Exjade Lawyer

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.

If you have experienced severe gastrointestinal (GI) side effects after taking this drug, you should speak to an Exjade lawyer about your rights to demand justice.

History of Exjade

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.  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 a 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.

You should not use Exjade if you have severe kidney or liver disease, advanced cancer, a blood cell or bone marrow disorder or low levels of platelets in your blood. And you shouldn’t use Exjade if you’re allergic to it, or if you have:

  • Severe liver or kidney disease
  • Advanced cancer
  • Bone marrow disorder
  • Low levels of platelets in your blood

Exjade Side Effects and Complications

The drug has been the subject of major controversy once it was discovered that its manufacturer, Novartis Pharmaceuticals, was illegally paying medical professionals to hide dangerous Exjade side-effects from their patients. These previously undisclosed or understated complications include:

  • Renal impairment
  • Hepatic impairment
  • Gastrointestinal hemorrhage
  • Gastrointestinal ulceration
  • Gastrointestinal perforation
  • Severe skin rash/reaction
  • Stevens-Johnson Syndrome (SJS)
  • Toxic Epidermal Necrolysis (TEX)

If you have experienced these or other side effects from Exjade, you should discuss them with a skilled attorney.

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.

Severe Skin Rashes

Rashes may occur during Exjade treatment, according to the U.S. Food and Drug Administration.

For rashes of mild to moderate severity, Exjade may be continued without dose adjustment, since the rash often resolves spontaneously. In severe cases, Exjade may be interrupted.

Reintroduction at a lower dose with escalation may be considered in combination with a short period of oral steroid administration.

The following skin conditions have been reported during Exjade treatment:

  • Stevens-Johnson Syndrome (SJS)
  • Toxic Epidermal Necrolysis (TEX)
  • Erythema multiforme

Stevens-Johnson Syndrome (SJS)

Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis is a severe allergic drug reaction. According to the Stevens-Johnson Syndrome Foundation, the reaction can cause the following symptoms:

  • Painful Blistering of the skin and mucous membrane involvement
  • In many cases, it’s preceded by flu-like symptoms and a high fever
  • As it evolves, the skin literally sloughs off
  • Ocular involvement includes: severe conjunctivitis, iritis, palpebral edema, conjunctival and corneal blisters, and erosions, and corneal perforation

This is not a complete list of side effects and others may occur.

Toxic Epidermal Necrolysis (TEX)

Also known as Lyell’s syndrome, Toxic Epidermal Necrolysis is a rare, life-threatening skin condition that can be caused by a reaction to Exjade. It may occur in all age groups.

It is characterized by blisters that meld into one another to cover a substantial portion of the body, and extensive peeling or sloughing off of skin (exfoliation and denudation). The exposed under layer of skin (dermis) is red and suggests severe scalding.

According to the Stevens-Johnson Syndrome Foundation, the reaction can cause the following symptoms:

  • Skin lesions
  • Skin blisters
  • Mucous membrane lesions
  • Mouth rash
  • Mouth blisters

This is not a complete list of side effects and others may occur.

Treatments for Toxic Epidermal Necrolysis include:

  • Hospitalization
  • Intravenous feeding
  • Medications
  • Oral steroids
  • Antihistamines

Erythema Multiforme

Erythema multiforme is a skin condition considered to be a hypersensitivity reaction to infections or drugs, including Exjade. It consists of a polymorphous eruption of macules, papules, and characteristic “target” lesions that are symmetrically distributed with a propensity for the distal extremities, according to the American Academy of Family Physicians.

The most important treatment is usually symptomatic. Treatments for Erythema multiforme include:

  • Oral antihistamines
  • Analgesics
  • Local skin care
  • Soothing mouthwashes (eg, oral rinsing with warm saline or a solution of diphenhydramine, xylocaine, and Kaopectate)
  • Topical steroids may be considered

For more severe cases, meticulous wound care and use of Burrow or Domeboro solution dressings may be necessary, according to Medscape.

Gastrointestinal Complications

These symptoms can culminate into one of three serious conditions:

  • Gastrointestinal Ulceration
  • Gastrointestinal Hemorrhage
  • Gastrointestinal Perforation

The three aforementioned complications can each lead to serious health consequences that require immediate medical attention.

