The FDA recently issued a warning on the popular asthma drug Xolair (omalizumab) after numerous studies found safety problems with the drug. After reviewing these studies, the FDA released an alert on the increased risk of heart and brain issues in patients. Dangerous drug attorneys at Pintas & Mullins Law Firm detail these studies and what they mean for patients.
Xoliar is an injectable drug for asthma patients over the age of 12, whose symptoms cannot be controlled with inhaled drugs. According to the FDA’s safety alert (here), the drug can narrow blood vessels that supply blood to the brain and heart, potentially causing heart attacks and strokes. Xolar’s labels were recently updated to reflect this particular risk.
Experts are also concerned about the possibility of cancer development in Xolair patients, however these risks have not been fully studied. The FDA did note that it could not rule out a potential cancer risk for this drug. The drug was approved in 2003, leaving the long-term effects unknown. The cancers most associated with Xolair are of the prostate, skin, and breasts.
The possibility of cancer was raised because of Xolair’s reaction with the antibody human immunoglobin E (IgE). Xolair works by blocking IgE from causing an allergic reaction, however, IgE also plays an important role in the body’s ability to recognize cancer cells. This suggests that, by blocking IgE, Xolair may also be blocking the immune system from attacking cancer cells.
Xolair’s packaging contains what is known as a “black box warning,” which is the most severe warning from the FDA. Drugs with black box warnings can reasonably cause permanent or fatal injuries in patients. Among the side effects listed on Xolair’s black box labelling is the possibility of anaphylaxis, or severe allergic reaction.
Some experts estimated that nearly one in five patients taking Xolair will suffer an allergic reaction, which would occur two to 24 hours after a Xolair dose. Signs and symptoms of anaphylaxis include:
â¢ Trouble breathing caused by narrowed airways â¢ Dizziness or fainting â¢ Swelling of the tongue or throat â¢ Chest tightness â¢ Hives or rash â¢ Drop in blood pressure â¢ Itching
It is important to note that an allergic reaction can occur even in patients who have taken Xolair in the past without side effects.
The FDA recommends that doctors who prescribe Xolair should observe their patients for at least two hours following a dose. Doctors, patients and families should be prepared to manage life-threatening reactions after taking the drug. The federal agency started investigating Xolair’s safety in 2009, after several studies linked the drug to cardiovascular and cerebrovascular problems.
At this point in time, patients injured from Xolair need to file lawsuits against the manufacturer, Geenentech, on an individual basis. Often times, with drugs that can cause injuries as severe as Xolair, class action lawsuits are filed against the manufacturer. This is possible only when there is an extraordinarily large amount of plaintiffs who suffered the same or similar injuries from a certain drug or product. One of the most well-known drug class actions was against diet drug Fen-Phen, which was taken by at least 7 million Americans. In 2012, Fen-Phen’s manufacturer settled more than 50,000 lawsuits for about $3.75 billion.
Dangerous drug attorneys at Pintas & Mullins Law Firm are currently investigating cases of serious injury in those who have taken Xolair. We accept clients from all 50 states, and investigate each case free of charge. Our firm works on what’s known as a contingency basis, meaning we do not charge by the hour, and are only paid if we are successful in your case, winning you a favorable settlement or verdict. If you have any questions about Xolair, our firm, or any other defective drug, contact our firm immediately for a free case review.