Exjade Lawsuits: GI Problems & Skin Rashes
Commonly asked questions about Exjade (deferasirox):
- What is it?
- Can it cause gastrointestinal ulcers, bleeding and perforation?
- Can it cause severe skin rashes?
- Are there lawsuits against it?
- What’s the criteria for filing a lawsuit?
- Can I file a lawsuit?
- How do I start a claim?
What Is Exjade?
Exjade (deferasirox) is an oral iron chelator developed to treat chronic iron overload due to multiple long-term blood transfusions, which are necessary to treat conditions such as beta-thalassemia and other chronic anemias.
An estimated 1,000 people in the United States have thalassemia, according to the National Heart, Lung, and Blood Institute.
Thalassemia conditions can cause the body to make fewer healthy red blood cells and less hemoglobin, a protein that carries oxygen to all parts of the body and returns carbon dioxide to the lungs so it can be exhaled. Patients with thalassemia often require transfusions of red blood cells to maintain an acceptable level of hemoglobin.
Iron overload is common in these patients.
It was officially approved by the U.S. Food and Drug Administration on November 9, 2005, becoming the first orally administered medication to be approved for this use.
The controversial drug was also approved under the FDA’s accelerated approval program, which allows the agency to approve products for serious or life-threatening diseases based on early evidence of the product’s effectiveness.
In January 2013, the FDA expanded the approved use of the drug to treat patients, ages 10 years and older, who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).
NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions. However, over time, some patients with NTDT are still at risk for iron overload that can lead to damage to vital organs, the agency said in a released statement.
During a 48-week clinical study, Exjade — which reportedly generated $531 million in sales in 2008 — demonstrated reduction in liver iron concentration in adult and pediatric patients receiving red blood cell transfusions on an ongoing basis.
Manufactured by Novartis Pharmaceutical Corp. in Switzerland, Exjade received Orphan Drug Designation, which is granted to products that treat diseases affecting fewer than 200,000 people in the U.S. The Orphan Drug Act provides a seven-year period of exclusive U.S. marketing to the first sponsor that obtains marketing approval for a designated orphan drug.
In post-marketing experience, there have been reports of serious adverse reactions, some with a fatal outcome, in patients taking Exjade therapy.
Common side effects include nausea and abdominal pain. Elevations in blood tests that measure kidney and liver functions were also noted in clinical studies. Less common side effects included hearing and visual disturbances and rashes.
Can Exjade Cause GI Ulcers, Bleeding and Perforation?
It has been linked to several serious side effects, including renal impairment (including failure), hepatic impairment (including failure) and gastrointestinal hemorrhage.
In 2009, it was ranked No. 2 on the list of “Most Frequent Suspected Drugs in Reported Patient Deaths,” according to the Institute for Safe Medical Practices.
Cases of hepatic failure — including some with a fatal outcome — have been reported internationally following post-marketing use. Most of these cases reportedly involved patients with significant co-morbidities, including liver cirrhosis and multi-organ failure, according to the Public Health Agency of Canada.
Additionally, there were post-marketing reports of cytopenias, including agranulocytosis, neutropenia and thrombocytopenia in patients treated with the drug where some of the patients died. Cases of leukocytoclastic vasculitis, urticaria, and hypersensitivity reactions were also reported.
The controversial drug has also been linked to fatal gastrointestinal hemorrhages, particularly in elderly patients who had advanced hematologic malignancies and/or low platelet counts. Most of these deaths occurred within six months of initiation and generally involved worsening of the underlying condition.
Non-fatal upper gastrointestinal irritation, ulceration and hemorrhage have also been reported in patients, including children and adolescents.
It is not recommended to use it in combination with drugs that have ulcerogenic or hemorrhagic potential, such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates or anticoagulants.
Can Exjade Cause Severe Skin Rashes?
Rashes may occur during treatment, according to the U.S. Food and Drug Administration.
For rashes of mild to moderate severity, it may be continued without dose adjustment, since the rash often resolves spontaneously. In severe cases, it may be interrupted.
Reintroduction at a lower dose with escalation may be considered in combination with a short period of oral steroid administration.
Erythema multiforme has been reported during treatment.
Are There Lawsuits Against Exjade?
Novartis AG, the drug manufacturer, recently agreed to pay $390 million to resolve a lawsuit that it paid specialty pharmacies illegal kickbacks in exchange for inducing patients to refill certain medications, according to an accord announced in late November.
According to Reuters, the settlement between Novartis, the federal government and more than 40 states concerns payments that the drug manufacturer paid between 2007 and 2012 to certain specialty pharmacies to entice them to recommend prescriptions to Medicaid and Medicare patients.
The federal part of the case reportedly involved six drugs, including Exjade. The U.S. initially sought as much as $3.3 billion from Novartis.
In the settlement, Novartis reportedly admitted to a series of facts detailing its relationship with specialty pharmacies and how the alleged scheme worked.
What’s the Criteria for Filing an Exjade Lawsuit?
A person may be eligible to file a lawsuit against Novartis Pharmaceutical Corp., the drug manufacturer of Exjade, if he/she experiences one or more of the following injuries within 48 hours of using the medication:
- Gastrointestinal Ulceration.
- Gastrointestinal Hemmorhage.
- Gastrointestinal Perforation.
- Severe Skin Rash/Reaction.
- Stevens-Johnson Syndrome (SJS).
- Toxic Epidermal Necrolysis (TEX).
Can I file an Exjade lawsuit?
Our dangerous drug lawyers can help if you or someone you care about has suffered gastrointestinal ulceration, hemorrhage or perforation as a result of ingesting Exjade. Lawsuits have been filed against the drug manufacturer for failure to adequately research or warn about the risk of health problems. Both patients and their families are seeking compensation for injuries. You may be entitled to a settlement if you were harmed by this controversial dug.
Our No-Fee Promise On Exjade Complication Cases
You can afford to have our great team of lawyers on your side. If you choose us, it literally costs you nothing to get started. We promise you in writing:
- No money to get started
- We pay all case costs and expenses
- No legal fees whatsoever unless you receive a Exjade settlement
- Phone calls are always free
How do I start an Exjade claim?
Our gastrointestinal problem lawyers will help you file your lawsuit. To get started, you can:
- Submit the Free Case Review Box on this page, or
- Call 1-866-280-4722 any time of day to tell us about your case.
We will listen to your story and answer your questions. If you have a claim, we will start immediately.
WARNING: There are strict time deadlines for filing Exjade lawsuit claims.