In early 2019, the U.S. Food and Drug Administration (FDA) released a statement warning doctors, patients, and more about new risks associated with Xeljanz. As with any drug, the FDA has to go through a thorough approval process to ensure a drug works the way the manufacturer designed. In their initial tests, they recognized pre-established side effects that the manufacturer (Pfizer) themselves had identified first.

However, not everything can be known about a drug in the initial testing. The FDA must conduct longitudinal tests to uncover any other issues, which was the case for Xeljanz. Around the time the FDA initially approved Xeljanz in 2012, they began another study to measure the cardiovascular safety of the drug.

The results of their interim analysis of this study in 2019 uncovered that Xeljanz use leads to an increased risk of blood clots and death. Pfizer failed to warn the FDA, doctors, patients, and more about these risks, putting the lives of thousands at risk. In response, the FDA included a black box warning on the drug.

Additionally, this recent discovery has led to a slew of Xeljanz lawsuits emerging against Pfizer for their recklessness. The blood clots in question are dangerous and potentially life-threatening. If you or someone you know suffered an adverse reaction after taking Xeljanz, contact the dangerous drug attorneys at Wormington & Bollinger and let us fight for you.

Xeljanz Side Effects

As we mentioned earlier, Pfizer knew about many potential side effects taking Xeljanz might cause. During the approval process, they provided the FDA with this information. As usual, this information made its way to doctors and pharmacies that also shared it with patients.

Some side effects are far more dangerous than others. Common side effects include:

  • Diarrhea
  • Headaches/migraines
  • Rash
  • Increased cholesterol levels
  • Nausea
  • Vomiting
  • Hypertension
  • Urinary tract infection (UTI)
  • Upper respiratory tract infection
  • Cold-like symptoms

While the above side effects are relatively minor, Xeljanz can lead to more significant side effects, such as:

  • Serious allergic reactions
  • Shingles
  • Anemia
  • Increased risk of bacterial, fungi, or viral infections
  • Pneumonia
  • Cellulitis
  • Certain cancers (such as lymphoma and skin cancer)
  • Gastrointestinal perforations (tears in the digestive tract)
  • Enlarged fatty liver

Any of these side effects can prove life-threatening if you do not seek the appropriate treatment immediately. The sooner you treat yourself, the quicker your recovery will be.

Blood Clots Caused by Xeljanz

While the above side effects were known when the FDA approved Xeljanz, the FDA discovered more adverse reactions after conducting an interim analysis of a study they began in 2012. The result of this analysis found that taking a 10mg dose of Xeljanz twice a day led to increased risks of blood clots and death.

The blood clots in question are pulmonary embolism (PE) and deep vein thrombosis (DVT). While each is a blood clot, they affect different areas of your body. If you are someone who was taking Xeljanz, it is crucial that you understand the dangers that these conditions present.

Pulmonary Embolism (PE) 

Pulmonary embolism is the medical term used to describe a blood clot in the lungs. When your heart pumps blood to your lungs, the blood travels through the pulmonary artery. Once in the lungs, they supply the blood with oxygen, which it then carries back to the heart. The heart will then pump oxygen-rich blood across your entire body.

As you can imagine, this process is vital to the overall health of your body. Unfortunately, blood clots can disrupt this process. When a blood clot gets caught in one of these arteries, it blocks blood from traveling from the heart to the lungs, which is called a pulmonary embolism.

PE can cause significant damage to both your heart and your lungs. The tissues in your lungs suffer from the lack of blood flow, while your blood oxygen levels become increasingly low. If this oxygen-rich blood does not make it to other organs, they can suffer, as well. If the clot becomes big enough or many smaller clots clog the artery, PE can be fatal.

Symptoms of pulmonary embolism include:

  • Shortness of breath
  • Chest pain
  • Irregular heartbeats
  • Coughing
  • Lightheadedness or passing out
  • Back pain
  • Unusual or frequent sweating
  • Fatigue

In extreme cases:

  • Lips and nails turning blue
  • Coughing up blood

Deep Vein Thrombosis (DVT) 

Unlike PE, deep vein thrombosis (DVT) commonly occurs in the thighs and lower legs. Blood is supposed to move throughout your body quickly. Whenever it slows down, it can cause clumps of blood cells to build up, creating a blood clot. When these clots form in veins deep inside your body, it becomes deep vein thrombosis.

Typically, DVT occurs in the lower leg, thigh, or pelvis, but it can happen in various areas in your body. DVT can lead to pulmonary embolism if a blood clot breaks free and moves through the bloodstream into your lungs.

DVT can be extremely dangerous, so it’s vital to recognize the signs and symptoms before it’s too late. Those with deep vein thrombosis might experience:

  • Swelling in the leg, foot, ankle, or arm (usually occurring on one side)
  • Cramping pain
  • Severe pain in the swollen extremities
  • Areas of skin that feel warmer than the surrounding areas
  • Pale skin or reddish/bluish skin
  • Areas of your body that are tender to the touch

You should seek immediate emergency medical care if you begin to experience:

  • Coughing up blood
  • Sharp chest pain
  • Pain in your shoulder, neck, arm, or jaw
  • Unusually sped up or rapid breathing
  • Painful breathing
  • Irregular heartbeat

You can experience upper extremity DVT (blood clots in your arms) that share similar signs and symptoms as lower extremity DVT. Regardless, you should seek medical attention right away if you begin to experience any of these symptoms.

Filing a Xeljanz Lawsuit 

As you can see, the blood clots you can develop after taking Xeljanz can be extremely dangerous. Regardless of if Pfizer was aware of these side effects and did not tell anyone or made an error while developing the drug, they still put thousands at risk.

If you or someone you love fell victim to the adverse reactions of Xeljanz, contact Wormington & Bollinger today. Let us help you recover the damages you rightfully deserve.