An FDA advisory committee met this past week to discuss labeling of anti-inflammatory eye drops used after cataract or other eye surgeries. FDA was asked to approve an increased fill size of an anti-inflammatory eye drop to allow patients undergoing two cataract extraction surgeries to treat each eye using a single bottle. At issue was whether or not these larger bottles should be approved.
FDA noted that in most cases, doctors now tell patients to use separate eye drop containers for each eye post-operatively out of fear of touch contamination and possible transfer of bacteria to the other eye. A patient who has an eye operation is at greater risk of eye infection because natural protective barriers such as the cornea are breached during surgery. While manufactured products are sterile when first opened, they can be contaminated with harmful bacteria during use. For example, the nozzle of the container might touch a patient’s eyelid or lashes.
In the end, concerns about cross contamination and the potential for infection won out. The committee eventually voted against labeling that would state that a single bottle of anti-inflammatory eyedrops could be used for two individual eyes post-operatively, even though some members did express concern that patients would always use a separate bottle for each eye, or not mix them up. FDA is now considering whether special packaging might be necessary for post-op patients who’ve had both eyes operated on, such as dual packs and bottle marked L and R (left and right).
Aside from post-operative use when patients will get fresh, unopened containers of eyedrops from a pharmacy, news of the FDA panel reminded me of a warning we issued 10 years ago to hospitals, clinics and doctor offices about sharing eyedrop containers for other purposes, too. Not just between eyes but between patients! Communal eyedrops may be used in doctors' offices and both outpatient and inpatient areas to prevent waste, control cost, and for convenience. If these should become contaminated, then patients would be at risk. Rates of contamination as high as 35 percent have been noted in some studies and, although infections are rare, they can happen and they can be devastating, even causing blindness in some cases.