The FDA has been scrutinizing the safety of a relatively new asthma medicine called Xolair (omalizumab). We would not normally issue a People’s Pharmacy Alert at this early stage of the investigation, but a recent guest on The People’s Pharmacy radio show was so enthusiastic about Xolair that we feel it necessary to temper her enthusiasm with some words of caution.

Xolair is a high-tech treatment that involves a shot every two to four weeks. It targets an antibody called IgE and according to our guest, really helps control moderate to severe asthma.

The trouble with some of these biotechnology treatments, though, is that you are meddling with Mother Nature. The new FDA “Communication on Safety of Xolair” warns about “adverse events involving the blood vessels of the heart or brain (cardiovascular or cerebrovascular events).” That sounds suspiciously like heart attacks and strokes.

Several weeks prior to this new communication the FDA warned about an increased risk of irregular heart rhythms, heart failure, blood clots and pulmonary hypertension in patients taking Xolair. These are all very serious, if not life-threatening, adverse reactions.

Other serious side effects associated with Xolair include upper respiratory tract infections (20%), sinusitis (16%), sore throat (11%) and headache (15%). There has also been a concern raised about a risk of cancer (breast, prostate and skin). Messing with Mother Nature sometimes has unexpected consequences. The powerful biotech TNF blocker arthritis drugs (Cimzia, Enbrel, Humira, Remicade and Simponi) now come with cancer warnings (lymphomas) in children and adolescents:  

The FDA is careful to recommend that patients “not stop taking Xolair without the advice of your health care professional.” The People’s Pharmacy would strongly suggest that anyone receiving Xolair injections have a heart-to-heart talk with the prescribing physician and make sure he or she has carefully considered the new FDA safety review about Xolair!

To see the FDA’s latest MedWatch Safety Alerts for August, 2009 including “Male-Enhancement Products Marketed as Dietary Supplements, Stealth Chocolate Powdered Dietary Supplement and Early Communication on Safety of Xolair” go to:

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  1. p

    I have been on Xolair for just over a year. (Three shots twice a month.) I am athletic: I race bicycles and do hard workouts three or four times a week. I also have asthma and COPD. In my life I try to rise above these illnesses.

    I began to get seriously ill four years ago with a slow descent into what was finally diagnosed as aspergillosis. (Living in a very damp house, in a very damp country). Sporanox was used to treat this but during the treatment I experienced a total asthmatic collapse and ended up in hospital. I was stabilized and sent home. Things didn’t improve much until I was put on Xolair. I also moved to another house. Here I am over a year later, and I’m now stopping Xolair. My life has improved one thousand fold. I am feeling fitter and stronger than I ever have. (I’m 47) I don’t know whether the Xolair or the new house brought me to better health but I’m looking forward to a bright future with one less drug in my system.

    When I started Xolair I immediately had headaches, nausea and vertigo. After a couple of months these subsided but were replaced with extreme joint stiffness. Some old mountain biking shoulder injury pain also resurfaced. A link with the treatment was denied by my doctor but after a couple of months of me reminding him, he finally told me that there is a link. (My doctor and respiratory specialist are brilliant by the way).

    Right now I’m being weaned off from three shots twice monthly to once monthly for four months. I’m super vigilant about with peak flows and very aware of how I feel day to day so I’m reporting back regularly. All is going well. I’ll be Xolair free before next spring, and the new race season!

    I hope this helps someone else. I struggled to find relevant information, and there are very few people in Ireland getting this drug. One thing I know is that we are all different.

  2. Lori

    I’ve been on Xolair since 2008. It was a miracle drug up until the last few years. Really, the symptoms started before that, but weren’t too bothersome. The fatigue, joint pain, swollen lymph nodes. My doctors couldn’t find anything wrong. Lab work always came back normal. The past 2 years have been hell; I’ve been on predisone and antibiotics every couple of months. The day of my last injections, I started feeling unbearably fatigued and went to bed early. Woke up the next day feeling like I’d had a heart attack. My heart was racing, extreme muscle fatigue, chest/lung pains, cough, and shortness of breath. It took nearly two weeks to feel somewhat back to an acceptable normal. I would rather deal with asthma than the side effects, especially if I am going to have to take prednisone anyway. I’m currently at 5 weeks past my last injections, and *knock on wood* feeling not bad considering the pollen levels. Actually using my rescue inhaler a lot less.

  3. Carmine fico

    I’ve been taking it for 3 years my knees ankles and feet are killing me

  4. Doris

    I take 3 shots every 2 weeks. Got my second shots 2 days ago. 3 days after first shots I got plantat fasciitis, did not think it had anything to do with the shots even though I knew about possible side effects. It disappeared and after the second shots, same thing happened and after a shopping spree ( in sandals), the fasciitis reapeared along with achille’s tendon pain. Now I wonder if it is a side effect, and if it means I will have to stop xolair. I hope not.
    I will call my allergy specialiston Monday and hope he will not tell me I have to stop.

