Recent studies have identified a link between the injectable asthma medication Xolair (omalizumab) and an increased risk for problems involving the heart and blood vessels of the brain. As a result of these problems, the U.S. Food & Drug Administration (FDA) has required Xolair warning labels to be updated with information about this risk.
What is Xolair?
Xolair is an FDA approved prescription medication used to treat moderate to severe allergy-induced asthma in adults and children who are at least 12 years old. The drug is typically prescribed after other asthma medications have been unsuccessful at treating symptoms. Omalizumab, the active ingredient contained in Xolair, is an antibody that decreases allergic responses in the body.
What’s the Problem?
On September 26, 2014, the FDA warned that Xolair had been linked to an increased risk of severe cardiovascular and cerebrovascular adverse events. According to the warning:
“An 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.”
The agency’s review found no difference in cancer rates between Xolair users and the general population. However, due to limitations in the 5-year study, an increased risk of cancer associated with the drug cannot be ruled out. As a result of these problems, Xolair warning labels will be updated with information about cardiovascular and cerebrovascular adverse events, as well as cancer.
ISMP Report on Xolair Hypersensitivity Reactions
On May 7, 2014, the Institute for Safe Medication Practices (ISMP) released its QuarterWatch report, which monitors adverse event reports and identifies trends among certain drugs’ side effects. According to ISMP, nearly 10% of all serious adverse events reported to the Food & Drug Administration over the previous year involved drug hypersensitivity reactions.
Between March 2012 and March 2013, FDA received information on 13,042 hypersensitivity drug reactions. Of these, approximately 4,045 incidents resulted in serious injury or death, with at least 966 deaths reported. ISMP stated that potential hypersensitivity reactions from Xolair are particularly troubling, indicating that the side effects “were so frequently reported and severe that this risk should be carefully considered in deciding whether clinical use is appropriate.”
Xolair users should continue taking the medication as prescribed. If you feel you may be at risk when using Xolair, or notice any unusual symptoms after being treated with the drug, talk to your doctor right away. Never stop taking a prescription medication without consulting your physician first.
Xolair Side Effects
In addition to being linked to cardiovascular and cerebrovascular injuries, Xolair has been associated with the following side effects:
- allergic reactions
- tightness in the chest
- trouble breathing
- hives or skin rash
- feeling anxious or light-headed
- warmth or tingling under the skin
- swelling of the face, lips, tongue or throat
- tired feeling
- joint or muscle pain
- ear pain
- hair loss
- sore throat or cold symptoms
- redness, bruising, warmth, burning, stinging, itching, pain, or swelling of the skin at the injection site