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The FDA has ordered the addition of a black box warning to the anti-asthma drug Xolair due to the risk of serious life-threatening Xolair side effects. The most serious side effect of Xolair is anaphylaxis, or severe allergic reaction to the drug.
The FDA warns that Xolair can cause this life-threatening anaphylactic reaction at any dose of the medication and even if a patient previously used the drug with no adverse reaction. There is also the risk of delayed reaction to the drug, occurring two to twenty-four hours following a Xolair dose.
Patients suffering from the Xolair side effect of anaphylaxis often require immediate medical treatment, which frequently requires self-administered to avoid more serious injury. Nearly one in five patients will require hospitalization because of Xolair anaphylaxis. While this serious Xolair side effect is life-threatening, the FDA has not received any reports of fatal Xolair side effects.
If you or a loved one has suffered a serious allergic reaction to Xolair, you may wish to confer with a legal expert who can determine your eligibility for compensation for medical expenses, pain and suffering, and more. Please contact our offices for a confidential free consultation with an experienced Xolair attorney and learn more about your legal rights and options to file a Xolair lawsuit.
What is Xolair?
Xolair (omalizumab) is an expensive injectable prescription drug sold by Genentech, Inc. The FDA approved Xolair in June 2003 for use in patients 12 and older. Xolair is used to treat patients with moderate to severe persistent asthma related to allergies caused by perennial aeroallergens, such as grass, dust, and pollen.
Xolair is also prescribed for off-label treatment of allergic rhinitis. Xolair is a secondary treatment intended for patients in whom corticosteroid treatments have not been successful. Xolair has shown to decrease the frequency of worsening asthmatic episodes.
The risk of Xolair side effect anaphylaxis has been known since before the drug was approved by the FDA. In pre-marketing clinical trials, Xolair was found to cause serious anaphylaxis in one out of every 1,000 patients. Despite this risk, Xolair was allowed on the market with some warnings.
Due to numerous post-marketing reports of Xolair side effect risks, the FDA has ordered that additional warnings be included on Xolair and that Genentech provide a Medication Guide to all patients, warning them of these Xolair risks.
The Xolair Black Box Warning
In February 2007, the FDA ordered the addition of a Xolair black box warning to all product packaging for this asthma treatment. A black box warning is the most serious caution the FDA can order short of pulling a medication off the shelves.
The FDA decided to order this additional Xolair warning because of the nature of the anaphylaxis reports the agency had received since the drug was approved, including the risk of fatal Xolair reactions, the frequency of Xolair side effects, and the risk of a delayed onset of adverse reaction to Xolair.
Xolair Side Effect Risks
Xolair can cause a serious allergic reaction called anaphylaxis. The following are the most common symptoms of anaphylaxis:
- Trouble breathing caused by a narrowing of the airways (bronchospasm)
- Chest tightness
- Swelling of the tongue or throat
- A drop in blood pressure
Between June 2003 and December 2005, the FDA received 48 reports of anaphylaxis caused by Xolair. Of these patients, at least seven required hospitalization because of the severity of their Xolair adverse reaction.
The FDA also reports that Xolair anaphylaxis can occur long after the medication is administered. For example, a person may suffer a serious reaction to Xolair two to 24 hours after receiving the injection.
Additionally, the FDA states that an adverse Xolair reaction can happen after the administration of any dose. Patients who have taken Xolair in the past with no adverse reactions are still at risk for suffering the Xolair side effect anaphylaxis.
Expert Advice about Xolair
The FDA is now advising all doctors who administer Xolair to take the following precautions:
• Observe all patients for at least two hours following the administration of Xolair.
• In this time period, be prepared to manage life-threatening allergic reactions, should they develop.
The FDA also urges patients to be aware of the signs and symptoms of anaphylaxis. Patients should also care and know how to use emergency self-treatment, should this adverse Xolair reaction occur. Patients are advised to carry an epinephrine auto-injection called EpiPen.
Other serious Xolair Side Effects
Research also shows that Xolair may increase the risk of certain cancers, such as breast cancer, prostate cancer, and skin cancer.
What to Do if You Are Harmed by Xolair
If you or a loved one has been harmed by Xolair, you may be able to seek compensation for your losses and suffering. To protect your legal rights, it is important to speak with a qualified Xolair lawyer as soon as possible. Our experienced Xolair attorneys are prepared to evaluate your case and determine the best way to help you and your family seek the compensation to which you are entitled.
Oshman & Mirisola can help you make informed decisions about your legal rights, so please call the Xolair attorneys at Oshman & Mirisola at Toll Free: 1(800)-400-8182 for your free legal consultation.