The United States Food and Drug Administration (FDA) has strengthened the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
The low blood sugar levels can result in serious problems, including coma, particularly in older people and patients with diabetes who are taking medicines to reduce blood sugar. We are making these changes because our recent review found reports of life-threatening low blood sugar side effects and reports of additional mental health side effects. We are requiring these updates in the drug labels and to the patient Medication Guides for the entire class of fluoroquinolones. This affects only the fluoroquinolone formulations taken by mouth or given by injection. Blood sugar disturbances, including high blood sugar and low blood sugar, are already included as a warning in most fluoroquinolone drug labels; however, we are adding that low blood sugar levels, also called hypoglycemia, can lead to coma.
Across the fluoroquinolone antibiotic class, a range of mental health side effects are already described under Central Nervous System Effects in the Warnings and Precautions section of the drug label, which differed by individual drug. The new label changes will make the mental health side effects more prominent and more consistent across the systemic fluoroquinolone drug class. The mental health side effects to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.
Fluoroquinolone antibiotics are approved to treat certain serious bacterial infections, and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems.
Source: USFDA
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.