Warning Suggested for Contact Solutions
FDA Advisory Panel Recommends Infection Warnings for Contact Lens Solutions
June 10, 2008 -- Experts on Tuesday backed new warnings and stricter testing for contact lens solutions used by millions of consumers. The recommendations come in the wake of infection outbreaks that caused product recalls and alarm among patients.
The recommendations of an FDA advisory panel are likely to lead to strong new warnings on multipurpose contact lens solutions. The FDA is considering alerting consumers not to reuse the solutions and to thoroughly rub and rinse contacts when removing them.
The agency is also considering warning consumers not to wear lenses during water activities like swimming or showering. And it is planning to revamp its requirements for the way companies prove their solutions are safe and effective before selling them.
Experts told FDA officials to strongly caution patients that reusing multipurpose lens solution can foster infections that can lead to blindness.
"It needs to be a strong warning," said Neil M. Bressler, MD, a professor of ophthalmology at the Wilmer Eye Institute in Baltimore and the chairman of an FDA advisory panel that met here Tuesday.
Outbreaks of Eye Infections
The proposed warnings stem from a pair of eye infection outbreaks in 2006 and 2007. One outbreak, which began in May 2006, caused a dangerous infection known as Fusarium keratititis in at least 130 patients nationwide.
Fusarium is fungus that can cause aggressive eye infections, potentially leading to blindness. Nearly one-third of the infected patients had to undergo corneal transplants, FDA officials said.
The outbreak also led to the recall of a popular contact lens solution called ReNu MoistureLoc. The solution, made by Bausch & Lomb, was thought to be at the root of most cases.
At least 158 people were sickened by a second outbreak in the spring of 2006, this one caused by a waterborne parasite called Acanthamoeba. The illnesses led to the recall of another brand, Complete MoisturePlus Multipurpose Solution made by Advanced Medical Optics.
Researchers found that the disinfecting solution failed to kill the amoeba, leading to calls for the FDA to enforce stricter testing requirements on manufacturers. Experts on Tuesday endorsed FDA plans to require companies to test solutions for their ability to kill Acanthamoeba.
But despite the apparent failure of the solutions, widespread unsafe practices by millions of contact lens wearers also appear to be to blame, experts said.
Bernard Lepri, an FDA safety official, said studies have found that up to 90% of regular lens wearers don't comply with basic instructions like avoiding reuse of solution and letting tap water touch lenses, and also always washing hands before touching lenses.
"We see that even though procedures are simple and minimal, noncompliance can still be quite high," he said.
Experts urged the FDA to issue new guidance encouraging patients to always "rub and rinse" their lenses before soaking them. Some studies suggest the method reduces bacteria and debris on lens surfaces, though researchers still don't know how well it prevents infection.
"Rinsing works somewhat, rubbing works even better, having both works best of all, and doing neither works worst of all," said Timothy McMahon, a professor of optometry at the University of Illinois, Chicago, and a member of the panel.