Xolair: Blood Clots or Brain, Heart, and Lung Problems
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Xolair (omalizumab), which is an injectable drug for certain patients with asthma or chronic hives, has been available in the US since June 2003.
The drug companies responsible for Xolair are Genentech (manufacturer) and Novartis Pharmaceuticals (marketing partner).
In September 2014 the FDA issued an update about its safety review of Xolair and therein pointed out these possible Xolair side effects:
- Heart Attacks
- Pulmonary Hypertension
- Blood Clots
- Pulmonary Embolism (PE)
- Deep Vein Thrombosis (DVT)
- Brain Blood Vessel Problems
In addition, as set forth in a 2012 medical journal article, two University of Florida researchers who analyzed an FDA voluntary adverse drug event reporting database found that there was a strong “safety signal” for Xolair as regards cardiovascular death and stroke events.
Back in July 2009 the FDA issued its “Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)” to inform doctors and patients that the agency had started reviewing interim safety findings from a study of Xolair which suggested that this medication may be associated with increased risks for ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and thromboembolic and thrombophlebitic events.
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FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events
This update is in follow-up to the Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair) issued on July 16, 2009.[9-26-2014]
A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, we have added information about these potential risks to the drug label. Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals….
Recent Side Effects Case Evaluations
Xolair – Pulmonary Embolism (PE) – 60 yr old woman
Xolair – Heart Attack – 40 yr old woman
Xolair – Chronic Pulmonary Embolism – 48 yr old man
Xolair – Brain Blood Vessel Problems – 13 yr old girl
Most Recent Article About This Drug
Xolair Is Associated With Higher Than Expected Reporting Of Arterial Thrombotic Events Such As Strokes And Cardiovascular Deaths
While European Drug Regulators Have Been Concerned About This Aspect Of Xolair Safety, FDA Has No Warning About Arteriothrombotic Risks Of Xolair
SUMMARY: In this post we consider a medical journal article which suggests that Xolair is associated with an increased risk of arterial thrombotic events, predominantly cardiovascular deaths and strokes.
To read more of this article, click below:
According to the authors, their study is the first pharmacovigilance analysis to detect from a spontaneous event reporting database such as the FDA AERS a strong safety signal for Xolair as regards cardiovascular death and stroke events.
Numerous times throughout their article the authors acknowledge the limitations of their research methods and state that epidemiological studies are necessary to further explore the apparent association of Xolair with cardiovascular deaths, strokes, and other arterial thrombotic adverse events.[Read this article in full at original source]
Earlier articles by attorney Tom Lamb on the Side Effects Blog:
- Xolair Asthma Drug Associated With Higher Rate Of Heart Attacks, Pulmonary Hypertension, Blood Clots Causing PEs And/Or DVTs, And Brain Blood Vessel Problems
- Asthma Drug Xolair Is Being Investigated By FDA For Possible Cardiac Problems
- Black-Box Warning About Anaphylaxis Being Put On Asthma Drug Xolair
Free Case Evaluation: Xolair >>
All content by attorney Tom Lamb