Xolair, also known generically as omalizumab, is a medication used to treat allergic asthma and a condition called chronic idiopathic urticaria. It is made by Genentech, and was first approved by the U.S. Food and Drug Administration (FDA) in 2003 to treat asthma and not until 2014 to treat chronic idiopathic urticaria. Xolair is only for adults and children over the age of 12 and is reserved for treatment of conditions that are severe or that don’t respond to other medications.

This injectable asthma medication is a popular choice and is tolerated well by many patients, but there are also some serious possible side effects. Severe allergic reactions, which can be life threatening, and heart and brain problems are possible for people taking Xolair. Some people have accused Genentech of unethical practices in marketing Xolair, and with lawsuits pending the company may end up paying out fines and settlement compensation.

What is Xolair?

Xolair is a medication called omalizumab and it was first created and tested by Genentech in the late 1990s with approval from the FDA coming in 2003. The main and original use for Xolair, which is given as an injection, is to treat severe allergic asthma. Not all asthma is triggered by allergies, and not all allergic reactions trigger asthma, but when an inhaled allergen does cause the breathing problem, standard treatments don’t always work. Xolair is typically prescribed when corticosteroid treatment is not effective.

In 2014 the FDA approved Xolair for the treatment of another type of allergic condition called chronic idiopathic urticaria, or chronic hives. Usually hives, which is a type of skin reaction, is treated with an antihistamine like Benadryl, Zyrtec, or Claritin. When these don’t work, a doctor may prescribe Xolair. It is not used to treat other types of allergies or conditions and it is not used to treat a sudden asthma attack.

Xolair is administered as an injection, every two to four weeks for allergic asthma, and every four weeks for chronic hives. The positive benefits of the injection may not be seen right away. For this reason, doctors will tell their patients not to stop using other allergy medications until instructed to do so.

How it Works

Omalizumab is a monoclonal antibody, a type of protein made by immune system cells that binds to a specific substance. Antibodies bind to pathogens to help the immune system fight infections. In people with allergies, they attack what should be harmless substances, allergens like peanut protein or pollen.

One antibody implicated in most allergies is called immunoglobulin E, or IgE. Omalizumab binds to IgE, and the effect is that it prevents or stops the allergic reaction. For someone with allergic asthma, getting an injection of Xolair prevents allergens from triggering an asthma attack.

Side Effects

In patients using Xolair to treat allergic asthma, the most common side effects are joint pain, leg or arm pain, generalized pain, dizziness, fatigue, bone fractures, earaches, dermatitis, or inflamed skin, and itchy skin. For those being treated for chronic hives, the most common side effects of Xolair are the common cold, sinus infections, nausea, joint pain, headaches, upper respiratory infections, and a cough.

Anaphylaxis

The most severe type of allergic reaction is called anaphylaxis. Some allergy sufferers only experience mild reactions, but some may experience anaphylaxis when exposed to an allergen. It is life-threatening and must be treated as a medical emergency. Signs of anaphylaxis include shortness of breath, difficulty breathing, a rash or itchy skin, and swelling in the face, mouth, and throat.

One to two out of every thousand patients using Xolair will have this extreme reaction to it. Anaphylaxis may occur any time within 24 hours of receiving an injection, so it is very important to watch for the signs during that time and to seek emergency treatment if necessary. Because of this possible risk and the serious nature of the consequences, the FDA requires that Xolair labels and prescribing information include a black box warning about anaphylaxis, the warning reserved for the most serious side effects of a drug. The FDA added this warning requirement in 2007, four years after the drug was on the market.

Heart Attack and Stroke

Another serious possible consequence of using Xolair was first announced by the FDA in 2009. The organization sent out a communication that there was a possibility of an increased risk of adverse cardiovascular and cerebrovascular events in patients taking Xolair. This early communication warned that an ongoing study suggested the risk was there, but that further study was needed.

The study that found these results was conducted by Genentech and involved about 5,000 patients being treated with Xolair. The results showed that there was an increased incidence among these patients of blood clots, pulmonary hypertension, heart attack, arrhythmias, ischemic heart disease, cardiomyopathy, and strokes.

In 2014 the FDA followed up with approval for labeling changes to Xolair to inform patients of the slightly increased risk of the heart problems and stroke. The risk is not high enough for the FDA to have included it as a black box warning, as concluded after reviewing the completed five-year study and other clinical trials.

Other Serious Potential Side Effects

In addition to the possibility of heart attack, stroke, and anaphylaxis, the label for Xolair contains other troubling warnings. These include the fact that in clinical trials, a slightly increased risk for cancer seemed to have emerged. The label also warns that fever, a rash, and pain are possible and that stopping treatment with corticosteroids too soon could worsen allergic conditions.

Lawsuits

Xolair has been a big seller for Genentech, which has been marketed by Novartis Pharmaceuticals. With the serious possible complications, though, not all of which were included in warnings when the drug came out, lawsuits may nag these companies for years to come. Litigation has been started, with the first cases beginning when the risk of anaphylaxis first came to light in 2009, and again in 2014 with the knowledge that Xolair could cause heart problems.

One lawsuit, unfortunately, has already been dropped. It began when a whistleblower claimed that Novartis and Genentech had marketed Xolair as safe when they knew it was not always safe, that they provided kickbacks for selling the drug, and that they committed fraud. A judge decided that fraud probably occurred, but that there was not enough evidence to be sure.