FDA Demands Cardiovascular Warnings on Xolair

FDA Demands Cardiovascular Warnings on Xolair

Posted By Golomb & Honik || 16-Dec-2014

The FDA has-once again-expressed concern over the potential cardiovascular risks associated with the drug Xolair. Xolair is an asthma drug, which has been on the market since it received FDA approval in 2003. The drug is manufactured and marketed by Genentech and Novartis, and currently makes over $1.5 billion each year. Xolair is administered via injection every other week, and used in place of steroid asthma inhalers.

Why is Xolair Still Being Marketed?

It is puzzling that Xolair is still on the market, still be used by asthma patients and still bringing in staggering amounts of money for the manufacturer, when as far back as 2009 the FDA indicated worry regarding the risks of heart attack and strokes in those taking Xolair. In September 2014, the FDA took further action, adding new warnings to Xolair's product labeling which confirms the drug is associated with increased cardiovascular risks. While the warnings are not contained in a black box warning, they are listed in the adverse reaction section of the labeling, which is at least a step in the right direction. Xolair has a prior black box warning from 2007 that relates to the high risk of anaphylaxis, which can be extremely dangerous or even deadly. At least 48 adverse event reports related to anaphylaxis among those taking Xolair are documented.

Is Corporate Greed Trumping Patient Safety?

The source of the new warnings is data from a five-year study, along with twenty-five additional trials, which compared Xolair to a placebo. The trials and study determined Xolair raises the risk of heart attack, chest pain, pulmonary hypertension, heart attack, and blood clots. Unfortunately, due to the specific manner in which the five-year study was designed, the FDA is unable to say just how big those risks really are. While this, in itself, will certainly not make patients feel very secure about taking Xolair, the drug recently gained approval in Europe and the United States to treat chronic idiopathic urticarial-a skin condition marked by chronic hives. This latest approval for the use of Xolair prompted Novartis to predict its dermatology division would soon be bringing in more than $2 billion in annual sales.

Does Xolair Cause Cancer?

The risks of Xolair anaphylaxis was known prior to the drug's FDA approval; in pre-marketing clinical trials, serious anaphylaxis occurred in approximately one out of every 1,000 patients, yet despite the risks, Xolair was allowed on the market. There has also been concern related to the correlation between Xolair and certain types of cancer. Prior to approving Xolair for use in the United States, the original FDA safety officer's report included the wording, "Comparisons of malignancy rates suggest-but do not establish-an increased rate for Omalizumab (Xolair)-exposed subjects." Apparently one clinical study showed the subjects taking Xolair experienced more malignancies than the control group. Cancers were seen in one out of every 200 subjects treated with Xolair-primarily breast cancer, skin cancer and prostate cancer.

National Dangerous Drug Lawyers

You have a right to seek justice if you or someone you love has sustained a heart attack or been diagnosed with cancer after taking Xolair. Drug companies who routinely put profits before people should pay for their negligence-and their unscrupulous behavior. To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

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