    • Jane

      I don’t think the plantar fasciitis is caused by the Xolair. I too have plantar fasciitis and find that in the summer months when I tend to wear sandals and/or go barefooted, the pain and soreness from Plantar fasciitis flares up. If I do the recommended stretches before getting out of bed and also pay attention to the shoes I wear and not going barefooted, I am not bothered. I’ve noticed this in the cooler fall and winter months when I wear closed toed shoes. I’ve been taking 2 shots of Xolair twice a month for around three years now.

      • Michele

        I developed plantar fasciitis after two months of shots and it went away after I stopped taking the shot.

        • jason

          how soon after your first two shots did the foot and toe pain go away?

  5. Denise R
    Oak Lawn, IL

    How does anyone afford staying on this drug. Any suggestions on how I can pay for this medicine and soon I will be on Medicare.

    • Jane

      There is patient assistance through The Macaluso Group. Your doctor’s office should have information about how to apply for patient assistance. Even if you are not on Medicare, you can qualify for this assistance. If I didn’t get this assistance, I wouldn’t be able to afford the medication.

  6. Ivania

    I started Xolair for a year and after having good results I decided to stop as I felt really good. I have now restarted the dose biweekly but this time I have been experiencing some crazy side effects. For the past two months I have been noticing that the pain on my feet and ankles is getting worst. Specially when I wake up in the morning and have to go down the stairs. In addition my sinuses are completely shut so I am now using sinus medication. Although my asthma is under control and I seldom use my inhalers, I am worried about the pain on my feet that is making it unbearable to walk at times. I did consult my doctor of this and I was told that Xolair does give joint pain in some patients.

  7. Andrea

    I have been on Xolair once monthly for 4 years. I had chronic urticaria and that disappeared after the 3rd injection. But it has come at a cost. Every time I get a shot, I am “wiped out” with fatigue and dizziness for days. I have sore underarms for a week or so (maybe lymph nodes??), and lately, the muscle and joint pain is unbearable.
    I don’t have constant hives, but my hands and feet keep swelling and going numb. I think I’m still reacting, but instead of coming out in hives, it’s expressing itself in other ways. I have a general feeling of unwellness that never goes away.
    I want to quit getting the injections, but my Dr is very against that decision.
    We’re actually wondering if I’m having a “serum-sickness like” reaction to the Xolair. I had similar reactions to a few medications previously (Singulair was one of them!).

  8. LJ in South Florida

    I have been getting 2 Xolair shots every other week for about a year now in conjunction with allergy shots – before Xolair, I suffered from severe allergies to the point that my ear canals swelled up & I had trouble hearing (I thought I was going deaf) – my severe sinusitis has been a thing of the past (knock on wood!) and my asthma problems have all but disappeared.
    When the weather acts up, as it usually does down in South Florida, I get minor symptoms of plugged up ears, a sore throat from post nasal drip and a sinus headache – but once the weather clears up, I feel much better – my life has changed so much since I started a regular regimen of Xolair injections – I’m sure all medications have side effects – it just depends on whether you & your doctor believe the benefits outweigh the side effects – communication with your doctor is CRUCIAL in any decision regarding medication. I hope my experience is helpful to someone out there!

  9. Carol G.

    I have been taking Xolair shots now for over a year, (2 shots once monthly), and I have not had the serious asthma attacks that I had before. I am still taking the usual asthma / allergy meds as well. I have not noticed any severe side effects, but was wondering about my cholesterol? My cholesterol has been high ever since beginning Xolair!

  10. Elaine C.

    I have been receiving the Xolair shot twice a month for the past 6 months. I am currently off “all my asthma drugs”!! That is how well the product works… but… I have had weird happenings to my body sense I started the shots. Two weeks after my first shot I woke with all my joints hurting. Pain was everywhere. I talked to my Asthma doctor and he said that the Xolair had nothing to do with this new problem. I say why not. It was right after my shot and began right away. It has eased up somewhat due to my pain meds.
    Another problem I have had twice in the past was that after a shot that same night I got small bright red dots all over my mid-section. By morning these dots were covered with red splotches and then turned to welts. It took 4 weeks for everything to go away. Again I talked to my Asthma doctor and he said that the Xolair had nothing to do with this new problem. I wonder why he is so positive that the Xolair had nothing to do with my new problems? This drug is very new and it is just kind of weird that I have these two new health problems sense taking the Xolair shots. Is Xolair a TNF blocker?
    I wonder if anyone else has experienced these problems and I would like to find a blogging address where I can read other peoples feedback, the real feedback if you know what I mean. Thank you. Wondering

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