What is the FDA Warning on Artificial Tears?

Artificial tears are a common over-the-counter (OTC) medication used to relieve dry eye syndrome. It is estimated that 5-30% of the global population experiences symptoms of dry eye syndrome, including irritation, redness, and a gritty sensation in the eyes. Artificial tears are designed to mimic natural tears and provide temporary relief to dry and irritated eyes. However, the FDA has recently issued a warning regarding the use of artificial tears. This article will provide an overview of the FDA warning on artificial tears, the potential risks associated with them, and the steps that consumers can take to ensure their safety.

What is the FDA Warning on Artificial Tears?

In May 2021, the FDA issued a warning regarding the use of certain OTC eye drops containing benzalkonium chloride (BAK), a common preservative used in many artificial tears. The warning highlighted the potential risks associated with long-term use of these eye drops and recommended that consumers be aware of the risks before using them.

The warning specifically targets those with glaucoma, a condition that damages the optic nerve and can lead to blindness. Research has shown that long-term use of BAK-containing eye drops can exacerbate the effects of glaucoma and increase the risk of developing the disease. The FDA recommends that those with glaucoma use BAK-free eye drops or speak to their healthcare provider before using BAK-containing eye drops.

Potential Risks Associated with Artificial Tears:

Aside from the potential risks associated with BAK-containing eye drops, there are several other risks that consumers should be aware of when using artificial tears. These risks include:

  1. Contamination: Artificial tears are typically stored in a multi-dose bottle that can become contaminated with bacteria over time. This can lead to eye infections and other complications.
  2. Allergic Reactions: Some individuals may be allergic to the ingredients in artificial tears and experience an allergic reaction when using them. Symptoms of an allergic reaction may include redness, itching, and swelling of the eyes.
  3. Masking Underlying Conditions: Artificial tears can provide temporary relief from dry eye symptoms, but they do not address the underlying cause of the problem. In some cases, dry eye syndrome may be a symptom of an underlying condition that requires medical attention.

How to Ensure the Safe Use of Artificial Tears:

Despite the potential risks associated with artificial tears, they can be a safe and effective way to relieve dry eye symptoms when used properly. Here are some steps that consumers can take to ensure the safe use of artificial tears:

  1. Read the Label: Always read the label before using any OTC medication, including artificial tears. Pay close attention to the active ingredients, potential side effects, and any warnings or precautions.
  2. Follow Instructions: Use artificial tears as directed on the label or as instructed by your healthcare provider. Do not use them more frequently than recommended or for longer than instructed.
  3. Store Properly: Store artificial tears according to the instructions on the label. Most artificial tears should be stored at room temperature and discarded after a certain period of time, even if there is still some liquid remaining in the bottle.
  4. Use Single-Use Vials: Consider using single-use vials of artificial tears instead of multi-dose bottles to reduce the risk of contamination.
  5. Speak to Your Healthcare Provider: If you have any questions or concerns about using artificial tears, speak to your healthcare provider. They can help you determine the best course of treatment for your specific needs.