FDA Gets Tough on Unapproved Eye Meds

The FDA is starting to crack down on drug companies that are marketing unapproved eye medication. In particular, they are focusing on companies that are marketing unapproved ophthalmic balanced salt solutions and unapproved topical drugs made with papain. Drug companies have until November 24, 2008 to stop manufacturing these products and until January 21, 2009 to have them off the market. After these dates, the FDA will take action against the drug companies.

Both of these products have been found to have serious health consequences for people who have taken them.

Ophthalmic balanced salt solutions are used during cataract surgery to irrigate the eye. Injuries stemming from the use of unapproved versions of this solution include eye inflammation, cloudy vision, and permanent loss of visual acuity. The only companies that have received FDA approval for their balanced salt solutions are Alcon and Akorn.

Topical drug ointments made with papain have been used for the purpose of removing dead or contaminated tissue in acute and chronic lesions. Unapproved versions of this product have been found to cause hypersensitivity reactions resulting in low blood pressure and rapid heart rate. The FDA has approved this product from the following companies: Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox.

If you are considering eye surgery to correct your vision problems, you can use the links at the bottom of this page to find a qualified ophthalmologist in your area.