An FDA advisory panel voted to recommend approval of a drug that could make life easier for millions of diabetics, Friday.
Exubera, an inhaled form of insulin, could reduce or eliminate the need for insulin injections to control blood-sugar levels, a grueling ritual for many with diabetes. The new drug is a powder that patients breathe in through a 6-inch inhaler.
Despite the potential benefits, several members of the advisory panel expressed concerns about the results of clinical trials showing that some patients experienced a slight drop in breathing capacity.
The decline was not found to be significant and lung function leveled off in time, but the results raised questions about how the drug would affect patients suffering from lung ailments or exposed to secondhand smoke. Some also were concerned about the possibility of malfunctioning inhalers, reports LA Times.
According to Reuters, Diabetics can prevent complications such as heart disease, blindness and amputations with a healthy diet, exercise, oral medications or insulin shots.
But many people are wary of needles and avoid taking insulin shots multiple times per day, Pfizer representatives and some panel members said.
Exubera is a short-acting form of insulin that diabetics could take before meals. Many patients still would need to take long-acting insulin by injection.
If Exubera goes to market, "this does not mean diabetics can throw away their needle and syringe," stressed Dr. Paul Woolf, the panel's acting chairman and an endocrinologist at Crozer Chester Medical Center in Upland, Pennsylvania.
Woolf voted against Exubera because he said he was not convinced patients would get adequate training in how to use the insulin inhaler properly.
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