Robert J. Boumis  |  October 16, 2014

Category: Legal News

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xolair side effects lawsuitSince 2009, the U.S. Food and Drug Administration (FDA) has been conducting a study on the safety of an asthma drug called Xolair. More recently the FDA mandated changes to the drug’s labeling to reflect the risk of heart problems, blood problems, cancer, and other serious complications.

The FDA issued an Early Communication in 2009 about research into the safety of the active ingredient in Xolair. The FDA had titled this research study “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma” or the EXCELS project.

In EXCELS, the FDA monitored and followed patients 12 years and older to evaluate the safety of asthma drugs. The FDA study involved more than 5,000 Xolair patients and compared their outcomes to 2,500 controls, or patients who did not take the drug. The study was expected to last five years.

The FDA had enough preliminary data in 2009 that the federal agency deemed it prudent to issue an early statement. While the FDA stressed that patients should not stop taking their drugs, the FDA stated that early interpretations of the data suggested the Xolair could increase the risk of a number of serious side effects. This included a variety of heart and blood-related problems.

In 2012, the FDA announced it had completed the EXCELS project. According to the data from the five-year project, the FDA was able to conclude that Xolair increases a variety of health risks.

Many of these health problems were related to blood and heart disease. This includes pulmonary hypertension (localized high blood pressure in the vessels between the lungs and heart), stroke, chest pain, and other issues.

The FDA’s report also noted that they did not observe an increased risk of cancer in Xolair patients, but several other research studies had. The FDA felt that the though their study suggested these health risks, the link was not strong enough to ban the drug.

Instead, the FDA opted to add warning information to the drug’s packaging so patients and their physicians could evaluate the risks for themselves.

Many of the complications seen in the FDA data are related to errant blood clots. Blood clotting is normally part of the healing process after injuries, and stops a patient from bleeding to death. However, when a blood clot forms inside blood vessels, it can block them, starving tissue of oxygen and nutrients.

Depending on where these blood clots form, they can cause a host of serious problems. In the legs, a clot is called a deep vein thrombosis, or DVT. In the lungs, heart, and brain, they are called pulmonary embolisms (PEs), certain types of heart attack, and strokes respectively. These conditions can be life-threatening.

A Xolair class action lawsuit investigation has been launched to explore the possibility of legal action over the risk of serious Xolair side effects like stroke, heart attacks, and other problems.

Such a Xolair lawsuit could allege that the drug’s manufacturers were aware of the risks of serious Xolair side effects, but sold the medication anyway, endangering the public. Lawsuits like this typically seek to recoup the cost of medical care, final expenses, lost wages, and legal fees.

In general, Xolair lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Xolair class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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Join a Free Xolair Class Action Lawsuit Investigation

If you or a loved one used Xolair (omalizumab) and experienced a heart attack, stroke, pulmonary hypertension, pulmonary embolism, blood clots, cancer or other serious side effect, you may have a legal claim. Submit your information now for a free case evaluation.

A Xolair attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.