At the end of September, the U.S. Food and Drug Administration (FDA) published a drug safety communication to the American medical community and drug consumers about possible severe side effects associated with the popular Asthma medication Xolair.

Xolair (also known as omalizumab) is an asthma injection designed and manufactured by biotechnology company Genentech Inc. In 2003, Xolair was approved as a safe and effective treatment to manage asthma symptoms for patients 12 years of age and older diagnosed with moderate to severe and chronic asthma.

According to Xolair drug use information, Xolair injections are generally administered to a patient every two to four weeks by a health care professional. The omalizumab injection can help reduce the number of asthma attacks overall a patient with allergic asthma experiences, and is especially meant to aid patients who still suffer from symptoms after taking inhaled steroids.

However, while Xolair offers great benefit to chronic asthma sufferers, recent medical studies and consumer reports suggest that Xolair side effects allegedly cause Xolair users to experience serious heart, brain, and blood vessel complications. In 2009, in light of these side effects and complications, Genentech was mandated by the FDA to conduct a five-year ongoing safety review of omalizumab.

In September, after reviewing the data of the five-year drug study on the allergic asthma treatment, the FDA concluded that new warnings regarding previously unknown Xolair side effects need to be published in Xolair package inserts and prescription information.

Within the month, the FDA also released the drug and safety communication warning doctors and consumers that Xolair side effects could potentially cause individuals to experience mini-strokes, heart attacks, chest pain, high blood pressure, blood clots, and other severe complications. The FDA drug communication also indicated that this study and other Xolair clinical studies suggested patients using Xolair may be at a higher risk of developing cancer.

Some reported Xolair side effects include:

• Heart attack
• Mini-strokes
• Transient ischemic attacks (TIAs)
• Sudden chest pain
• Pulmonary hypertension (high blood pressure in the arteries of the lungs)
• Pulmonary embolism (blood clots in the lung)
• Venous thrombosis (blood clots in veins)
• Cancer

Overall, Xolair allegedly increases an individual’s risk of experiencing severe heart issues, cerebrovascular problems, and may even possibly lead to the development of cancer.

Patients and families of patients who have allegedly experienced any of the above named Xolair complications should consider filing a Xolair lawsuit or joining a Xolair class action lawsuit.