Asthma Inhalers Foradil, Serevent, Symbicort and Advair Increase Risk of Death: FDA Officials Warn

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Several FDA officials have warned that because side effects of Advair, Serevent, Foradil and Symbicort may increase the risk of death, an FDA advisory panel should recommend that approval to use the drugs for treatment of asthma should be withdrawn or severely limited.

These medications are known as long-acting beta agonists (LABAs), and they are commonly prescribed to help avoid the inflammation of airways in the lungs and prevent asthma attacks. While they have been found to keep airways open, use of the medications could potentially increase the severity of future attacks, especially among children.

A panel of independent advisors to the FDA is scheduled to meet this week to review safety data on the four asthma inhalers.

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In advance of these meetings, two FDA officials have concluded that asthma patients of all ages should no longer use Advair, Symbicort, Serevent or Foradil due to the increased risk of death. A third FDA official has indicated that Advair and Symbicort could still be used by adults, but that none of the inhalers should be used by children 17-years-old or younger.

Asthma is a chronic disease which affects 20 million Americans, including 6.5 million children, causing symptoms like difficulty breathing, spasms and wheezing.

Unlike rescue inhalers, which contain the beta-agonist albuterol and have a limited duration, these long-acting beta agonists are designed to be taken daily to prevent asthma attacks.

Advair, which is the biggest seller out of the four asthma drugs, is manufactured by GlaxoSmithKline PLC and generates sales of nearly $7 billion annually. The inhaler combines a steroid with Serevent, which is also made by Glaxo and contains salmeterol as its active ingredient. Sales of Serevent alone were $538 million last year.

Foradil, which contains formoterol as its active ingredient, is manufactured by Novartis AG and marketed in the U.S. by Schering-Plough Corp. It is used in combination with an inhaled steroid is Symbicort, which was introduced by AstraZeneca last year. In the first 9 months of 2008, Symbicort generated sales of just over $200 million.

The drugs already contain “black box” warnings about an increased risk of hospitalizations and death from asthma attacks while on the drugs, which is the strongest warning that can be placed on a prescription medication.

The FDA advisory panel is scheduled to meet on December 10 and 11 to consider whether additional regulatory actions involving use of these inhaled drugs to treat asthma should be recommended.

Even if approval for treatment of asthma is withdrawn, a recall of Advair, Serevent, Fordail or Symbicort will not occur, as the drugs are also approved for use in treating individuals suffering from chronic obstructive pulmonary disease, who are usually elderly.

Tags: Advair, Asthma, Foradil, Inhaler, Serevent, Symbicort
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58 Comments

  1. Thomas

    I
    am a 47 year old male who has been taking advair 500/50, and proventil for 9 or 10 years. I am now having trouble with my eyes, as my eyelids swell up, and make it hard to see at very long distances. Have any of you out there had this problem? I do know that it causes eye problems, I read that on the Dr’s Instructions. I have copd, with chronic bronchitis. I told my doctor about this, and she wants to test me for infections. I went to an opthamologist, and he said it was some sort of auto immune problem, or infection. When I suggested it to my doctors, they told me it wasn’t consistent with problems from advair. Well, I have been having some problems with my copd recently, so I tried some advair 250/50 after taking steroids top clear up my problems with the swelling and running in my eyes, now I have the problem back, and my damn doctor only wants to give me one inhaler, without the help of a substance like advair, but different ingredients, or company, she still wants me to stay with gsk. Bullcrap on that. Any advice out there on the best attorney I can get to sue these pricks? All of them? Thanks
    Tom

  2. shirley

    i recently was given symbicort.I felt fine for the first few treatments on my machine.Then i was given the inhaler.I felt as if i stuck my finger in a light socket. a shock went through my head.severe dizziness.and i felt light headed.disoriented as well.I could barely drive. I’m throwing all my meds away . I’ll stick to albuteral. The doctore told me to take this stuff twice a day every day.heck no. I’m not killing myself.plus my eyesight has gone bad

  3. sarah beth

    have been on symbicourt for 2 years now. have since developed glaucoma, & have started having problems with my teeth. (dry mouth, 2 extractions & a root canal.) i’m telling my doctor i want off this stuff asap.

  4. Joy-Ann R

    For Asthma sufferers try all of the following;

    Google ‘ Tooth Meridians Natural Dentistry Chart’, and click on lungs.

    It tells you which teeth are related to lungs/respiratory, and so on. If there is bacteria/Cavitation it must be cleaned out. Only a licensed Biological/Holistic Dentist can do this. You may have to travel to this Dentist — mine is a 3-hour drive away, but well worth it. Don’t mention to your mainstream Dentist as they’ll surely discourage you.

    Each tooth is linked/connected to specific body organs.

    A Cavity is in the tooth, but a Cavitation is in the bone surrounding the tooth. They can cause real BIG trouble, including Asthma, even if you have no symptoms. Request a Panoramic or similar X-ray and find out if you have a Cavitation. And if so, get the bacteria in the bone/gums cleaned up. Be aware — some insurances don’t cover for Cavitation — only for Cavities. STOP allowing Mercury to be put in your mouth.

    Eliminate all processed/microwaved foods and dairy, wheat, flour, gluten and peanuts from the diet, as well as ALL sugar, including artificial sugar and alcohol. Use sea salt and limit salt intake.

    Buy a shower-head water filter from Sante for $120, as they custom make the shower water filter for the specific crap that is in your water supply coming into your home (they are in the Southwest U.S.) 800-398-6735 or buy one that removes Chloramine and Chlorine, etc..

    Don’t shower in chlorinated water OR you can just get a whole house Reverse Osmosis water filter from Sante for around $995 … and/or drink only water from the gallon jugs of Distilled water. Tap water is bad in most areas for drinking, cooking and bathing and can trigger Asthma in some people.

    Buy a home Air Purifier that removes viruses, toxins, mold spores, etc.. Honeywell sells a real good one for about $200 (U.S.D) that should last at least 5 years.

    Replace bed pillows every 6 months and keep all bedding real clean – –wash weekly. Do not use bedding that needs to be dry cleaned. Also, run every load of laundry through an additional short cold-water rinse cycle to remove excess soap/detergent residue.

    Finally, STOP stressing and thinking negative thoughts and stay away from toxic people who inspire the anxiety that leads to inflammation.

  5. Victoria

    since using symbicort and advair I develop loss of vision of the right eye and
    also have dry eye and lid.
    been developing a chronic clearing of the throat.

  6. keremit

    i dont like symbricort—–only been using 4 days throat irratation hoersness—dont think its a good med —my doc put me on spriva now thats good also have 6mts supply of foradil—from last appt.—im keeping that also use albuterol —damm im a mess —when they going to grow some lungs in the lab —ha ha —im 71

  7. teresa

    I have been on all kinds of inhalers, they haven’t help.its mess.my teeth up, so I have come off my copy med.

  8. Lisa

    My husband was prescribed symbicort and another prednisone inhaler by the VA. He had very bad asthma and after two months on these meds he died suddenly. Not a good medication for those with asthma.

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