Have you or a loved one experienced health problems involving the heart or the blood vessels supplying the brain that may have been caused by Xolair? In September 2014, the asthma medication’s label was updated to include information about these types of complications, following the completion of a U.S. Food & Drug Administration (FDA) safety review. The nationwide law firm of Bernstein Liebhard LLP is now offering free Xolair lawsuit reviews to patients who suffered any of the following side effects:
- Mini-strokes (also known as transient ischemic attacks or TIAs)
- Heart attacks
- Pulmonary hypertension (high blood pressure in the arteries of the lungs)
- Blood clots in the lungs and veins
Because young people rarely experience these types of health issues, our Firm is especially interested in cases involving younger Xolair users. If you or someone you care about fits this profile, we urge you to contact our office today to arrange for a free, no-obligation review of your claim. A Xolair lawyer can answer any questions you have, and can fully explain how you might be able to obtain compensation for all of your injury-related damages.
New Xolair Label Warnings
Xolair, known generically as omalizumab, is an injectable asthma medication that was approved by the FDA in 2003. It is indicated to treat patients 12 years and older with moderate to severe persistent asthma that is not well-controlled by inhaled corticosteroids. Xolair is also approved to treat chronic idiopathic urticaria, a form of chronic hives, in adults and adolescents. In 2009, the FDA announced that it was reviewing the drug, after interim results from a five-year study suggested that Xolair was associated with an increased number of cardiovascular and cerebrovascular adverse events.
The FDA concluded that review in 2014, and in September issued an alert warning that patients treated with Xolair might be slightly more likely to suffer from heart attacks, mini-strokes, chest pain, pulmonary hypertension and blood clots compared to patients who were not using the medication. In conducting its review, the agency had analyzed one five-year study submitted by the Genentech, the drug’s manufacturer, as well as 25 other clinical trials comparing Xolair to a placebo. The FDA noted that while its findings were indicative of a serious safety signal, it was “unable to definitively confirm or determine the exact increased level of these risks with Xolair.”
As a result of its review, new information regarding the potential for cardiovascular and cerebrovascular problems was added to the “Adverse Reactions” section of the Xolair label. Among other things, the FDA has advised health care providers to periodically reassess the need for continued Xolair therapy based on each individual patient’s disease severity and level of asthma control. Xolair patients have been advised not to decrease their dose or stop taking the drug, unless they have been instructed to do otherwise by their provider.
Contact a Xolair Attorney Today
Individuals who suffered serious cardiovascular and cerebrovascular problems potentially associated with Xolair may be entitled to compensation for any damages incurred as a result of these complications, including:
- Medical bills
- Lost wages
- Permanent disability
- Emotional distress
- Pain and suffering
Our Xolair lawyers are ready now to assist anyone who may have been harmed by this medication. If you would like to explore the possibility of filing a Xolair lawsuit, please fill out our online form, or call (877) 779-1414 today to get in touch with our legal staff.