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Xolair Side Effects Linked to Heart Attacks, Strokes and Other Problems

Austin Kirk

An ongoing study of the asthma drug Xolair indicates that it could cause a number of heart-related side effects, some of which could be fatal. The FDA issued an early communication indicating that they are reviewing the potential Xolair side effects, but that no conclusions have been reached.

>>FDA EARLY COMMUNICATION: Xolair Heart Side Effect Review

According to the statement issued by the FDA on July 16, 2009, interim data from a study conducted by Genentch, the manufacturer of Xolair (omalizumab), suggests that users of the drug could face an increased risk of heart attacks, strokes and other potentially life-threatening problems. At this time, no conclusions have been reached by the FDA about the causal connection between the study findings and Xolair side effects, but the information was provided to inform the public about an ongoing safety review of the drug.

The study, Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), compared the long-term safety of Xolair over five years use to a control group that was not using the drug. Out of 5,000 asthma suffers 12 years old or older, preliminary data has shown a disproportionate increase in:

  • Ischemic heart disease
  • Arrhythmias
  • Cardiomyopathy and Cardiac Failure
  • Pulmonary hypertension
  • Cerebrovascular disorders
  • Embolic, Thrombotic and Thrombophlebitic Events

Xolair was approved by the FDA in 2003 for treatment of moderate to severe persistent asthma caused by perennial airborne allergens, like pollen, grasses and dust. It is prescribed for those whose asthma cannot be controlled by inhaled corticosteroids.

The FDA is continuing to review the emerging safety issue and indicates that further guidance and recommendations will be provided after additional information is evaluated.

XOLAIR LAWSUITS

The product liability lawyers at Saiontz & Kirk, P.A. are closely following the FDA’s evaluation of the potential Xolair side effects to determine whether users who suffered heart attacks, strokes and other serious injuries may be entitled to compensation through an Xolair lawsuit.

Although legal claims are not actively being pursued at this time, if you, a friend or family member have experienced Xolair problems and wish to have a potential claim evaluated as part of our review, request a free consultation.

5 Comments Add Your Comments

  1. Most Xolair patients have multiple conditions which have prompted them to seek this treatment. It is only prescribed to patient’s with moderate to severe Asthma. Patient’s must also have positive allergy testing to qualify for Xolair. It would be very difficult to determine whether Xolair is the causitive factor for cardiac conditions. Xolair has improved the quality of life for many people.

  2. Does anyone know if the drug, Xolair contributes to: Thrombi loosening by decreased inflammation, or 2) sudden anaphylaxis from Xolair that spreads to vascular system, i.e., smooth muscle in the cardiac vascular system reacts in the same manner as the bronchial smooth muscles, e.g., they constrict.

  3. I have been on Xolair for over three years, and my original Doctor that started this therapy on me died of an aneurism in the office. I transfered to another Doctor that refuses to give the injections in his office, thereby causing his patients to go through the outpatient clinic at the hospital, and sometimes it takes three hours to get the damn Xolair mixed and delivered to the floor from the pharmacy. Working people cannot miss that much work. The medicine has been miraculous and I feel much better, but the delivery system needs to improve. There are a lot of medicines that can caus anaphylaxis, so why can’t we give this injection at home. If I had a reaction, my wife could call 911, and I could inject epinephrine. I have just decided to stop the hassle and let my symptoms come back. Disgusted in Springfield, Mo.

  4. Robert change doctors. My husband gets his shots from his Pulmo doctor. He calls the office and the nurse mixes it by the time he gets there it is ready to give. He is usually home in an hour. You can buy a mixer machine to mix the stuff your self and then go to the doctor’s office and have them give you the injection. We use to do this when we lived in a different state only because the doctor did not want to be bothered. We have a better doc now.

  5. To Robert: Did you try Vitamin D3, 5,000 i.u. softgels , 1 per day?
    In my opinion it is far better than a flu vaccine and significant reductions in Asthma attacks during Winter months. 2 instead of 12 attacks reported in the study. Google asthma japanese study vitamin d to find the articles. “Low Vitamin D levels linked to Asthma” – other study. Vitamin D is very cheap . Get your doctor to check D-levels or take at least 2,000 iu per day. I have taken 5,000 per day for over two years and colds and flus are now history here. “Anaphylaxis” is a very serious condition and because it can be caused by other medications as well does not make it less dangerous.

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