The Xolair lawsuit claims there is a link between the use of this drug and the increased risk of severe cardiovascular and cerebrovascular issues.
What is Xolair and Why is it Prescribed
Xolair is the proprietary brand name of a prescription drug known as Omalizumab. It is a “humanized antibody.” These are antibodies developed from non-human species that have been genetically modified to simulate those produced by the human immune system. Xolair is derived from DNA taken from the ovaries of the Chinese hamster. It is administered intravenously via injection.
Xolair is approved by the FDA for the treatment of patients 12 years and older with moderate to severe persistent asthma who test positive for year-round air allergens and whose symptoms are not well-controlled by asthma medication. Xolair is also approved for patients 12 years and older with chronic hives (a condition called chronic idiopathic urticaria - CIU) without a known cause and which is not controlled by antihistamine treatment.
Who Produces Xolair and What Do We Know About Them
Xolair is a product of Genentech, Inc., a U.S. subsidiary of Swiss-based pharmaceutical company F. Hoffman-LaRoche AG (Roche). The prescription drug is marketed and sold by Genentech in the U.S. in cooperation with Novartis International AG. At present, these companies hold an exclusive patent on Xolair, and there is no generic version.
Genentech was founded in the late 1970s by Dr. Herbert Boyer, one of the early pioneers in the field of genetic engineering. With headquarters in the San Francisco Bay area, the company was acquired by Roche in 2009. That same year, the New York Times reported that during the debate on health care reform, lobbyists for Genentech had drafted statements on behalf of Congressional members of both parties.
In 2012, Genentech was the defendant in a “whistleblower” case in which a group of researchers claimed to be pressured by Genentech executives to rush through a study and ignore scientific and ethical standards. In 1999, Genentech settled allegations by the federal government that it had promoted “off-label” uses for human growth hormone without FDA approval.
Novartis was founded in 1996 as the result of a merger between Swiss chemical manufacturer CIBA-Geigy and pharmaceutical company Sandoz Laboatories, both of which trace their origins to the mid-18th and 19th Centuries. Sandoz is noted for having been the first to develop lysergic acid diethylamine (LSD) in the 1940s as a psychoactive prescription drug for the treatment of mental disorders as well as the invention of the artificial sweetener, saccharine.
A Wall Street Journal story reported that Novartis failed to report on over 10,000 side effects caused by ten different products over a period of more than a decade – including Xolair.
What Are The Most Serious Side-Effects of Xolair
The most serious side effects from Xolair is an increased risk of severe cardiovascular and cerebrovascular issues, and also anaphylaxis (a serious allergic reaction that can cause the throat to swell, blocking the air passage). Other side effects include severe skin rashes and sudden drops in blood pressure as well as joint and limb pain in a significant percentage of patients. There are reported cases in which such adverse reactions occurred almost immediately after administration of the drug; however these symptoms may appear after as long as twelve months of treatment with Xolair.
Anaphalyxis occurs in approximately 2% of the patients treated with Xolair, and can be potentially fatal. Transient ischemic attacks are particularly dangerous because often there are no immediately apparent symptoms. When present, these symptoms may include difficulty with speech and vision, dizziness and weakness and/or numbness or tingling on one side of the body.
What Does The Government Say About Xolair
In September 2014, the FDA issued a drug safety communication regarding the increased risk of heart and brain blood vessel issues with the use of Xolair. The FDA stated: "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. Although the data are suggestive of a serious safety signal, due to weaknesses in how the safety study was designed and carried out, we are unable to definitively confirm or determine the exact increased level of these risks with Xolair."
The FDA specifically concluded that Xolair was associated with an increased risk of cardiovascular and cerebrovascular serious adverse events, as well as for myocardial infarction, unstable angina, transient ischemic attack, pulmonary embolism/venous thrombosis, and pulmonary hypertension.
Has Xolair Been Subject to a Recall as a Result of Cardiovascular and Cerebrovascular Issues
As of January 2019, there has not been a recall of Xolair related to cardiovascular and cerebrovascular issues. However, in September 2014, the Food and Drug Administration publicly warned that Xolair is linked to an increased risk of heart and brain blood vessel problems.
Government and Scientific Studies Regarding Xolair
2014-September 26: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events: 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. To read more, click FDA Drug Safety Communication