In September of 2014, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication about the asthma drug Xolair.

Xolair or omalizumab is an asthma drug designed to help treat and control chronic asthma. It treats chronic asthma differently than steroids, the standard treatment. This makes Xolair ideal for treating chronic asthma patients who either do not respond to steroids, or tolerate them poorly.

Since long-term steroid use can have serious side effects, like psychiatric problems, hormone problems, and suppressing the immune system, alternatives like omalizumab or Xolair are important treatment options. However, the FDA has recently found some risks associated with the drug.

According to the Drug Safety Communication, the FDA had completed a long-term study of the safety of Xolair. The five-year study found an elevated risk of heart, brain, and blood vessel problems.

All of these problems are theoretically related, as errant blood clots can cause a wide variety of problems in the body. When the clotting process is altered, dangerous blood clots can form inside the body. These clots can lodge within blood vessels, blocking the blood supply to important tissues and organs.

For example, if a blood clot lodges in the vessels that feed the brain, it can cause a stroke. In the vessels that feed the heart, it can cause a heart attack. The FDA’s study found that patients taking Xolair had a slightly increased risk of developing this constellation of illnesses.

The FDA supplemented their observational study with data from 25 double-blind clinical trials, to increase the strength of their research study. Unfortunately, many of these trials did not have the same follow-up period seen in the FDA’s observational study.

Since the observational study found that the risk could be more long term, the data from the clinical trials made it difficult to make an accurate assessment of the risk for Xolair.

Based on their research and judgment, the FDA has decided to update the warning information included with Xolair prescriptions to include the possible risk of blood-clot related medical problems like a stroke and heart attack. Clot-related problems will now be listed among the possible Xolair side effects on the asthma drug’s prescribing information.

Curiously, the FDA’s five-year study of Xolair didn’t find an increased risk of cancer. Researchers suspected it would, as some clinical studies had found an increased risk of certain cancers associated with the asthma drug.

A Xolair class action lawsuit investigation has been launched to explore the possibility of legal action over the alleged link between Xolair and clot-related health problems like heart attack and stroke.

Such a Xolair lawsuit could allege that the makers of Xolair were aware, or reasonably should have been aware, of the serious risks allegedly associated with their drugs. Similar lawsuits over other drugs have alleged that not only were drug makers aware of such risks, but that they actively downplayed these risks, marking dangerous drugs aggressively, endangering the public.