Xolair and Heart Attacks and Strokes

Does Xolair Cause Heart Attacks and Strokes

Can Xolair increase the risk of heart attacks and strokes?. Retales Botijero/Moment/Getty Images

Does Xolair Cause Heart Attacks and Strokes?

Is it true that Xolair may increase my risk of cerebrovascular events like heart attacks and stroke?

In July 2009, the FDA issued a statement regarding the possibility that Xolair (omalizumab) may result in an increase in various cardiovascular and cerebrovascular side effects, such as heart attacks and strokes. These concerns are based on some early data from the “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS)” trial, which is following 5,000 patients treated with Xolair, along with 2,500 other patients treated with other asthma medicines and not Xolair.

Few specifics about the EXCELS study were released, and the FDA is not making any recommendations that patients stop using Xolair. It is not yet known if there is truly a cause-and-effect relationship between Xolair and heart attacks or strokes. Many people who receive Xolair have severe asthma, and often other serious medical conditions that may predispose them to have heart attacks and strokes. Even though a person was taking Xolair at the time of a heart attack or stroke doesn’t necessarily mean that the Xolair caused the heart attack or stroke. Xolair is an injectable medication used to treat moderate to severe allergic asthma. It can be used in people 12 years and older who still have uncontrolled asthma despite typical asthma medications, such as inhaled steroids. Xolair is a monoclonal anti-IgE antibody, which binds to IgE in the bloodstream, allowing the body to remove them before they can cause allergic reactions.

Xolair currently has a “black box” warning, which a precautionary statement given by the Food and Drug Administration (FDA). This warning has come about as a result of reports of people experiencing anaphylaxis after receiving Xolair. During clinical development, the rate of anaphylaxis was less than 0.1% (1 in 1,000 people receiving Xolair injections).

Since Xolair has been available for prescription use, this rate has risen to 0.2% (2 people per 1,000 Xolair injections). It is not yet known whether the FDA will update the current black box warning to include the risk of heart attacks or strokes.

The final analysis from the EXCELS study is not due until 2012. The FDA states that they will continue to communicate their findings to the public between now and then regarding the safety of Xolair. In the meantime, people using Xolair should discuss any concerns that they have regarding the side effects of Xolair with their physician, and should not stop using Xolair without notifying their physician. Stopping Xolair may also have potential risks, such as worsening of asthma symptoms, which could potentially be very dangerous.

Learn more about Xolair and its potential side effects.


Early Communication About an Ongoing Safety Review of Omalizumab (Marketed as Xolair).July 16, 2009. FDA Website. Accessed July 18, 2009.

DISCLAIMER: The information contained in this site is for educational purposes only, and should not be used as a substitute for personal care by a licensed physician. Please see your physician for diagnosis and treatment of any concerning symptoms or medical condition.

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