Citing the dangers of potentially serious complications, the United States Food and Drug Administration (US FDA) issued a warning against the use of intraocular moxifloxacin to prevent infections following cataract surgery.
August 12, 2020, FDA advisory released sought to caution medical practitioners, most notably ophthalmologists, in administering the antibacterial medication to reduce cases of endophthalmitis.
With that in mind, learn more about the factors that prompted the advisory by discovering the potential risks involved in using moxifloxacin.
What Is Moxifloxacin And When Is It Prescribed?
Moxifloxacin is a prescription-only eye solution that’s mainly used for treating ocular infections such as bacterial conjunctivitis, more commonly known as pink or red eye. As an antibiotic medicine, moxifloxacin belongs to the fluoroquinolone antibiotics, which are used to prevent and treat certain types of bacterial infections.
How Is It Sold And Administered?
There are two major brands approved by the FDA, and they’re packaged as an ophthalmic solution, or eye drops, as previously mentioned. As such, they’re supposed to be administered by placing a few drops on your eyes.
Where Does The Problem Lie?
Some ophthalmologists use moxifloxacin and other antibacterial agents to reduce infections following cataract surgery. This condition, called endophthalmitis, has no approved oral medication, according to the US FDA. Thus, to mitigate this type of postoperative ocular infection, some health professionals thought of using moxifloxacin.
While the use of moxifloxacin as eye drops has been approved, the agency has noted that some pharmaceutical facilities have repackaged the approved ophthalmic solution to prepare them for intraocular use. Instead of topical application, the antibacterial solution would then be administered by injecting it into the eye.
Intraocular use of the ophthalmic drops hasn’t been approved by the FDA, and this was the key message of the FDA advisory. Click for more details on the unauthorized use of moxifloxacin eye solution.
Potential Risks Of Moxifloxacin Intraocular Administration
If used as an intraocular solution, moxifloxacin eye drops may trigger the following serious conditions, per the FDA’s warning:
Toxic Anterior Segment Syndrome (TASS)
Citing the Adverse Event Reporting System (AERS) database as its source, the FDA noted that 29 cases of individuals were reported to have developed toxic anterior segment syndrome (TASS) after the intraocular administration of repackaged moxifloxacin solution. The agency scoured the database up until December 29, 2019.
This condition is defined as acute inflammation of the anterior or frontal segment of the eye. It’s most often attributed to cataract surgeries and eye operations, such as keratoplasty and posterior segment surgeries. Often, the culprit for TASS includes surgical tools and equipment that had been inadvertently contaminated.
According to an updated review of TASS published in 2018, the symptoms of TASS and endophthalmitis are almost identical—blurry vision or loss of vision within 48 hours following surgery, moderate to severe eye pain, photophobia, and inflammation.
Unlike endophthalmitis, though, strong steroids instead of antibiotics are needed to address TASS more efficiently.
Retinal Cell Damage
In certain concentrations, moxifloxacin may cause damage to the retinal vascular cells, according to a study done by researchers from the Tottori University in Japan. The research also found out that other types antibiotic—namely, cefuroxime and vancomycin—caused ‘significant inflammatory effects on vascular endothelial cells’ and induced retinal toxicity. It further recommended surgeons to practice caution in injecting antibiotics into the eye.
On the part of the FDA, the threshold of moxifloxacin use hasn’t been established, but it said that intraocular use of the solution in 0.3 ml volumes and with concentrations below 0.5% isn’t likely to cause major side effects.
Are Moxifloxacin Eye Drops Safe Then?
When used as directed, an FDA-approved moxifloxacin solution is deemed safe. But as with other medication, extra precautions should be exercised in individuals who have allergies, are young or too old, and are taking other medication.
Like steroids, misuse of antibacterial drops can negatively impact the immune system. Additionally, patients using the eye drops are advised to seek immediate medical assistance when the following symptoms develop:
- Worsening eye infection
- Serious allergic reactions such as itching, rashes, difficulty breathing and swallowing, and swelling on different parts of the body
- Blurred vision
- Eye swelling and presence of whitish fluids
- Eye irritation
- Runny nose and cough
Always check with your physician if you develop these symptoms and other strange side effects.
Generally, individuals are discouraged from taking medication outside their approved uses. In the case of intraocular administration of moxifloxacin topical eye drops, healthcare practitioners are advised to know the risks involved and the potentially harmful ingredients that the solution contains.