Common questions about Exubera (FAQ)
Q: When was Exubera first approved by the FDA?
Exubera was approved for use in the USA by the U.S. Food and Drug Administration (FDA) and simultaneously in the European Union by the European Medicines Agency (EMA) in January 2006.
Q: Why was Exubera taken off the market?
Exubera was voluntarily withdrawn from the global market by the manufacturer in 2007. Official reports state that this decision was based on low commercial sales and lack of consumer demand, and was not triggered by new safety concerns cited in the product withdrawal notice.
Q: Is Exubera still prescribed by doctors anywhere in the world?
No. Exubera was withdrawn from the U.S. market in 2007 and globally by the manufacturer shortly thereafter. It is no longer available by prescription anywhere in the world.
Q: What is the difference between Exubera and standard subcutaneous injections?
The primary difference is the method of delivery: Exubera delivered insulin as a dry powder via oral inhalation through the lungs, unlike standard liquid insulin delivered under the skin via injection. The inhaled route required mandatory periodic lung function monitoring, which is not associated with subcutaneous insulin.
Q: Can Exubera be used as a person's only medicine for their condition?
According to regulatory documents, the usage depended on the type of diabetes. For adults with Type 2 diabetes, Exubera could be used alone or with other medicines. However, the label specified that for adults with Type 1 diabetes, it must be used along with a longer-acting (basal) subcutaneous insulin.
Q: Does Exubera contain lactose or other common allergens?
The dry powder containing the insulin also contained excipients, which are non-active ingredients, such as mannitol, glycine, and sodium citrate. The full list of inactive ingredients is available in the official product label for review.
Q: What kind of cough is common with Exubera use?
Official product information indicates that an increased cough is a common side effect of Exubera. This cough is generally described as mild to moderate and may be accompanied by a dry mouth or some chest discomfort. In clinical trials, it rarely led to treatment discontinuation.
Q: Are there any long-term effects on the lungs associated with Exubera?
Studies and official warnings noted that treatment was associated with a small, but persistent, decline in a lung function measure called Forced Expiratory Volume in 1 second ( FEV1). This change was nonprogressive while on therapy and was generally found to reverse once a person stopped using Exubera. Regular lung function testing was a mandatory safety requirement throughout treatment.
Q: Can Exubera cause weight gain or weight loss?
Insulin therapy, including Exubera, is generally associated with the potential for weight gain, which is a known effect of treatment. Clinical trials routinely monitored changes in body weight as part of the overall safety and efficacy evaluation.
Q: What are the signs of a severe allergic reaction to Exubera?
Signs of a serious, life-threatening allergic reaction (anaphylaxis) can include hives or a rash across the body, shortness of breath, wheezing, and a fast pulse. Official safety information indicates that such reactions are considered medical emergencies.
Q: Are headaches a common side effect of Exubera?
Headaches are specifically listed in the official documents as one of the common signs and symptoms of low blood sugar (hypoglycemia). Low blood sugar is the most frequent adverse effect associated with Exubera and all insulin treatments.
Q: Does Exubera have any warnings about use in children under 18?
Official product information states that Exubera was not recommended for use in patients under 18 years of age. This recommendation was based on the fact that the long-term safety of inhaled human insulin had not been established in the pediatric population.
Q: Can Exubera be used during pregnancy, according to official documents?
There were no adequate and well-controlled studies involving Exubera use in pregnant women. Regulatory documents emphasize that careful glucose control is essential during pregnancy, and any decision regarding its use was based on a clinical assessment of risk versus benefit.
Q: Is Exubera use limited for people over the age of 65?
Regulatory experience with inhaled insulin was noted to be limited in patients 75 years of age and older. Because of this limitation in clinical data, its use in this older population was not recommended in certain European regulatory documents.
Q: Is there a Black Box Warning associated with Exubera?
The original FDA label for Exubera did not contain a Black Box Warning, which is a specific type of serious warning. However, the label did carry strong warnings and contraindications for specific patient groups, such as people who smoke and those with unstable lung disease.
Q: Are there known drug interactions between Exubera and blood pressure medicines?
The official product label specifically noted an interaction with Beta-2 Agonists, a class of drug sometimes used for respiratory or blood pressure conditions. Co-administration of these drugs could potentially increase the systemic absorption of Exubera.
Q: What happens if Exubera is taken with alcohol?
According to the official product information, alcohol can alter the way insulin works and affect how the body controls blood sugar levels. This effect may increase the risk of developing low blood sugar (hypoglycemia).
Q: What was the main outcome of the clinical trials for Exubera?
Clinical studies demonstrated that Exubera provided a level of glucose control, measured by the long-term marker HbA1c, that was comparable to conventional rapid-acting injectable insulin regimens. This was observed in trials involving people with both Type 1 and Type 2 diabetes.
Q: Is there a long-term follow-up study required for people who used Exubera?
The safety profile for Exubera required mandatory monitoring. This included lung function testing ( FEV1) before starting therapy, at six months, and annually thereafter, for the entire duration of treatment.
Q: Were studies on Exubera stopped due to safety concerns?
Official records indicate that some long-term extension studies were terminated early in 2007. This termination was not driven by new safety concerns, but rather was a direct consequence of the manufacturer's commercial decision to withdraw the product from the market.
Q: Does Exubera need to be stored in the refrigerator?
The unit-dose powder blisters were required to be stored at room temperature. Regulatory information specified that the product should be kept away from excessive heat, air, and moisture to maintain stability.
