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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: http://tinyurl.com/lfhfds
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:
http://tinyurl.com/lyjfqb
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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
PEOPLE'S PHARMACY RESPONSE: XOLAIR CAN CAUSE JOINT PAIN AND IT SOMETIMES CAUSES RASH OR ITCH. BOTH ARE COMMON ENOUGH TO BE LISTED IN THE PRESCRIBING INFORMATION. YOU CAN LOOK IT UP AT DAILYMED.NLM.NIH.GOV/