Xolair Lawsuits

Xolair was and is a drug prescribed to patients suffering from asthma. However, the use of this drug has serious side effects including heart and brain related issues that include blood vessel problems. Patients using the drug have also suffered strokes, heart attacks, blood clots, pulmonary hypertension, deep vein thrombosis (DVT), pulmonary embolism and chest pain..

Xolair is the proprietary brand name for the drug known as Omalizumab. The drug is taken by injection. The manufacturer of Xolair is Genentech, Inc., which is the name of the U.S subsidiary of the Swiss company F. Hoffmann-LaRoche AG (LaRoche). The drug is marketed by Genentech in the United States in coordination with another company, Novartis International AG. Together, these companies have the exclusive patent on Xolair and at the present time there is no generic that serves the same intended purpose.

The U.S. Food and Drug Administration (FDA) approved Xolair in 2003 for patients over the age of 12 who have moderate to severe asthma and/or year-round allergies. In 2008 alone the sales of Xolair produced $517 million.

It has been reported in a study titled, Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) that 5,000 Xolair patients and 2,500 non-Xolair patients were observed. In this interim study, it showed a disproportionate increase in a long list of severe heart and brain medical issues evident in patients who were taking Xolair. The study is ongoing and will continue for a full five years when all the data will be complete. Patients and healthcare providers are advised to be aware of the wide range of risks and side effects that could come with the prescribing and using Xolair by asthma patients.

Of particular interest and should be noted well that Novartis, the Swiss multinational pharmaceutical company acknowledged that its staff in Japan was guilty of hiding more than 10,000 safety reports concerning the use of Xolair.

The findings that may be contained in those safety reports would have an effect as to the conclusions made by the adverse events that have been reported.

Some other side effects of patients injecting Xolair include severe skin rashes, sudden drop of blood pressure and limb pain. It also should be considered that some of the side effects arise immediately while other side effects may not be experienced for more than a year after treatment.

There is also a potential risk of cancer that has not been ruled out for patients that have been taken Xolair.

These pharmaceutical companies including Genentech, Novartis and F. Hoffmann-LaRoche have been the subject of “whistleblower” cases. In one such case a group of researches asserted that Genentech executives rushed through a study and ignored scientific and ethical standards on pharmaceuticals that proved to be dangerous to patients. Novartis was founded in 1996 and came out of a merger between a Swiss chemical manufacturer CIBA-GEIGY and pharmaceutical company Sandoz Laboratories, both of which traced their origins back to the mid-18^th and 19^th centuries. In brief, the most serious side effects of Xolair are cardiovascular and cerebral vascular.

The FDA in 2013 issued a drug safety communication that warned of increased risk of brain, heart and other serious side effects from using Xolair. The FDA was quoted as stating: “The heart and brain blood vessel problems including mini-strokes known as transient ischemic attacks or TIAs; heart attacks; sudden unexpected chest pain; high blood pressure in the arteries of the lungs called pulmonary hypertension; and blood clots in the lungs and veins. Although the data are suggestive of a serious safety signal, due to weakness and how the safety and design was carried out, we are unable to definitively observe or determine the increased risks of Xolair.”

At the moment, the FDA has not required a recall of Xolair, but the warning about the risk of these serious side effects is out there.

If you or someone you know has been injured or suffered serious side effects from the use of Xolair, you need to contact the experienced pharmaceutical litigation lawyers at Kreisman Law Offices. As a patient who has experienced these serious side effects, you may be able to file an injury case, wrongful death case against the pharmaceutical companies that have manufactured, designed and produced this prescription drug.

Kreisman Law Offices has been handling pharmaceutical defect cases for more than 40 years.

With our years of experience in trying and settling pharmaceutical defect cases around the country, Kreisman Law Offices provides the best possible services to our clients. Our service is unmatched. Please call us 24 hours a day at 312.346.0045 or toll free 800.583.8002 for a free and immediate consultation, or complete a contact form online.