Inhaled Insulin Might Not Discourage FDA Advisory Committee

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A new and exciting possible treatment for diabetes has been on the horizon for several months now. “Exubera,” an inhaled type of insulin is meant to provide diabetics with a needle-free way of getting their insulin medication. Since both children and adults alike hate needles, this is a potentially great way to encourage patients to treat their diabetes sufficiently.

With the recent vote in favor of this new drug by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, this drug may become a reality very soon. However, the recommendation for approval of this drug comes under stipulations that Pfizer, the makers of Exubera, continue tests into the long-term safety of this drug. These tests may extend almost into the year 2020.

An important issue at hand involves the fact that the drug has to be taken into the lungs, so the effects of it on the pulmonary system need to be evaluated carefully. This is significant, as the FDA has been under a lot of heat lately for the high number of drug withdrawals that have been occurring as of late — and questions regarding the safety of newly approved medication.

Because trials based on the inhaled drug have shown that it may cause coughing and slightly reduced lung capacity, the FDA has to really consider whether or not the benefits outweigh the risks. The mild side effects are also bringing up questions of how safe this drug would be for smokers and people with lung disease. Tests on patients with such health concerns may need to be performed in the near future in order to accurately determine the safety of the drug.

However, the drug has been shown to have as much of an actual impact on controlling blood sugar levels as injections. This fact will undoubtedly increase its appeal. Another thing that needs to be considered is that many cases of Type 2 diabetes can be treated with pills and therefore do not require injections. However, many people with Type 2 diabetes do need to use needles, as do all patients with Type 1 diabetes, which is also called “juvenile onset diabetes.”

This, of course, creates mass appeal for the inhaled drug, as children are even more commonly afraid of injections than adults are. Still, the inhaled drug couldn’t replace injections required before bed, only those needed before meals. Regardless, this drug is now on the table — and it is being recommended for public sale. However, it is the FDA’s final decision to consider the approval request for Exubera or to disregard it.

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Dr. Victor Marchione, MD

About the Author, Browse Victor's Articles

Victor Marchione, MD received his Bachelor of Science Degree in 1973 and his Medical Degree from the University of Messina in 1981. He has been licensed and practicing medicine in New York and New Jersey for over 20 years. Dr. Marchione is a respected leader in the field of smoking cessation and pulmonary medicine. He has been featured on ABC News and World Report, CBS Evening News and the NBC Today Show and is the editor of the popular The... Read Full Bio »