July 6, 2014
FDA Approves Afrezza to Treat Diabetes
With everyone going ga-ga over FDA approving Afrezza, I have some serious doubts about how many people will be able to use it. I know that I will not be one of them. This is because of one thing – I would have difficulty getting the correct dose into my system because of sinus problems which can occur anytime and make breathing difficult. When this happens, I am forced to breath through my mouth.
This is not one of the problems even listed, but if you have this problem, getting the mist into your lungs may be difficult. Afrezza has a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
With the above information, I would also be concerned about people with diabetes that develop pneumonia. In addition, nothing is mentioned about any testing for the elderly. People at all ages can have respiratory problems causing breathing problems and often the necessity for oxygen use. From the way drug reps promote drugs and doctors prescribe, I can see patients with respiratory problems being prescribe Afrezza. To me it seems that the FDA has missed some information and at a minimum left their brains at home when they approved Afrezza.
Afrezza is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke. Even then it was approved and it will work for some people and that is a good thing. At least the FDA is requiring some post-marketing studies for Afrezza. These studies include a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric (young people under the age of 19) patients. The second study is a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza. This trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function.
Two additional trials have been ordered. They are pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response, and one to characterize within-subject variability. Both are important and hopefully will help regulate the dosage on an individual basis.
I would hope that individuals with any of the problems mentioned above would hesitate before letting the doctor prescribe it for them. Let the people with diabetes without significant health problems be the ones to find out if Afrezza works for them.