Recent studies show that Xolair (omalizumab) allegedly increases the chances of heart attack, mini-strokes, or other serious complications. The FDA has required Genetech, Xolair’s manufacturer, to adapt the labels to warn future users of Xolair side effects, but former and current users might be qualified for legal claims. A Xolair class action lawsuit investigation is currently underway.

Xolair is an asthma injection administered every 2-4 weeks used primarily to treat severe asthma. Xolair may also be used to treat chronic hives. Xolair injections are specifically meant for people for whom the traditional inhaler is not adequate enough. Xolair was approved in 2003 to treat anyone over the age of 12 and is said to be used by 40,000 patients in the U.S. (in 2007).

Xolair Side Effects Study

The Xolair study by Genetech provided five years worth of information for the FDA to review and evaluate. The study involved 7,500 patients: 5,000 taking Xolair and 2,500 taking the placebo. The study confirmed the increase in possible Xolair side effects such as heart attacks, mini-strokes, etc. However, the Xolair study faced some problems: “Although the data are suggestive of a serious safety signal, due to weaknesses in how the safety study was designed and carried out, we are unable to definitively confirm or determine the exact increased level of these risks with Xolair,” the FDA said.

Xolair complications and side effects may include heart attack, mini-strokes, transient ischemic attacks (stroke-like symptoms without the permanent damage), sudden chest pain, lung and vein blood clots, and pulmonary hypertension (high blood pressure in the arteries of the lungs). Concern about these risks began in 2009 when the FDA examined 5 years of data from Genetech.

The FDA indicated that cancer might also be a possible Xolair side effect as well. The FDA was unable to rule out cancer as a possible risk due to insufficient time or numbers in the clinical trials. Cancer is being added to the warning labels as a potential risk.

In May 2014, the Institute for Safe Medication Practices looked into whether Xolair should even be used at all after examining the number of cases of anaphylaxis (a life threatening allergic reaction) that were reportedly associated with Xolair. In 2007, the FDA required that Xolair add a warning label about anaphylaxis. The FDA even forced Genetech to begin the study in 2009 examining the safety of their asthma treatment. This supports the allegation raised in Xolair lawsuits that Xolair is causing severe, unexpected side effects in its users.

Xolair lawsuits claim that Genetech knew about the serious side effects of Xolair but did not provide adequate warnings. The alleged Xolair side effects are dangerous, and possibly life threatening.

Join a Free Xolair Class Action Lawsuit Investigation

Patients who were injured by Xolair side effects may be entitled to collect compensation for medical expenses related to the treatment of their injury, as well as for damages for pain and suffering.

Only a qualified drug injury attorney can determine if you are eligible to file a Xolair lawsuit. You can see if you qualify by filling out the form on this page for a free case evaluation.