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| KATHRYN GAGLIONE / Scroll |
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Of the near 21 million Americans who have diabetes, 5 million take insulin. The majority of those with Type II diabetes have uncontrollable blood sugar levels. Since the discovery of diabetes 90 years ago, diabetes sufferers have injected insulin, an effective proven treatment, in order to regulate blood sugar levels.
Now, Pfizer has created a solution for all those who are fearful of needles and shots — Exubera. On Jan. 27, the FDA approved Exubera, a type of insulin that is inhaled instead of injected.
Although not approved for children under the age of 18, Exubera provides short-acting insulin in powder form via an inhaler. According to Pfizer, the inhaler weighs four ounces and is about the size of an eyeglass case. A retractable tube comes out of the device and extends from the chest to the mouth. Users insert a blister pack before triggering the device.
“I have been taking insulin since I was two and a half years old and I got an insulin pump on my mission,” said Jon Porter, a freshman from Centerville, Utah. “I think the new device would be a little more awkward than the pump I’m using now.”
However, others believe the insulin will provide a more convenient way to take insulin.
“Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition,” said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, in a news release. “It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.”
The FDA has required that the manufacturers of Exubera distribute a medication guide along with the product. The guide outlines FDA-approved information especially for patients.
Exubera is not to be used by smokers or people who have quit smoking within the last six months. It is not recommended for patients with asthma, bronchitis or emphysema. However, the FDA suggests that people with the flu or colds should continue taking the drug, even though it may induce coughing.
The FDA also recommends that patients get their lungs tested for good function before taking Exubera. These tests should be repeated every 6 to 12 months during treatment.
Diabetes is a serious condition and Pfizer has been working on Exubera for the past 10 years. Following a 7-2 vote for the approval of Exubera, the FDA advisory panel — in a 5-4 vote — called for long-term studies to confirm its safety.
Although the product has been approved for Type 1 and Type 2 diabetes, tests have shown that less than 30 percent of type 1 diabetes patients had reduced blood sugar levels after six months of use.
