FDA asks Allergan to withdraw eye drug sales aid

WASHINGTON (Reuters) – The Food and Drug Administration has
asked Allergan Inc. to withdraw promotional material for its
Lumigan eyedrops to treat glaucoma because the sales aid is
misleading, according to a letter made public on Thursday.

In the letter dated September 6, the FDA says the
promotional material makes “unsubstantiated superiority claims”
for Lumigan over other medications and treatments.

The agency also said it was concerned that Allergan
continues to promote Lumigan in a “violative manner” and
referred to a 2001 warning sent to the company over similar
issues.

Glaucoma is a disorder in which pressure in the eyeball
increases, damaging the optic nerve and causing vision loss.

The FDA asked for a written response, on or before
September 20, stating whether Allergan intends to comply with
the request, listing promotional materials in violation, and
providing a plan for discontinuing use of the materials.

The letter also requests a comprehensive plan to distribute
corrected messages to audiences who received the sales aid.

An Allergan spokeswoman said the company was seeking
clarification from the FDA and would be working closely with
the agency to address the matter “in the next few days.”

Lumigan’s FDA-approved labeling says the drops are for
reducing elevated pressure in patients with open angle glaucoma
who are intolerant or unresponsive to other pressure-lowering
medications.