Exjade is the brand name drug made by Swiss pharmaceutical company Novartis with the generic name deferasirox. It is known as an oral iron chelator because it attaches to iron in the blood and is used to treat excess iron, also known as iron overload. This is caused by having multiple blood transfusions and can be serious if not treated, including causing cirrhosis of the livre, diabetes, and arthritis, among other complications.
Novartis got approval for Exjade through the U.S. Food and Drug Administration (FDA) in 2005. Since then there have been updates to the safety warnings, including a black box, the most serious of all FDA warnings. It is now known that Exjade may cause serious damage to the kidneys, liver, and gastrointestinal system. Because these warnings were not made until years after the drug came on the market, Novartis could be facing lawsuits from patients harmed by it.
About Exjade and its Uses
As an oral iron chelator, Exjade attaches to iron in the blood for the purpose of removing it from the body. As the body excretes the medicine, the excess iron goes with it. The FDA first approved Novartis’s medication in 2005 for just one indication. It was approved to treat iron overload in patients who had received multiple blood transfusions. Iron overload is fairly common in patients who need blood transfusions to treat other conditions and can have serious complications if not treated. Exjade was the first oral medication approved in the U.S. to treat iron overload.
Later, the FDA approved Exjade for other uses as well, including the treatment of non-transfusion-dependent thalassemia, NTDT, conditions in people ten years of age and older. To use Exjade for this reason, the iron levels in the blood must meet a certain threshold. One NTDT condition is a genetic illness called hereditary haemochromatosis.
The most commonly reported side effects of Exjade are nausea, vomiting, diarrhea, abdominal pain, and rashes, as well as increased serum creatinine in patients being treated for iron overload caused by blood transfusions. In patients using the drug because of an NTDT condition the most common side effects include nausea, diarrhea, and skin rashes. An allergic reaction is possible in some people and is characterized by hives, trouble breathing, swelling in the face, throat, hands, feet, or legs, and itchy rashes on the skin. This reaction should be treated as an emergency.
Kidney Damage and Failure
Although Exjade came out in 2005 it wasn’t until 2010 that the FDA issued a warning about potential severe consequences of using the drug. The agency required an update to the labeling information for Exjade at that time that included a black box warning for three serious side effects, kidney damage, liver damage, and gastrointestinal hemorrhages.
In addition to the black box warning about kidney damage, which can be serious enough to lead to kidney failure, the updated Exjade insert also warns that patients with kidney problems should not be using the drug. If serum creatinine levels are too high, the drug is contraindicated. These levels, when elevated, indicate that the kidneys are not functioning normally. Furthermore, patients using Exjade should have these levels monitored regularly. Patients should also watch out for signs of kidney damage, including a decrease in urine output, shortness of breath, fatigue, confusion, nausea, and swelling in the feet, ankles, or legs.
The black box warning also indicates that Exjade can be toxic to the liver and cause damage and even failure. Signs of liver damage that patients should watch out for include swelling in the feet or legs, pain and swelling in the abdomen, yellowing of the skin or whites of the eyes, dark urine, itchy skin, chronic fatigue, loss of appetite, vomiting, and nausea. Patients using Exjade should be monitored regularly for liver function.
Another black box warning for Exjade is the possibility of a gastrointestinal hemorrhage. The risk includes both non-fatal and fatal instances of hemorrhaging, or bleeding. This kind of bleeding is a greater risk for any patient using certain medications concurrently: blood thinners, aspirin, nonsteroidal anti-inflammatory medications, oral steroids, and medications used to treat bone loss and weakness.
Signs of gastrointestinal hemorrhage should be taken seriously and reported immediately. They include unexplained bleeding or bruising, vomit with blood or what looks like coffee grounds, blood in the stool or black and tarry stool. This kind of bleeding can quickly escalate and lead to death, so patients must carefully monitor their symptoms and avoid the kinds of drugs that increase the risk of bleeding.
Severe Skin Reactions
Another potential problem with using Exjade was added in 2013. The FDA warned that the drug can cause severe skin reactions, including a condition known as Stevens-Johnson syndrome. This warning is not included in the black box, but it is still serious. A skin rash was already known to be a potential side effect of Exjade, but it wasn’t until years later that research found that this severe form of skin rash was also possible.
Stevens-Johnson syndrome is rare, but it is serious and it affects both the skin and mucous membranes. Most often it is caused by a medication. Symptoms of the syndrome often begin with those that resemble the flu, but are then followed by a red and purple rash that is very painful and spreads over the body before blistering. The condition usually requires that a patient be hospitalized for treatment and recovery from it can last for months.
Because Exjade has the potential to cause such serious and devastating, even fatal side effects and complications, lawsuits may be brought by individual patients. Novartis did not include warnings about these problems when the drug first came on the market and if it can be shown that they knew there may be these risks, patients affected could have strong cases against the companies.
One lawsuit has already been filed against Novartis over Exjade and it ended in a big payout. The suit was brought by a whistleblower and the company was charged by the U.S. and state governments with violating the False Claims Act. The claims against Novartis were that the company defrauded Medicare and Medicaid by paying pharmacies kickbacks to recommend Exjade and other drugs to patients and doctors. Kickbacks like this are illegal because they lead to a greater demand for a drug and more prescriptions that may not be necessary. When patients are prescribed drugs that are not necessary, they are put at risk for serious side effects that could have otherwise been avoided.
The drugs involved in the case, including Exjade, cost upwards of $11,000 per month. For many patients, this cost was covered by the federal programs Medicare and Medicaid, and so the kickbacks that led to more prescriptions are considered fraud. Evidence in the case showed that Novartis started up the kickbacks program in 2007 in response to lower than expected sales. Patients were not refilling Exjade at the rate the company had hoped, largely due to the side effects it caused. Novartis ended up being forced to pay out $390 million, the most ever paid solely for kickback schemes.
If you have taken Exjade and suffered from some of the terrible side effects that were not initially included in packaging information, you may also have a case against Novartis. Let a lawyer help you make a case, decide what steps to take and determine what kind of compensation you may be able to seek.