low- or moderate-carb diet during weight-loss maintenance

Many Patients Do Not Engage Health Care Provider During MS Relapse

Many Patients Do Not Engage Health Care Provider ...

Only half of patients reported always engaging health care providers

is free, fast, and customized just for you!




Already a member?

Sign In Now »