Xolair (omalizumab) is an injectable medication used to treat allergic asthma in patients whose asthma has not responded to more traditional medications such as inhaled corticosteroids. The original approval of the medication was in 2003. It was also approved in 2014 to be used as a treatment for chronic idiopathic urticarial or chronic hives in patients who have not responded to traditional antihistamines.
It is not approved for other allergic conditions or other types of asthma and has only been tested and approved for adults and children over 12 years of age.
Xolair is manufactured by Genentech, a U.S. subsidiary of the Swiss-based pharmaceutical giant, Hoffman-LaRoche and is produced in cooperation with Novartis International AG, another pharmaceutical giant. Genentech has yearly estimated revenue of $13 billion and is the largest “biotech” company operating in the U.S. with a concentration on high-tech “biological drugs”, a newer type of medication.
Novartis, the third largest pharmaceutical company in the world, has estimated annual revenue of $58 billion and is also based in Switzerland but has a focus in several therapeutic areas including auto-immune disease and vaccines, along with others.
Xolair is currently protected by a patent in the U.S. and there are no generic alternatives available, with annual U.S. sales of the medication exceeding $800 million. As Xolair is a newer drug, with sales that increase yearly, adverse event reports are also increasing in number. Reports of injuries caused by Xolair have sparked FDA interest, prompting further investigation into the safety of the medication.
Xolair Side Effects
Multiple reports have been received by the FDA regarding injuries caused by Xolair including:
- Pulmonary Hypertension
- Heart Attack
- Deep Vein Thrombosis
- Pulmonary Embolism
- Other cardiac conditions such as ischemic heart disease, arrhythmias, cardiac failure and cardiomyopathy
- Cerebrovascular Disorder
- Allergic Reaction
Reports have shown that effects may occur immediately after administration but in other cases, may develop over a period of time, and not be noticeable for a year or more.
Concerns about the safety of Xolair began surfacing in 2009 with an early communication from the FDA following a five year safety study known as EXCELS which compared 5,000 Xolair treated Asthma patients with 2,500 asthma patients who did not receive the medication. The study showed patients who received Xolair injections had a disproportionate occurrence of ischemic heart disease, heart arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, pulmonary embolism, and deep vein thrombosis.
While reports were under consideration, Xolair was approved for the treatment of chronic urticarial in March of 2014. In September of 2014, the FDA determined that prior label warnings were inadequate and issued an announcement requiring added warnings regarding heart complications on labeling of Xolair.
The required warnings will also include an increased risk of related cancers as the FDA could not rule out concerns of cancer risk due to its mechanism of action which blocks Immunoglobulin E, making the body’s identification of cancer cells more difficult. Most commonly Xolair associated cancers include prostate cancer, breast cancer and skin cancer.
New warnings will be included with another “black box” warning, issued in 2007, regarding the potential for anaphylaxis or severe allergic reaction resulting in difficulty breathing and other potentially serious reactions.
A May 2014 report issued by the Institute for Save Medicine Practices also raised questions regarding the appropriateness of use of Xolair which has resulted in some speculation that the medication may be recalled.
Filing a Xolair Lawsuit
As new information continues to emerge regarding the increased dangers of Xolair, patients and physicians may be able to more closely examine possible causes of adverse events and determine a relationship with the medication.
If you or a loved one has experienced adverse events following the use of Xolair, you may be eligible for compensation for medical and other monetary damages. Complications you may have experienced include:
- Heart attack (MI)
- Stroke (CVA), mini-stroke or transient ischemic attacks (TIA)
- Sudden, unexpected chest pain (Angina)
- Pulmonary hypertension (increased blood pressure in leg arteries)
- Pulmonary embolism (PE) or blood clots in the lungs
- Deep Venous Thrombosis (DVT) or blood clots in the leg veins
- Severe Allergic Reactions
If you or a loved one has experienced these or other adverse conditions after using Xolair, a Xolair lawsuit may help you recover damages caused by the medication. Potential damages include financial compensation for medical costs, permanent medical injuries and pain and suffering.
In some cases, awards from lawsuits filed regarding injuries caused by medications can reach into the hundreds of thousands of dollars.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.