Allergan Alphagan

Executive Summary

Promotional materials claiming that visual fields were unchanged or improved in 95% of Alphagan (brimonide tartrate ophthalmic solution) treated patients are "inconsistent with the approved product labeling and constitutes an unapproved new use," FDA says in an April 15 letter. "Alphagan is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, not for the preservation of visual fields." In addition, the Allergan tagline "The Drop Without the Downside" is misleading, FDA says, because it implies that the product does not have side effects. "However, Alphagan has numerous precautions, adverse reactions and contraindications in its approved product labeling such as the precaution regarding the potential for a decrease in mental alertness for patients who may engage in hazardous activities," the agency notes