FDA Mandates New Warning Label for Serious Mental Health and Hypoglycemic Side Effects of This Drug

The US Food and Drug Administration (FDA) has announced that fluroquinolones, a class of antibiotics, needs better labeling that more clearly identifies the risk of serious mental health side effects as well as the risk of low blood sugar leading to hypoglycemic coma. The call for a label change was spurred by findings from a new safety review.

Fluroquinolones are an antibacterial medicine that work to kill or stop the growth of bacteria that cause serious illnesses, like bacterial pneumonia. Drugs of this type have been used for more than 30 years. More common side effects of the drugs include nausea, diarrhea, headache, dizziness, and trouble sleeping. There are currently mental health side effects listed in the “Warnings and Precautions” section of the labels, but they differ depending on the version of the drug.

Photo: AdobeStock/diego cervo
Photo: AdobeStock/diego cervo

Drugs in the fluoroquinolone class include:

  • Avelox (moxifloxacin)
  • Baxdela (delafloxacin)
  • Cipro (ciprofloxacin)
  • Cipro extended-release (ciprofloxacin extended-release)
  • Factive (gemifloxacin)
  • Levaquin (levofloxacin)
  • Ofloxacin (generic)
  • (Some other generic brands available)

The New Labeling

The new labeling requirements call for more clarity and consistency. All drugs in the fluoroquinolone class will be required to have a separate list of mental health side effects (apart from the central nervous system side effects) labeled “Psychiatric Adverse Reactions” that includes disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium. The new requirements also call for a “Blood Glucose Disturbances” section on the labels that will explicitly note the risk of hypoglycemic coma—previous labels only noted a risk for blood sugar fluctuations.

Photo: AdobeStock/JJAVA
Photo: AdobeStock/JJAVA

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Why The Change?

The FDA reviewed data on adverse events associated with the use of fluoroquinolones over a 30-year-period. In that time, there were 67 reports of hypoglycemic coma. Most of those cases had hypoglycemic risk factors like advanced age, diabetes, or concurrent use of hypoglycemic drugs like sulfonylureas. Out of the 67 reported hypogylycemic comas, 13 resulted in death, and nine resulted in a permanent disability.

The same review found a range of psychiatric adverse reactions associated with the drug that justified stricter labeling. The drug labels already included some psychiatric side effects like hallucination, psychoses, confusion, depression, anxiety, and paranoia. Now all labels will include at least the mental health risks described above (disturbance in attention, etcetera) and be “more prominent and more consistent.”

Photo: AdobeStock/underdogstudios
Photo: AdobeStock/underdogstudios

Already Included Side Effects

This is not the first time that fluoroquinolones have been subject to added warnings. Over the years, the FDA has also mandated the labeling of other risks:

  • 2008: Warning for increased risk of tendinitis and tendon rupture
  • 2011: Warning for risk of increased symptoms for those with myasthenia gravis
  • 2013: Warning for risk of irreversible peripheral neuropathy
  • 2016: Warning for risk of permanent side effects to tendons, muscles, joints, nerves, and central nervous system
Photo: AdobeStock/khwaneigq
Photo: AdobeStock/khwaneigq

What Does the FDA Recommend?

First and foremost, the FDA recommends to both doctors and patients that fluoroquinolones should only be used in severe cases when no other treatment options are available. For those for whom no other option is available, the FDA recommends that patients and doctors discuss how to identify and treat low blood sugar. If patients experience serious symptoms of low blood sugar such as confusion, inability to complete simple tasks, blurred vision, or seizures, they should call 911. Risk factors for low blood sugar, like diabetes or diabetes medication, should be understood and discussed thoroughly.

All patients prescribed a fluoroquinolone medication should receive a patient medication guide, and patients should familiarize themselves with its contents.

Photo: AdobeStock/JJAVA
Photo: AdobeStock/JJAVA

All medication decisions should be made with the guidance of a doctor. There are times when the benefits of a medication outweigh the risks. Because people with diabetes are already at risk for depression, neuropathy (nerve damage), and hypoglycemia, doctors should consider carefully the pros and cons of this drug. As always, warning labels on medications should be taken seriously and all dosage instructions should be carefully followed.

Stay healthy, friends.

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