ABSTRACT

In 1994, animal experiments showed the sensitizing capacity of amlexanox to be comparable to that of p-phenylenediamine and DNCB, which are very strong contact sensitizers in man as well as in experimental animals. A 23-year-old woman with allergic conjunctivitis had been treated with 0.25% amlexanox ophthalmic solution for 11/2 year, when she woke up with itchy redness around eyes. The authors of ref. 6 mention that 'many cases of contact dermatitis from amlexanox 0.25% ophthalmic solution have been reported' and cited 6 Japanese literature references from 1990 and 1991 describing at least 13 sensitized patients, including a series of three and one of four. A 23-year-old woman with allergic conjunctivitis had been treated with 0.25% amlexanox ophthalmic solution for 11/2 year, when she woke up with itchy redness around her eyes. The ingredients of the product were tested separately, and the patient reacted to amlexanox 1%, 0.25%, 0.1% and 0.025% water and to 1% and 0.25% pet.