Xolair: When Risk Outweigh the Benefit

The drug Xolair, which is manufactured and marketed by Genentech and Novartis, has been determined to potentially cause some severe side effects that were never previously disclosed to consumers.

Xolair is an FDA approved treatment of allergic asthma, as well as the treatment for Chronic Idiopathic Urticaria (CIU) that cannot be controlled by H1 antihistamine. However, in September 2014, during the course of an ongoing safety review of the generic equivalent of Xolair called Omalizumab, the FDA found that there were side effects that the manufacturer did not previously warn consumers about. These include the risk that Xolair can cause mini-strokes, heart attacks, sudden chest pain, pulmonary hypertension, blood clots in the lungs and veins, and may increase the risk of developing cancer.

Prior to September 2014, the manufacturers were required to have a “black box” warning that Xolair can cause a potential life-threatening allergic reaction called anaphylaxis. Further in May of this year the Institute for Safe Medication Practices said in a report that of the drugs it was testing for hypersensitivity reactions, Xolair has the highest risk and raised questions about a potential recall of the drug. Now, these additional risks of pulmonary hypertension, blood clots in the lungs and veins, and the potential increase the risk of developing cancer must be disclosed.

Of course, these new disclosure requirements cannot help all the people who sustained injuries as a result of Xolair – but were never warned about the side effects. In pending lawsuits, there are plaintiffs who are alleging that Genentech and Novartis had actual knowledge about the serious risks that are associated with taking Xolair, but failed to provide adequate warnings to patients receiving treatment.

Currently, patients who believe they were injured from taking Xolair are still filing lawsuits on an individual basis but a class action could be filed if enough people come forward.

If you or someone you love has been impacted by the effects of Xolair (Omalizumab), you should contact an attorney who has experience handling pharmaceutical cases. You should contact Jacoby & Meyers, who will place you in contact with the skilled attorneys who specialize in these kind of cases.

Joseph Coughlin, student intern Jacoby & Meyers, LLC.