Xeljanz has been on the market for nearly ten years. The U.S. Food and Drug Administration (FDA) first approved the drug for rheumatoid arthritis in 2012. Since that initial approval, the FDA approved Xeljanz for psoriatic arthritis (PA) and ulcerative colitis (UC) in 2017 and 2018, respectively. Most recently, the FDA approved Xeljanz for active polyarticular course juvenile idiopathic arthritis (pcJIA) in 2020.
As is the case with all prescription drugs, Xeljanz is not free of side effects. When seeking approval, drug manufacturers must provide the FDA with the results of their own testing and clinical trials, which include side effects. Unlike the increased risk of blood clots (which was not discovered until after the FDA’s approval), liver damage was a known potential side effect of taking the drug.
Your liver is one of the most vital organs in the body. When there are any issues, you should always take them seriously. Prior to and after the FDA’s approval, healthcare experts have discovered connections between Xeljanz and liver damage.
Nobody expects their prescriptions to cause them any injury. While every drug comes with minor side effects, no one expects to suffer potentially life-threatening injuries while taking a prescription. Unfortunately, cases like this happen far too often. If you or someone you love sustained injuries while taking Xeljanz, contact Wormington & Bollinger today and let us fight for the justice you deserve.
Xeljanz’s Effect
Xeljanz affects the body in a myriad of ways. The active ingredient in Xeljanz is tofacitinib, which is a JAK inhibitor. These inhibitors are disease-modifying antirheumatic drugs (DMARDs), meaning instead of treating the symptoms, they modify the underlying condition.
JAK inhibitors aim to reduce inflammation and swelling in the joints, which relieves joint pain and stiffness. The bodies of those with an overactive immune system (those living with RA, PA, UC, etc.) produce an excessive amount of cytokines (a naturally occurring protein that helps regulate the immune system).
Your body increases the production of these proteins when it detects an infection or inflammation. Unfortunately, for those living with an anti-inflammatory disease (such as RA, PA, or UC), their bodies produce far too many cytokines. This overproduction eventually leads to inflammation, joints stiffness, and chronic pain.
Tofacitinib works by disrupting the signal sent from receptors on immune cells, preventing more cytokines from being produced. JAK inhibitors (including tofacitinib) calm your body’s immune system, which reduces inflammation and pain in your joints.
However, calming the immune system has other effects on the other organs in this system, such as your liver.
Xeljanz’s Effect on Your Liver
Your liver is your body’s largest solid organ, weighing nearly three pounds and containing around a pint (13%) of your body’s blood. It plays an integral role in your body’s metabolic, detoxification, and immune system functions. Without your liver, you cannot survive.
Because Xeljanz works by disrupting your body’s immune system, naturally, it can also impact your liver. The liver is full of activated immune cells. Its principal task is to ensure the peripheral immune tolerance of your body. It also takes part in fighting off infections by producing immune factors and removing bacteria and other toxins from your bloodstream. As you can see, your liver plays an integral role in your immune system.
The risk of liver damage while taking Xeljanz increases significantly if you also take it with the drug methotrexate or heavily abuse alcohol.
Research on Xeljanz and Liver Damage
During clinical trials for Xeljanz, healthcare experts monitored serum enzyme levels in participants, which include:
- Alanine transaminase (ALT)
- Aspartate transaminase (AST)
- Bilirubin
Doctors use these serum enzymes as biomarkers to determine healthy livers. Whenever these levels increase or decrease, it notifies doctors that something might be wrong with your liver.
In a post hoc study, researchers analyzed 25 different clinical trials and other medical studies that involved Xeljanz. The study compared the serum enzyme levels (ATL, AST, and bilirubin) of those taking Xeljanz to those taking a placebo, observing whether these levels were above the upper limits of normal (ULN) or more than three times the ULN. This study found strong indications that Xeljanz was connected to liver damage.
Further studies also found startling connections between Xeljanz and liver damage. In one clinical trial, the results show that just 4% of those taking a placebo had ALT reading higher than the ULN, while 19% of those taking Xeljanz had readings above the ULN. Additionally, 3% were more than three times higher than the ULN.
In another trial, researchers found that those taking higher doses of Xeljanz were increasingly more likely to have ALT levels more than three times higher than the ULN.
Essentially, Xeljanz can affect the way certain enzymes in your liver work. When these enzyme levels change or how they function changes, it can lead to significant liver damage. Because your liver is vital to your body, any damage can lead to long-term complications.
According to Pfizer, if you carry the virus for Hepatitis B or C (viruses that affect the liver), this virus might activate while taking Xeljanz. Your doctor should take blood tests before and during treatment with Xeljanz to monitor your liver and ensure it suffers no damage.
Contact Wormington & Bollinger
While the FDA has approved Xeljanz for a number of conditions, it still has plenty of side effects that you should be aware of, just like any drug. Unfortunately, one potential side effect of Xeljanz is liver damage. Your liver is one of the most vital organs in your body. If an issue arises in your liver, you could experience significant and long-term complications.
If you or a loved one suffered injuries while taking Xeljanz, contact the dangerous drug attorneys at Wormington & Bollinger today. We will help you navigate this process and find you the best course of action to take.