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Xolair

The Xolair injury attorneys at the Drug Law Center are now accepting anti-inflammatory medication injury cases involving patients who have suffered serious harm.

Introduction

Xolair Drug RecallXolair (omalizumab) is a popular injectable anti-inflammatory drug used to treat asthma. The medication is effective because it decreases allergic responses. To date, remains the only drug that was specifically designed to treat pediatric patients 6 years and older who are suffering from moderate to severe persistent allergic asthma. Usually, the doctor prescribes pediatric patient Xolair because of the unsuccessful results with inhaled corticosteroids at reducing asthmatic symptoms.

The History of Xolair

The Houston, Texas-based pharmaceutical company Tanox created the antibiotic medication in 1987 that would lead to the further development of Xolair, which is now manufactured, marketed and sold by Novartis. While the medicine was first designed to reduce sensitivity levels to allergens, many doctors prescribe the medication as an effective solution for controlling severe allergic asthma that will not respond to corticosteroids, even at high doses. Today, the drug is approved for treating individuals 12 years and older who suffer moderate to severe allergic asthma.

The generic version of Xolair, omalizumab, received its first approval in Australia in 2002. That was followed by approval in the United States in 2003, and the European Union 12 years later in March 2014. Other countries have used the medication to treat chronic idiopathic urticaria (chronic spontaneous urticaria – or CIU) when H1-antihistamines are ineffective.

Who Should Avoid Taking Xolair?

Like all OTC (over-the-counter) medications and prescription drugs, Xolair and its generic form omalizumab have contraindications, or some patients might experience harsh adverse reactions and life-threatening effects. The FDA, doctors, the medical community, and the pharmaceutical company that manufactures and sells Xolair know that some patients can have a severe hypersensitivity reaction to Xolair and its active ingredients. Before taking Xolair, it is important to check with the prescribing physician especially if the patient is suffering from one or more of the following conditions that include:

  • Malignant cancer or malignant tumor
  • Vasculitis
  • Blood vessel disease
  • Heart disease
  • Increased cardiovascular events
  • Nerve disease
  • An infection that was caused by more than one form of worm

The FDA has also issued precautions to consumers considering taking Xolair or the generic version omalizumab. These include:

  • “Anaphylaxis: Administer only and healthcare setting prepared to manage anaphylaxis that can be life-threatening and observe patients for an appropriate period of time after administration.
  • Malignancy: Malignancies have been observed in clinical studies.
  • Acute Asthma Symptoms: Do not use for the treatment of acute bronchial spasm or status asthmaticus.
  • Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of Xolair therapy.
  • Fever, Arthralgia, and Rash: Stop Xolair if patient develops signs and symptoms similar to serum sickness.
  • Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids.”

The Black Box Warning on the Xolair drug label involves anaphylactic shock. In part, the Food and Drug Administration has claimed that “anaphylaxis has occurred after the first dose of Xolair but also has occurred beyond one year after beginning treatment. Closely observe patients for an appropriate period of time after Xolair administration and be prepared to manage anaphylaxis that can be life-threatening.”

Xolair Side Effects

Every prescription medication has some form of severe to mild side effects that could place the health and well-being of the patient in immediate jeopardy. Common minor Xolair side effects include:

  • Ear pain
  • Tired feeling
  • Dizziness
  • Leg or arm pain
  • Joint pain
  • Mild rash
  • Itching
  • Cold symptoms including a sore throat, coughing, sinus pain, sneezing and stuffy nose.

More severe Xolair side effects include:

  • Swelling
  • Itching
  • Congestion
  • Changes in voice
  • Hoarseness
  • Muscle pain
  • Lumps
  • Swelling, tender glands
  • Redness
  • Numbness
  • Blistering
  • Bleeding
  • Soreness or dryness of the throat
  • Skin discoloration

The medical community recommends before taking Xolair, it is important to discuss you medical history with the doctor to see if there are any:

  • Indicators of an infection including swollen glands or fever
  • Known allergic reactions to pollen, food, etc.
  • Present or past incidents of cancer
  • Parasite infections including malaria, hookworm, pinworm, and others
  • A history of stroke or heart attacks
  • A history of anaphylaxis (severe allergic reaction)
  • Patients receiving allergy shots

Any individual taking Xolair or the generic version omalizumab has the potential increase of developing prostate, skin, or salivary gland cancer. In addition, Xolair users have an increased potential of becoming infected with worms (parasites) when traveling or living in areas that are common to parasite infections. Studies have not been conducted yet to determine if the active ingredient in Xolair, omalizumab, can pass into the breast milk and breastfeeding mothers. If so, has the potential of causing significant harm to the nursing newborn.

Some doctors perform frequent medical tests on patients taking Xolair to provide reports on lung functioning and allergies. Some test may include a check for parasites, especially if the patient has recently traveled. To minimize the potential of serious side effects, it is essential to take the medication as directed by the drug manufacturer and the doctor’s instructions.

Xolair and the FDA

  • FDA Issues a Safety Alert concerning Allergic Reactions Caused by Asthma Medication XolairFebruary 2007 – The Food and Drug Administration issued a Safety Alert that it was strengthening warnings for the popular asthma treatment medication Xolair administered by injections. The FDA was notifying the medical community and consumers of the product that taking the medication has the potential of causing a potentially fatal anaphylaxis reaction.

