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.
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.
Mar 31, 1998
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