The FDA issued a warning on Sept. 26, 2014 concerning Xolair side effects. According to a recent study, Xolair, an asthma injection, can increase the risk of heart attack, mini-strokes, and cerebrovascular events. The warning labels were changed to include the recent findings about Xolair side effects.

FDA Xolair Side Effect Warning

The FDA reviewed a five year safety study and found that Xolair patients had a higher risk of heart and blood vessel problems compared to those who did not take Xolair.

According to the FDA warning, “the data are suggestive of a serious safety signal,” although, “due to weaknesses in how the safety study was designed and carried out, we are unable to definitely confirm or determine the exact increased level of these risks with Xolair.” 

The study found increased rates of mini-strokes, chest pain, high blood pressure in the arteries of the lungs, and blood clots in Xolair users. These Xolair side effects were added to the warning labels.

The FDA also reviewed additional clinical trials which examined patients using Xolair and some using a placebo. The increase of heart and cerebrovascular events was found in these trials, but the structure of the trials prevented the FDA from making definite claims about Xolair side effects.

The risk of Xolair users developing cancer from Xolair was a possibility the FDA could not rule out, the agency said. The FDA found the study to be limited in this area as well. The FDA Xolair warning stated, “our review of the 5-year safety study found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated in Xolair.” It was suggested that the length of the study was insufficient for Xolair cancer information. A warning about Xolair cancer was added to the warning labels just to be safe.

The five-year safety study was completed by Genetech, the manufacturer of Xolair. The FDA required this Xolair side effect study in 2009. Nearly 8,000 individuals participated.

Xolair Safety

These Xolair side effect safety concerns are not the first to arise for the asthma medication. In 2007, a black box warning was added to Xolair labels warning against anaphylaxis, a severe and potentially dangerous allergic reaction. It has been questioned if Xolair is worth the risk of all of these potential adverse side effects.

Xolair was approved in 2003 to treat adults and children over 12 with asthma. It can also be used to treat those who has chronic hives. Xolair is typically used when inhaled corticosteroids (the common inhaler treatment) is ineffective. It is given by a health professional every two to four weeks.

Many individuals have filed Xolair lawsuits that accuse Genetech and Novartis (Xolair’s marketers) of knowing about the alleged side effects but of failing to provide adequate warning.