Xolair may be known to provide relief to patients suffering from asthma, but with the serious heart and brain related side effects that may accompany Xolair, it is not exactly a breath of fresh air.
Because there have been a high number of patients experiencing side effects while taking Xolair, the FDA administered a black box warning to be added to all packages of the drug, as well as additional information added to the Adverse Reactions section of the drug label. The black box warning explains the risk involved when taking Xolair and the seriousness of possible side effects, including heart and brain blood vessel problems such as stroke, heart attacks, and blood clots.
The FDA has approved Xolair for patients over the age of 12 who have moderate to severe asthma and year-round allergies, as well as patients over the age of 12 with chronic hives not controlled by an antihistamine. The drug is the brand name for Omalizumab and is administered by injection.
In an ongoing study titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), 5000 Xolair patients and 2500 non-Xolair patients were observed. The interim data revealed a disproportionate increase in a plethora of severe heart and brain issues in the patients taking Xolair. The study will last five years and until all collected data is complete, patients and healthcare providers are advised to be aware of the risks and side effects that could accompany a prescription of Xolair.
In further review of the FDA study, a combined analysis of 25 randomized clinical trials was reviewed. Because there were so few participants, the analysis did not reveal a significant increase in heart and brain related problems; however, the risk was still deemed either likely or apparent due to the study being so limited because of variables such as the number of participants and their age.
“The severity of the risks regarding serious heart and brain issues for patients of Xolair is appalling,” said Levin Papantonio attorney Wesley Bowden who is investigating Xolair litigation. “The small scale by which the FDA studies were conducted does not lead to the full story being told and the suffering of the patients.”
It should also be noted that earlier this year, Novartis, a Swiss multinational pharmaceutical company, acknowledged that their staff in Japan hid more than 10,000 safety reports concerning Xolair, amongst other drugs. These findings may affect the appropriate conclusions made by the adverse events that have been reported.
Other side effects reported by patients taking Xolair are anaphylaxis, severe skin rashes, sudden drop in blood pressure, and joint and limb pain. While some side effects are experienced immediately after taking the drug, other side effects may not be experienced until up to twelve months after treatment. A potential risk of cancer has not been ruled out for patients taking Xolair.