Every year, countless prescription medications throughout the world hit the market. The majority of these drugs have numerous health benefits, which help patients suffering from a variety of illnesses and conditions. While these prescription drugs aim to aid these patients, there are a handful of prescription drugs that lead to unforeseen outcomes. Some medications can cause serious injuries and, in extreme cases, death. Whenever a prescription medication causes an injury or death, they lead to dangerous drug cases. Wormington & Bollinger has experience handling dangerous drug cases involving many different drugs, including Xeljanz.

Before a prescription can enter the market, the U.S. Food and Drug Administration (FDA) must approve it first. The FDA’s Center for Drug Evaluation and Research (CDER) goes through a thorough process to ensure the drug works the way scientists designed it. While most prescriptions have risks, the CDER makes sure the health benefits outweigh those risks. Through their process, they ensure no dishonest practice went into the creation of a drug. They also provide doctors and patients with information about safely using the medication. However, unforeseen side effects and risks can occur, as is the case with Xeljanz.

Our dangerous drug lawyers understand how devastating these cases can be. After all, you take these medications to help you, only for them to end up hurting you in the end. While the FDA approved Xeljanz to treat a handful of conditions, in recent years, more and more cases involving dangerous side effects have emerged. The FDA released a statement in 2019 warning of the risks. Our attorneys have kept a watchful eye on any new lawsuits. If you or a loved one suffered after being prescribed this drug, contact the Xeljanz attorneys at Wormington & Bollinger today.

What is Xeljanz?

The FDA first approved Xeljanz in 2012 as a treatment for moderate to severe cases of rheumatoid arthritis. Eventually, in 2017, they also approved it to treat psoriatic arthritis and, in 2018, ulcerative colitis. Pfizer manufactured Xeljanz as a Janus Kinase 1 and 3 (JAK) inhibitor. Being an inhibitor means this drug disrupts cell signals in the JAK pathways to reduce the production of cytokines. Your body produces cytokines to help control the immune system. Your body increases its production when you have an infection. However, people with rheumatoid arthritis produce more cytokines than necessary, which leads to inflammation and pain. The drug operates in the same way for people with psoriatic arthritis and ulcerative colitis.

According to the Xeljanz website, 196,130 patients have been prescribed the drug throughout the U.S. 177,560 of those prescriptions were for patients with rheumatoid arthritis, while 9,653 and 8,917 were for psoriatic arthritis and ulcerative colitis respectively. Pfizer reported they made $1.7 billion off the drug in 2018.

Dangerous Side Effects

While the FDA did approve Xeljanz for patients suffering from a handful of conditions, in the years since it hit the market, more cases of dangerous side effects have made themselves known. The drug does treat these conditions effectively, but its side effects may prove to outweigh the benefits. Since the FDA released its statement of its increased risks, lawsuits emerged on behalf of those who suffered. The drug increases the risk of blood clots and death.

There are two kinds of blood clots caused by Xeljanz: pulmonary embolism (PE) and deep vein thrombosis (DVT). Pulmonary embolism is the medical term for a blood clot in the lungs, while deep vein thrombosis is other blood clots that are common in the thighs and lower legs.

Those with PE will experience:

  • Shortness of breath
  • Chest pain
  • Irregular heartbeats
  • Cough
  • Lightheadedness or passing out
  • Back pain
  • Unusual sweating
  • In extreme cases, coughing up blood

Those with DVT will experience:

  • Swelling in the foot, ankle, or leg, typically on one side
  • Cramping pain
  • Severe pain in your foot or ankle
  • An area of your skin that feels warmer than surrounding areas
  • Pale skin or reddish or bluish skin
  • Tenderness

If you experience these symptoms, you must seek medical attention right away. These conditions can be life-threatening if you do not receive proper medical treatment. Doctors may treat these blood clots with medication, compression stockings, and even surgery. Some patients might have to take medication for the rest of their lives to prevent future clots. If Xeljanz was the cause of your blood clot, you may seek compensation for medical bills, both present and future, with the help of the trusted dangerous drug attorneys at Wormington & Bollinger.

Clinical Trials

Around the time the FDA approved Xeljanz, it needed another study to measure the cardiovascular safety of the drug. Pfizer announced in a press release in February 2019 that they would be transitioning rheumatoid arthritis study patients from doses of 10 mg twice daily to 5 mg twice daily. The decision came after the tofacitinib Rheumatology Data Safety Monitoring Board recognized a safety concern with the 10 mg twice a day treatment. Tofacitinib is an active ingredient in Xeljanz.

The board found that patients taking 10 mg of tofacitinib twice a day had an increased risk of pulmonary embolism and death compared to those taking 5 mg twice a day. As we mentioned earlier, the FDA did release a statement shortly after Pfizer did, alerting the public to the trial and its results, which highlighted an increased risk of PE and death.

In July 2019, the FDA approved a black box warning about the increased risk of blood clots. Although the data from this study found risk in people with rheumatoid arthritis, the FDA believes those who take it for ulcerative colitis may also be at risk.

Xeljanz Lawyers

Dangerous drug cases are often devastating. After all, you take these medications to help with a condition or illness, only for it to lead to severe side effects. Many of which can be life-threatening, as is the case with Xeljanz. If you or a loved one suffered after being prescribed this drug, contact the expert dangerous drug attorneys at Wormington & Bollinger. Let us fight for the compensation you deserve.