Gastrointestinal ulceration refers to the development of painful sores or ulcers within the stomach or the surrounding intestines. If left untreated, gastrointestinal ulceration can lead to perforation and bleeding, it is considered especially dangerous in elderly Exjade users.

Gastrointestinal perforation is the occurrence of holes developing in the stomach or intestine area. This condition is life-threatening if not immediately treated by a doctor, with the odds of long-term damage increasing as time passes.

The last of these dangerous conditions is gastrointestinal hemorrhaging. This condition constitutes bleeding that occurs in the intestine area. Even minor bleeding in the intestine area can lead to severe health consequences if left untreated.

If you suspect you are suffering from any of these conditions it is important to immediately contact a medical professional to receive the necessary medical care.

Less Serious Side Effects Of Exjade

RxList lists some of the less serious side effects associated with the use of Exjade, these side effects are:

  • Nausea
  • Vomiting
  • Stomach/abdominal pain
  • Diarrhea
  • Dizziness
  • Anxiety
  • Tired Feeling
  • Sleep Problems
  • Rash
  • Discolored skin
  • Headache/fever
  • Cough
  • Sinus pain
  • Runny/stuffy nose

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.

In November 2015, Exjade manufacturer, Novartis Pharmaceuticals, settled with the United States Federal Government for $390 million.

This settlement was in response to a lawsuit filed by the U.S. Attorney for the Southern District of New York on behalf of over 40 states alleging that Novartis had paid specialty pharmacies and physicians millions of dollars in illegal kickbacks. Reportedly, the illegal payments were used to influence medical professionals to prescribe Exjade to more patients for longer periods of time while understating the dire side effects that could result from the drug use.

Since the settlement was reported, individuals seeking compensation for damages related to taking Exjade have begun filing lawsuits against Novartis with the help of experienced lawyers.

With many of these dangerous drug lawsuits being recently filed, there has yet to be a reported settlement reached between a plaintiff and Novartis Pharmaceuticals. However, the company reportedly hasn’t denied offering illegal kickbacks to cover up Exjade side effects. Lawsuits will not only seek a settlement of compensatory damages but punitive as well — potentially skyrocketing future settlement figures.

Novartis AG, the manufacturer of Exjade, may have withheld information about the risk of renal and hepatic impairment. As a result, the plaintiff(s) could potentially receive compensation, which may include:

  1. Costs of lawsuit incurred
  2. Compensatory and general damages
  3. Punitive damages
  4. Special and incidental damages, including medical expenses and lost wages
  5. Loss of enjoyment of life, pain, and suffering, and disability
  6. Wrongful death damages, if the person died due to this dangerous drug

Contact an Exjade Attorney to Learn More

As an attorney can explain, 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 Hemorrhage
  • Gastrointestinal Perforation
  • Severe Skin Rash/Reaction
  • Stevens-Johnson Syndrome (SJS)
  • Toxic Epidermal Necrolysis (TEX)
  • Erythema Multiforme
  • Death

Our Exjade lawyers can work with you to file a claim if you have suffered gastrointestinal ulceration, hemorrhage, or perforation as a result of ingesting this drug.

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    Sources and References
    1. FDA Approves Exjade to Remove Excess Iron in Patients with Genetic Blood Disorder – FDA
    2. FDA Approves First Oral Drug for Chronic Iron Overload – FDA
    3. Exjade – Official Website
    4. Exjade Side Effects – Drugs.com
    5. What is Exjade? – Exjade Official Website
    6. Boxed Warning for Exjade – American Gastroenteroligcal Association
    7. Novartis Settles $3.3 Billion Lawsuit as Profit Dips – Bloomberg
    8. Manhattan U.S. Attorney Announces $370 Million Civil Fraud Settlement – United States Department of Justice
    9. Novartis Pays $370M for Drug-Pushing Scheme – USA Today
    10. Erythema Multiforme – American Academy of Family Physicians
    11. Lyell’s Syndrome – U.S. National Library of Medicine
    12. Stevens-Johnson Syndrome – Mayo Clinic
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