FDA Panel Votes in Favor of Inhalable Insulin; Diet Drug Recalled

FDA Panel Votes in Favor of Inhalable Insulin
On April 1, a US Food and Drug Administration (FDA) advisory panel voted in favor of Afrezza, an inhalable insulin/inhaler combination, for the treatment of Type 1 and Type 2 diabetes in adults.

Afrezza is comprised of a premeal insulin powder and a whistle-size device that the powder is loaded into for inhalation. MannKind Corporation, the developer, is seeking approval for the product as an ultrarapid-acting insulin treatment for adults with Type 1 or Type 2. In those with Type 1, the insulin would be for use along with injected basal (background) insulin.


The Endocrinologic and Metabolic Drugs Advisory Committee voted 13-1 in favor of Afrezza for Type 1 diabetes and 14-0 for Type 2 diabetes. Members noted the benefits of the insulin’s rapid onset of action and short duration, which lowers the risk for low blood glucose, and also cited the potential advantages of inhalable insulin for people with Type 2 who may not wish to or be able to give themselves injections.

The panel members did, however, express concerns about data indicating the inhalable medicine is less effective at lowering blood glucose in people with Type 1 compared to short-acting injectable insulin. They also noted the lack of long-term information on the drug’s effects on lung function and lung cancer risk. The panel made recommendations to the FDA for labeling requirements and postmarketing studies to address these concerns.

“My greatest concern is related to the cancer risk, and I think the way I saw the data, the efficacy of this was not as good as [injectable] insulin,” noted panel member David Cooke, MD. But “the convenience and desirability of avoiding injections and ease of use and all the hurdles that injections impose upon diabetics” are an “unambiguous benefit,” he added.

Exubera, an inhalable insulin approved in the United States in 2006, was discontinued by manufacturer Pfizer in 2007. The drug’s high price and bulky inhaler, along with concerns about lung function, led to much lower sales than expected.

The FDA is not required to follow the advice of its advisory panels, but it typically does. The agency is expected to make a final decision on Afrezza by April 15. (Editor’s note: As of April 7, the FDA has pushed its review date back by three months. The agency is now expected to make a decision on July 15.)

For more information, read the articles “FDA Panel Says Yes to Inhaled Insulin Device” and “FDA Advisory Panel Endorses Inhaled-Insulin Product Afrezza.”

Diet Drug Recalled
On March 27, pharmaceutical manufacturer GlaxoSmithKline (GSK) Consumer Healthcare voluntarily recalled all nonprescription supplies of the weight-loss drug alli (generic name orlistat) from retailers in the United States and Puerto Rico due to tampering concerns.

Alli capsules are a turquoise-blue with a dark blue band that has the text “60 Orlistat.” GSK said consumers have reported buying bottles of alli containing a “range of tablets and capsules of various shapes and colors.” Some of the bottles were also missing labels and had inauthentic tamper-evident seals. Authentic bottles of the medicine are labeled and have an inner foil seal with the words “Sealed for your Protection.”

“We have received reports of about 20 bottles purchased by 12 consumers in seven states: Alabama, Florida, Louisiana, Mississippi, New York, North Carolina, and Texas,” noted senior external communications manager Deborah Bolding.

Bottles with the following lot numbers and expiration dates have been reported to contain a product other than alli: 14372, February 28, 2016; 14395, February 28, 2016; 14124, September 30, 2015; 14267, January 31, 2016; 14442, April 30, 2016.

Consumers are advised not to use alli they have purchased if they are unsure or concerned about whether it is authentic. They are asked to call GSK at (800) 671-2554 to speak with a representative. People who have consumed any questionable product should contact their health-care provider.

For more information, see myalli.com.

  • Bonnie Lu Brehm

    I took the last inhaler insulin even though I was not suppose to because of my asthma, but since the asthma doctor gave me diabetes 2 they allowed it.

    It was great and I was very disappointed when the company took it off the market because “they weren’t making that much money on it”. Hello, you don’t get it do you, over 12 million Americans and then some are diabetic already, pretty soon you might as well say we all are. How can the companies not get rich.

    If the FDA approves this inhaler and my insurance pays for it I will go on it immediately. I hate these friggin needles.

  • Joe

    Personally, I hate using an inhaler for anything. I never feel like I’m getting anything past my tongue. Todays insulin needles are so fine I can’t feel them. It’s not a product I would care to use.

    The situation with alli , on the other hand, is frightening. I can understand problems like this if you’re buying from overseas or dealing with an online pharmacy -counterfeit drugs are common and you take your chances- but these sound like they came from the GSK factory tampered with, or were altered while in the normal supply chain. That could happen to any product, even if you buy it from a reputable pharmacy.

