Diabetes Inhaler Testers Get Cancer, FDA Warning Issued
Persons who use an Exubera® inhaler to control high blood sugar, or who are thinking of using this product, should definitely consider an alternative form of treatment. This is especially important now that six cases of lung cancer have been reported in persons who participated in clinical trials of the product.
Exubera is a drug made by the pharmaceutical company Pfizer, Inc. When it came on the market approximately two years ago, it was approved by the U.S. Food and Drug Administration and hailed as the first new delivery system in some 80 years: “Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition,” said Dr. Steven Galson, Director, Center for Drug Evaluation and Research, FDA, in January 2006 when Exubera was approved. It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugar.”
Now, however, in light of six cases of diagnosed lung malignancies among participants in the clinical trials, the FDA has issued a safety alert on the product. Pfizer, in turn, has sent appropriate letters of warning to healthcare providers and to persons known to be using the product. In addition to the six malignancies reported on test victims, one more case of cancer has been reported by a user following the release of Exubera.
The drug had been approved to treat the two major types of diabetes – Type 1 and Type 2. Persons with Type 1 produce virtually no insulin, and Type 2 victims do not produce enough insulin to control their blood sugar levels. Exubera is delivered in a powdered form using a special type of inhaler.
Some 2,500 persons were involved in the clinical testing of Exubera. While seven cases of cancer have developed and a warning about the product issued, the FDA backpedaled on banning the drug. There are too few cases of cancer to determine whether the emergence of these events is related to Exubera, the warning letter said. It also pointed out that all of the cancer victims had been smokers earlier in their life.
On the other hand, the FDA considers it wise for healthcare providers to prescribe a different product than Exubera. “Because of the limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients’ glycemic control. (Glycemic control refers to maintaining proper blood sugar levels following ingestion of carbohydrates.)
As previously stated, safety alert letters have been sent by Pfizer, Inc. to healthcare providers and to users. While these letters maintain that Exubera remains a safe and approved treatment, healthcare providers and Exubera users would be wise to follow the FDA warning and “seek alternative options.”