Xolair Lawsuits

Philadelphia Defective Drug Attorneys

When the FDA first approved Xolair for the treatment of asthma in 2003, asthma sufferers everywhere were hopeful that this would help them manage their asthma symptoms. It was supposed to be primarily helpful for individuals whose asthma could not be controlled well with inhaled corticosteroids. Now, however, it seems that asthma patients taking Xolair could be at a higher risk for developing heart attacks, strokes, and other life-threatening injuries. This news recently prompted the FDA to begin an investigation into Xolair and its dangerous side effects.

Our national dangerous drug attorneys at Golomb & Honik, P.C. are currently investigating Xolair claims. If you or someone you love has suffered a heart attack or stroke after taking Xolair, call (215) 278-4449 to get your case reviewed for free by one of our attorneys. Fill out a complimentary case evaluation form here.

What is Xolair?

Xolair is a drug prescribed for the treatment of moderate to severe asthma. Patients with asthma produce too much of a specific protein known as IgE. It is believed this protein contributes to a variety of allergic conditions including hay fever, asthma, venom sensitivity, and food or drug allergies. Xolair works by blocking the action of the IgE, thus treating those with asthma.

Xolair is used in adolescents over the age of 12 and adults, and is given via injection in the upper arm, every two to four weeks. According to patient information, it can take several months before patients begin to notice significant benefits from Xolair. Xolair is extremely expensive, costing approximately $2,100 per dose along with an injection fee of about $200. Even those with insurance will likely pay a certain portion of the cost.

Side Effects of Xolair

Xolair contains a black box warning, mandated by the FDA, for the potential risks of anaphylaxis, or severe allergic reaction. The symptoms of anaphylaxis include: tightness of the chest, trouble breathing, wheezing or gasping for air, skin rash, hives, dizziness, warmth or tingling of the skin or swelling of the throat, face, lips or tongue. Anaphylaxis is extremely serious as it can lead to death. Other potentially serious side effects associated with Xolair include bruising easily, unusual bleeding, numbness, or weakness.

Dangers Associated with Xolair

Along with the potential side effects, there are more serious dangers associated with the use of Xolair. The FDA approved Xolair in 2003, and by February 2007, after receiving more than 48 adverse event reports of anaphylaxis, required Novartis and Roche to add a black box warning to the labeling regarding the risks associated with anaphylaxis. The FDA noted a disturbing frequency of anaphylaxis, as well as the risk of a delayed onset of adverse reaction from the drug.

Most recently, the FDA evaluated information from a five-year study and twenty-five clinical trials, which compared Xolair to a placebo. These studies determined Xolair increases the chances of cardiovascular problems, including heart attack, stroke, blood clots, and pulmonary hypertension which can be immediately life-threatening. While the FDA is requiring Novartis and Roche to add these risks to the "adverse reaction" labeling area, a black box warning is not yet mandated.

The FDA has stated that due to certain flaws in how the five-year study was constructed, they cannot make a determination regarding just how serious the cardiovascular risks actually are. As such, they are beginning an investigation into these claims.

There has also been a link established between Xolair and certain types of cancer; in one study approximately one in 200 patients developed prostate, breast or skin cancer. This study was also found to have "flaws," in that the patients were not tested for cancer prior to taking Xolair, so pre-existing cancers cannot be ruled out.

How Our Product Liability Lawyers Can Help

Novartis and Roche brought in more than $1.5 billion last year alone from sales of Xolair, so there is little motivation to engage in clinical trials, which could prove the dangers associated with Xolair. Further, the drug is likely to generate even more revenues as the United States and Europe just approved the drug for use in the treatment of chronic hives.

If you or a loved one has suffered a heart attack, stroke, or cardiovascular injury after using Xolair, it is important to speak to a knowledgeable product liability attorney immediately. At Golomb & Honik, P.C., our Philadelphia product liability lawyers will comprehensively evaluate the specific circumstances regarding your use of Xolair, in order to determine whether you have a viable case against the manufacturers of Xolair. Contact us today at (215) 278-4449.