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LTW, AP

RESEARCH TRIANGLE PARK, N.C. – (NYSE: GSK) will review its labeling of the asthma drug Advair after the U.S. Food and Drug Administration issued a letter outlining changes.

The FDA’s changes center around asthma drugs that contain what are called long-acting beta-agonists, or LABAs

Advair contains the LABAs.

GSK, which maintains its U.S. headquarters in RTP, said it had 30 days in which to make the changes or state why the company disagreed.

"We will work with FDA to ensure that the final label for these products protects the interest of patients who suffer with this chronic and serious disease," said Dr. Katharine Knobil, vice president for respiratory clinical research at GSK. "It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma.”

GSK pointed out that the FDA statement does not affect Advair’s use in combating chronic obstructive pulmonary disease.

“There is no evidence from more than 10 years of data from clinical trials, observational studies and worldwide clinical experience exceeding 30 million patient-years of use that Advair is associated with an increased risk of asthma-related death, hospitalization or other serious respiratory-related outcomes in any age group,” GSK said in a statement. “There have been no asthma-related deaths in clinical trials involving nearly 18,000 patients taking Advair.”

Also on Thursday, GSK said it will remove zinc from its denture cream, following reports that excessive use over many years can cause neurological damage and blood problems in consumers.

The British manufacturer, which maintains its U.S. headquarters in Research Triangle Park, N.C., will cease manufacturing and marketing Super Poligrip Original, Ultra Fresh and Extra Care products in the U.S. The company plans to reformulate the creams without zinc. The company stressed that the products are safe when used as directed, but some patients use extra cream to help with ill-fitting dentures.

Glaxo’s voluntary action comes as hundreds of patient lawsuits are poised to go to trial, alleging Poligrip caused nerve damage, leading to a loss of balance, loss of sensation in the hands and feet, and leaving patients unable to walk.

"They made the right decision in the sense that it’s going to prevent the crippling of more people," said attorney Andy Alonso of Parker Waichman Alonso LLP. "But it’s too late for many of my clients, unfortunately."

Alonso represents more than a hundred users of denture cream in Miami federal court, where several hundred lawsuits are being consolidated. The plaintiffs say the makers of zinc-based creams failed to warn consumers about the risks of their products.

Alonso estimates about 30 million people in the U.S. wear dentures and use products like Poligrip.

Alonso estimates about 30 million people in the U.S. wear dentures and use products like Poligrip.