    I know there are laws protecting food products from adulteration during distribution. I would assume something similar is in place for pharmaceuticals. People need to demand to be told what went wrong and not just let this story fade away.

  • Peggy Mason

    I already take Humalog insulin with 2 shots a day, once in the morning and once in the evening. I would be willing to try the enhaler if it works for me.

  • Pat Weiser

    I would be thrilled to try an inhaled insulin. I need so many different shots a day, Lantus, Victoza and Humalog for breakfast just to start, my stomach and legs are getting hard and I have trouble finding a good spot anymore.

  • Peggy Boatright

    Yes, I would.

  • Dr G V Rao

    I am declared Diabetic. I have been advised to take “8” units of insulin injection every night before sleep. Now I am very happy to hear that an insulin inhaler has come and I wish to avail this opportunity to have it. I am resident of India but I am visiting USA in May this year and If I come to know the product availability in NJ I shall purchase it and use it. Simultaneously If it is available in India Kindly let me know.
    Thanking you
    G V Rao

  • Theresa

    My mother should be on insulin, but is terrified of needles. An Inhaler would be great for her and even for myself. You can only inject yourself so much.

  • PhilBB

    I would take more smaller amounts of insulin perhaps if I could sniff it. I do take insulin and have been injecting it for 45 years.

  • shanks

    Administering insulin through an inhaler does not sound right as a 100% effective drug delivery procedure. Insulin administered through injectible devices makes sense because the insulin is delivered directly through the blood circulatory system. Also one assumes that a substantial quantity of the inhalable insulin, supposed to be delivered through the pulmonary system would also find its way into the digestive system. Would it therefore mean that, against say a normal dosage of 20 units, the patient would have to inhale 40 units? What a waste. Also, what could be the harmful effects of insulin on the digestive tract? Maybe, if well informed on these and other important questions, inhalable insulin could be worth trying – will be a refreshing departure from painful injections.


    ANY MODALITY THAT CAN INHANCE UPTAKE of insulin, and bypass the digestive tract and eliminate, the risk of infection due to the use of needles, is a win -win !

  • Dr Ijaz Ahmed

    It would be great blessing for the diabetic people . Because naturally no one wants to take injections four times a day.howeverits price should be affordable for every one.

  • Patricia Lorenz

    Yes I would love to stop taking shots ! Same goes for my 92 yr old Father-in- law !

  • serap

    Yes most deffinately. My daughter cries everyday for the past 3 years because she hates the needles. Its very stressful. Please keep me updated. Thank you.

  • Dennis Austin

    I believe this product certainly would stop at least some of my shots. It can be a pain at times!

  • JohnC

    Frankly I am amazed at the number of those who dislike taking insulin by needle and say it’s painful. I am one of those who many years ago, that even thinking about needles, felt weak in the knees and almost sick to my stomach. With the so much better control you get over just taking drugs it was a no brainer decision.

    If you are using the needles today and doing it right nine times out of ten you should feel nothing. With the advise of a Doctor who has Type 1 diabetes I learned some shortcuts to make it all the more convenient as well. If your Doctor won’t show you the right way to inject (painless) on themselves get another doctor.

    As for “serap’s” daughter, you need to get help. This type of distress doesn’t need to happen. Insulin will help her live a much healthier life.
    Maybe Mom should learn to inject painlessly (no insulin of course) and show her daughter — that approach works wonders.

  • Kathy smith

    I would love to try it. Has to b an improvement over needles



  • Larry Tucker

    Yes, I would be interested I now take insulin by injection.

  • m jones

    If it proves to be safe, then absolutely. In fact I will speak with my md about it.

  • Ann R Clark

    I have been diabetic (Type 1) for over 50 years. I am now on an insulin pump. I can’t stand it. Injections (4-6 per day) left less black & blue marks. I do not have enough places to inject my pump and sensor. A nasal spray would be wonderful.

  • Dan

    I have had type 1 diabetes since I was 10 years old. I take lantus 1x/day and novolog 3x/day and as needed.
    I would be interested in learning about the inhalable insulin and using for trial study if available.
    Please let me know. Am tired of the needles. Would be nice to have an alternative

  • Becky

    I would want to see research on the impact it has on the respiratory system. Also, I would need to see the dosing requirements. I am very sensitive to insulin and take small amounts before each meal, sometimes in half unit increments, such 2 1/2 units per meal. Could a powder be measured out like that?