Tuesday, June 10, 2008
Acanthamoeba Keratitis From Contact Lens Solution? FDA To Intensify Investigation While Lawyers Prepare Class Action Suits? ~by Legal Pub
Contacts are suppose to help improve one's ability to see. Multipurpose contact solution is suppose to make it more convenient for 34 million Americans to enjoy clearer vision. However, federal regulators are likely to mandate stricter testing requirements for contact lens solutions because two popular formulas have been linked to eye infections. The Food and Drug Administration is considering proposals aimed at improving the safety of solutions. But will the FDA go far enough?
New testing standards for contacts and updated labeling are likely to include instructions to gently rub lenses during the cleaning process. (Will Optometrists also be sued for not instructing their patients to do so?)
Multipurpose solutions effectiveness has been questioned since Bausch & Lomb and American Medical Optics removed their products from the market in 2006 and 2007 after an outbreak of eye infections. The Centers for Disease Control and Prevention concluded that Bausch & Lomb's MoistureLoc solution played a key role in 180 Fusarium keratitis fungal infections. (This infection can cause blindness.) Bausch and Lomb and the FDA want to ensure that the current product, Renu Multiplus, remains safe. Renu's labeling does not currently advise patients to rub their contacts. The FDA will decide if such labelling should be mandated. The FDA will also decide whether solutions should be tested against a wider range of bacteria. (Acanthamoeba keratitis is not currently among the bacteria and fungi FDA requires products be tested against.)
Dr. Elmer Tu, professor of clinical ophthalmology at the University of Illinois at Chicago, reports that infections have continued despite AMO pulling its product off the market. He believes that competing products may also be susceptible to the same type of infection. "If the outbreak is continuing and the current solutions are not working than there needs to be more research into how to reduce that risk," explains Dr. Tu.
In the mean time, T.V. ads encouraging contact wearers to contact the advertising law firm to join in possible class action lawsuits. What do optometrists have to say about potential litigation? So far, most have remained silent...