    The FDA warned consumers that the brand-name Xolair, and its generic form omalizumab has the potential of causing an allergic reaction at any dose and can last up to one day or longer following the injection. The time patients are experiencing the allergic reactions are significantly longer than first thought when the federal agency in the medical community believed would occur within the first 2 hours. Additionally, allergic reactions were happening to patients who showed no allergic reaction when receiving their initial doses.

    The alert by the Food and Drug Administration was concerning, because many patients were suffering life-threatening systems including chest tightening, swelling of the throat or mouth, difficulty in breathing, height, itching and fainting

 

  • FDA Announces Potential Link Found between Cerebrovascular/Cardiovascular Events and Taking XolairJuly 2009 – The Food and Drug Administration started an investigation involving the potential link of taking Xolair and its generic form omalizumab and the increasing number of cerebrovascular and cardiovascular adverse events.
  • FDA Mandates Update Black Box Warnings for Asthma Drug XolairNovember 2014 – The U.S. Food and Drug Administration (FDA) reviewed findings of an extensive five-year study to determine additional warnings where required on the Xolair Black box warning label to inform consumers of the potential risk of developing serious side effects. These included health problems, brain issues, and potential risk of developing cancer when taking the asthma drug.

    The injectable medication is administered by a physician at intervals of 2 to 4 weeks. All patients must be 12 years and older who experience asthma symptoms that cannot be controlled using traditional inhaled corticosteroids.

    The Safety Alert issued by the FDA indicated that Xolair (omalizumab) has the potential of increasing the risk of life-threatening blood vessel issues in the brain and heart. Because of that, a determination was made that the existing Xolair Black Box Warnings were ineffective and incomplete. The FDA recommended that the drug manufacturer includes a variety of other known problems involving deadly side effects created by Xolair that include:

    • Heart attacks
    • Mini-strokes
    • Unexpected, sudden onset chest pain
    • Transit ischemic attacks (TIA)
    • Venous thrombosis (vein-originating blood clots)
    • Pulmonary embolism (lung-originating blood clots)
    • Pulmonary hypertension (lung artery-related high blood pressure)

    The reason for the safety alert issued by the FDA came after the federal agency concluded that the asthmatic treatment medication was linked to the increased potential risk of severe cerebrovascular and cardiovascular adverse events. However, the drug is also known to cause unstable angina and myocardial infarction (heart muscle death).

  • FDA Approved Xolair for Pediatric Allergic AsthmaJuly 2016 – By the end of the summer in 2016, Xolair can be prescribed by doctors to treat younger pediatric patients 6 years or older who are suffering from an uncontrolled persistent allergic asthma at the moderate to severe level. This FDA approval change could potentially affect more than 6 million younger patients in the United States. The asthma treatment medication has already been very popular since it was approved for pediatric patients 12 years and older in 2003 whose condition cannot be controlled using traditional inhaled corticosteroids medications.

    The FDA went ahead with the approval because clinical trials support including placebo control, double-blind, randomized, multi-Center face three studies said that Xolair was safe and effective for children between the ages of 6 years and 11 years suffering persistent uncontrolled allergic asthma. The initial clinical trials lasted 52 weeks. However, the data used to approve the use and children 6 years to 11 years old was derived from a 28-week study

Filing a Xolair Lawsuit

Time is of the essence for filing a case. This is because every state has enacted laws that limit the amount of time any injured victim can file a claim or lawsuit against parties that caused them harm, damage, or injury. This includes family members who lost a loved one through a wrongful death caused by someone else’s negligence, recklessness, or carelessness.

Once a statute of limitation expires, the injured party is barred from filing any action against any party related to their case. Because of that, victims will often hire personal injury attorneys who specialize in wrongful death cases, product liability lawsuits, medical malpractice compensation claims to ensure they receive adequate compensation for their injuries.

We Are Now Currently Accepting Xolair Cases

The Xolair injury case attorneys at the Drug Law Center are now ready to assist patients who have suffered serious harm by the asthma medication. If you have been injured or lost a loved one due to a life-threatening allergic reaction or serious side effect caused by taking Xolair or its generic form omalizumab, you may be entitled to recover financial compensation for your damages. Our law firm has successfully resolved asthma injury lawsuits, wrongful death cases, and product liability compensation claims.

To minimize the financial burden on our clients, we accept product liability and drug injury cases through contingency fee agreements. This means we provide immediate legal services and handle every aspect of the case and do not accept payment for our legal services until we successfully resolve the lawsuit through a jury award at trial or negotiated an acceptable monetary settlement on your behalf.

We offer a free, no-obligation case consultation to discuss the merits of your claim. Contact us now to speak with one of our attorneys to discuss your legal options on how to pursue your compensation case.

 

Sources:

http://www.mayoclinic.org/drugs-supplements/omalizumab-subcutaneous-route/description/drg-20065207

http://www.clevelandclinicmeded.com/medicalpubs/pharmacy/janfeb2004/omalizumab.htm

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf

https://www.fda.gov/Drugs/DrugSafety/ucm414911.htm

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