On September 16th the F.D.A. released a safety announcement regarding the asthma drug Xolair. Approved by the F.D.A. in 2003, Xoliar is prescribed to asthma sufferers whose condition is not adequately controlled with traditional inhaled corticosteroids. The medication is administered every 2-4 weeks by a physician as an injection. The F.D.A. safety announcement highlights concerns about whether the drug may be causing problems including heart attacks and cancer.
F.D.A. Warns of Potential Heart and Brain Related Problems
According to the F.D.A. their 5-year safety review “found a slightly higher rate of heart and brain blood vessel problems” for those in the study who took Xolair compared to those who did not. The safety announcement says “The heart and brain blood vessel problems included 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.” It is important to note however, that the F.D.A. said that while the data seemed to suggest a concern there were weaknesses in the study which left the F.D.A. unable to “definitively confirm or determine the exact increased level of these risks with Xolair.” The F.D.A. however, did find the risk great enough to warrant “added information about the potential risks of heart- and brain- related problems to the Adverse Reactions section of the drug label.
The safety announcement also highlighted studies which have shown higher rates of cancer for Xolair patients. The F.D.A. did stress that their analysis did not show higher rates of cancer for Xolair patients, but again they did find the evidence compelling enough to add information about the risk of cancer to the Warning and Precautions sections of the drug label.
In summary the F.D.A. reviewed literature which showed potential risks with Xolair. The F.D.A. found problems and limitations with the studies that found these risks, however they did decide to include information on Xolair’s label to warn people about the cancer risk and the heart and brain blood vessel problems. The F.D.A. advised “Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals.”
Hensley Legal Group Can Help You Today
If you or someone you know have taken Xolair and experienced an injury like the ones listed above please contact an experienced medical malpractice attorney at Hensley Legal Group. Our group of knowledgeable attorneys can help you understand your options, and help you determine what your next step should be. Call our office any time 24/7 at 317-472-3333. Or reach out to us on the web. Fill out the ‘Get Help Now’ form, and someone from our office will reach out to you as soon as possible to discuss your options.