The U.S. Food and Drug Administration (FDA) forced additional safety information to be added to the warning labels of the common asthma drug Xolair, concerning potentially dangerous Xolair side effects.

The possible Xolair side effects include heart attacks, strokes, blood clots, and cancer risks. Xolair manufacturer Genetech is being faced with Xolair lawsuits and Xolair class action lawsuits, claiming that the warning labels did not include adequate warnings over the serious potential Xolair side effects.

The FDA warning came out in September and followed a five-year study on Xolair conducted by Genetech. The FDA reviewed the findings from the Xolair study upon completion. Concerns about Xolair side effects, such as an increase risk of heart attack or mini stroke, became more public with the FDA’s findings.

The FDA found that there was reason to believe that patients taking Xolair might have an increased chance of heart and brain problems. Their concern was about the blood vessels that went to the heart and brain.

While the evidence was suggestive of Xolair side effect problems, the FDA claimed the study was not conducted in a way that allowed the FDA to make a definite claim or find the exact risk levels associated with Xolair.

Xolair Warning Labels 

The Xolair side effect findings were, however, enough for the FDA to change the warning labels on Xolair. The warning labels now include the risks of heart attack, mini-stroke, and even cancer.

Additionally, in 2007, the warning labels were changed to include the risk of anaphylaxis or a potentially dangerous, severe allergic reaction. 

Xolair was introduced into the medical market in 2003 as an alternative to inhaled steroids for severe asthma patients (in both adults and children over the age of 12). Xolair can also be used to treat chronic hives (chronic idiopathic urticaria). The drug is given to patients as an injection every two to four weeks.

Xolair lawsuits are being filed and a Xolair side effect class action lawsuit investigation is underway. Xolair lawsuits are claiming that Genetech was previously aware of the dangers included in the FDA warning but failed to adequately inform doctors and patients of Xolair side effects.

The FDA Xolair warning now includes the risk of severe heart, brain, and blood vessel problems, also including the possibility of cancer. The exact risk of these Xolair side effects is currently unknown due to the Genetech study design.