FDA Enhances Warnings on Fluoroquinolone Antibiotics
On July 26, the U.S. Food and Drug Administration (FDA) bolstered the warnings concerning a certain class of antibiotics, called fluoroquinolones, saying they’re too strong for bronchitis, sinus infections, and simple urinary tract infections.
The following drugs are all fluoroquinolone medications. There are more than 60 generic versions of fluoroquinolones.
- Levofloxacin (Levaquin)
- Ciprofloxacin (Cipro)
- Ciprofloxacin extended-release tablets
- Moxifloxacin (Avelox)
- Ofloxacin
- Gemifloxacin (Factive)
- Delafloxacin (Baxdela)
These drugs are associated with serious and long-lasting side effects.
A good friend of mine suffers from permanent neuropathy in her hands as a result of taking Cipro several years ago.
The FDA said in a statement:
“While these drugs are effective in treating serious bacterial infections, an FDA safety review found that both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system.
These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.” [1]
Two or more of these side effects can occur together. [2]
Fluoroquinolone injuries are so common, in fact, that victims of the antibiotics refer to themselves as “floxies.” The name comes from ciprofloxacin.
Read: The Dangers of Fluoride-Based Antibiotics, Plus Natural Solutions
Fluoroquinolones are associated with a slew of mental health side effects, including:
- Pain in the tendon, joints, or muscles
- A sensation of “pins and needles”
- Confusion, disorientation, or delirium
- Hallucinations
- Tendon ruptures
- Disturbances in attention
- Agitation
- Nervousness
- Memory impairment
Some studies link fluoroquinolones with dissection (tears) and aneurysms (bulging or enlargement) of the aorta. Both conditions can cause the aorta to weaken, causing it to burst. [4]
The agency stated that fluoroquinolones should only be used for serious bacterial infections, such as anthrax, plague, and bacterial pneumonia. In such cases, the FDA said that:
“the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option.”
The new labeling action will include an updated boxed (“black box”) warning and revisions to the Warnings and Precautions section of the label. Patients who purchase one of these antibiotics will also receive a medication guide describing the safety issues associated with fluoroquinolones.
The FDA first slapped a boxed warning on fluoroquinolones in July 2008 to inform consumers that the drugs have the potential to cause tendinitis – inflammation of the tissues that connect muscles to bones. [3]
Three years later (2011), the FDA warned that fluoroquinolones could exacerbate symptoms of the neuromuscular disease myasthenia gravis. In 2013, the agency detailed the potential for serious nerve damage – irreversible peripheral neuropathy, like my friend has. [2]
Then, in 2015, an FDA advisory committee said that uncomplicated sinus, urinary, and bronchial infections should be treated using other options.
July 2018 Update: FDA Adds Blood Sugar Drop Warning
On July 10, 2018 the FDA ordered that even stronger safety warnings be added to fluoroquinolones.
The new warnings will inform patients about the drugs’ potential to cause dangerous drops in blood sugar and neurological side effects, including delirium and memory problems.
ward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release:
“The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option.
The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that healthcare providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use.”
The agency said it was requiring the new warnings based on “a comprehensive review of the FDA’s adverse event reports and case reports published in medical literature.”
The new warnings will require that these side effects be listed separately from other central nervous system side effects and be consistent across the labeling of the fluoroquinolone class.
The agency goes on to say in the release that the recent review “found instances of hypoglycemic coma” after patients took fluoroquinolones. The new warnings will also make mention of this risk.
December 2018 Update: Increased Risk of Heart Vessel Tears
On December 20, the agency yet again warned about a new threat associated with fluoroquinolone antibiotics, warning of an increased risk of heart vessel tears.
In a statement, the agency said:
“These tears, called aortic dissections, or ruptures of an aortic aneurysm, can lead to dangerous bleeding or death.”
The antibiotics pose a risk of aortic dissection whether given in injection or pill form and “should not be used in patients at increased risk unless there are no other treatment options available.”
Those at increased risk include people with a history of blockages or aneurysms of the aorta or other blood vessels, those with high blood pressure, patients with certain genetic disorders involving blood vessel changes, and the elderly, the FDA said.
Before taking an antibiotic, patients should notify their doctor if they’ve been diagnosed with:
- Aneurysms
- Hardening of the arteries (atherosclerosis)
- High blood pressure
- Genetic conditions, such as Marfan syndrome and Ehlers-Danlos syndrome
People already taking fluoroquinolones shouldn’t stop taking the antibiotics without first talking to their doctor.
Sources:
[1] NBC News
[2] WebMD
[3] Reuters
[4] Drugwatch
(Article featured image only a representation of fluoroquinolones.)