Every year, the U.S. Food and Drug Administration (FDA) approves countless new drugs to enter the market. These drugs have to go through an arduous development process that often takes years. Once the manufacturer has designed a medication, they must send it to the FDA for approval. It will then go through a thorough approval process to ensure the drug is safe and does what it was designed to do. They must also make sure the benefits outweigh the risks.

The FDA first approved Xeljanz in 2012 as a treatment for rheumatoid arthritis. Since its initial approval, the FDA has added to the list of conditions Xeljanz treats. They approved the drug for psoriatic arthritis (PS) and ulcerative colitis (UC) in 2017 and 2018, respectively. Most recently, in September 2020, the organization approved Xeljanz for active polyarticular course juvenile idiopathic arthritis (pcJIA) in children and adolescents two years old and younger.

Furthermore, Pfizer (Xeljanz’s manufacturer) is currently pushing for its approval for ankylosing spondylitis (AS). As you can see, even with the recent release of the FDA’s interim analysis, the list of conditions Xeljanz treats continues to grow.

While Xeljanz is an approved drug, Pfizer currently faces many dangerous drug cases due to adverse reactions leading to significant injury and even death. If you or a loved one suffered injuries while taking Xeljanz, contact the dangerous drug law firm at Wormington & Bollinger and let us fight for you.

Approved Uses of Xeljanz 

As we mentioned earlier, there are many conditions Xeljanz treats. Currently, the FDA has only approved the drug for four different conditions, but Pfizer is making a push for its approval for others.

Tofacitinib (the active ingredient in Xeljanz) belongs to a class of drugs known as JAK inhibitors. These inhibitors work by modifying the underlying condition rather than treating the symptoms. They aim to reduce inflammation and swelling in joints by disrupting the message pathways from immune cells.  The overproduction of cytokines (proteins that help manage your immune system) is what leads to inflammation and pain.

Many of these conditions affect the body in similar ways. But how do they differ from one another? Today, we will review the conditions Xeljanz treats and how much they have in common.

Rheumatoid Arthritis (RA) 

The first disease the FDA approved Xeljanz for was rheumatoid arthritis (RA). RA is an autoimmune disease that leads to joint pain and damage throughout your entire body. You can experience symptoms on either side of your body in small or large joints. In some cases, it can affect other areas of the body, such as the eyes, skin, lungs, heart, and blood vessels.

RA occurs when the body’s immune system starts attacking the synovium. The synovium is the inner lining of the joint that produces fluids to lubricate the joints. It cushions the joints and allows them to move smoothly.

As the immune system attacks the synovium, it inflames and thickens, which causes it to wear away at the cartilage and bone in and around the joint. The surrounding tissue and ligaments then weaken and stretch, causing the joint to lose its shape and alignment.

Common symptoms for RA (as well as the other three conditions) include:

  • Joint pain
  • Tenderness
  • Warm to the touch
  • Swelling
  • Stiffness
  • Reduced range of motion
  • Deformities
  • Fatigue
  • Fever

Typically, smaller joints in your hands and feet develop arthritis first. As it progresses, RA spreads to larger joints in the wrists, hips, knees, ankles, and shoulder. Symptoms may vary and may even come and go, as individuals suffer from periods of flares and relative remission.

Psoriatic Arthritis (PA) 

Psoriatic arthritis (PA) is a form of arthritis that occurs in those with psoriasis (a skin condition characterized by red, scaly rashes on the skin). 30% of people with psoriasis also have PA. Typically, joint problems occur after skin patches have already appeared.

Much like RA, psoriatic arthritis occurs when the body’s overactive immune system begins to attack its own healthy cells and tissues. As the immune system attacks the tissues in your joints, they become inflamed, leading to joint pain, stiffness, and swelling.

While PA shares most of the same symptoms as RA, the difference between the two is that those with PA also experience the red, scaly rash caused by psoriasis. It can affect all parts of your body, from small joints to large ones. As with RA, both PA and psoriasis get worse over time, but you might experience times of remission or periods where symptoms are worse.

However, those with PA are more likely to experience:

  • Swollen fingers and toes
  • Foot pain
  • Lower back pain
  • Skin rashes

Ulcerative Colitis (UC)

Ulcerative colitis (UC) differs from RA, PA, and JIA. While UC is an inflammatory disease, it is not a form of arthritis. Instead, UC is an inflammatory bowel disease (IBD). It causes inflammation and ulcers in the digestive tract, namely the inner lining of your large intestine (colon) and rectum. Symptoms gradually develop over time.

As is the case with RA and PA, healthcare experts do not know why ulcerative colitis occurs. Diet and stress don’t cause UC, but they can aggravate the condition. Another theory is an issue in the immune system that causes the immune system to abnormally attack the cells in the digestive tract when fighting off invading bacteria and viruses.

Common symptoms of ulcerative colitis include:

  • Abdominal pain
  • Increased abdominal sounds
  • Bloody stools
  • Diarrhea
  • Fever
  • Rectal pain
  • Weight loss
  • Malnutrition
  • Dehydration
  • Loss of appetite
  • Fatigue
  • Joint pain, swelling, and tenderness
  • Frequent emptying of bowels, including in the middle of the night

Juvenile Idiopathic Arthritis (JIA) 

The FDA last approved Xeljanz for active polyarticular course juvenile idiopathic arthritis (pcJIA) in children and adolescents two years old and younger. Typically, when people think about arthritis, they imagine older adults. However, elders are not the only ones who can suffer from arthritis. Young children can develop this autoimmune disease, too.

Juvenile idiopathic arthritis (JIA) affects roughly 300,000 children under the age of 16 every year. However, there are several forms of JIA, which include:

  • Systemic
  • Oligoarticular
  • Polyarticular
  • Enthesitis-related
  • Psoriatic
  • Undifferentiated

The FDA approved Xeljanz to treat polyarticular juvenile idiopathic arthritis (pcJIA). Patients with pcJIA experience arthritis in five or more joints, in either small joints in their hands and feet or large joints in knees, hips, and ankles. This form of JIA affects 25% of all cases.

The immune system of patients with pcJIA attacks the body’s cells and tissues (mostly in the joints) instead of fighting off foreign substances. When this occurs, the body releases an inflammatory chemical that attacks the synovium. Once inflamed, the patient experiences joint pain, tenderness, swelling, and difficulty moving.

Healthcare experts are unsure of what causes children to develop JIA. One theory is that specific genes activate when certain bacteria or stimuli enter the body, but little is known.

Contact Wormington & Bollinger

All drugs must go through a lengthy and thorough approval process before they enter the market. This process ensures that each drug does as it should and that its benefits outweigh the risks. There are now four conditions Xeljanz treats, with more potentially on the way. However, this drug is not without its risks.

In early 2019, the FDA released the findings of its interim analysis. These results revealed that a twice-daily 10mg dose of tofacitinib led to an increased risk of blood clots and death. Naturally, many patients were furious and filed dangerous drug cases against Pfizer for the damages this drug caused. If you or someone you loved suffered injuries while taking Xeljanz, contact Wormington & Bollinger today and let us fight for the justice you deserve.