Published on the Packaging World Web site
| March 31, 1998
Eye drug warnings
Labels of popular OTC eye allergy relief drugs such as Pfizer's Visine, Ross Labs' Murine Tears Plus and Clear Eyes ACR, Bausch & Lomb's Sensitive Eyes, and other vasoconstrictor drugs containing ephedrine, naphazoline, phenylephrine, and tetrahydrozaline should include the warning "Pupils may become dilated (enlarged)," according to an FDA proposal.
The agency also is considering whether additional words such as "This is temporary and not serious" would be beneficial. FDA said it has received a number of complaints about dilated pupils and hoped the warning would reduce the number of adverse incidents. FDA is also proposing that product labeling requirements for these products be amended to read "If you have narrow-angle glaucoma do not use this product except under the advice and supervision of a doctor." Currently the warning applies to those having glaucoma of any type.
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