Food and Drug Association (FDA) Issues Warning for Xeljanz Arthritis Medication

The federal government is sounding the alarm for anyone taking Xeljanz or Xeljanz XR.

Earlier this month, the U.S. Food and Drug Administration, or F.D.A. announced a large-scale, randomized review of the medications’ clinical data. Agency analysts found that Xeljanz and Xeljanz XR, used to treat different types of arthritis, may have serious side effects and, in some cases, exacerbate other pre-existing health conditions

While the investigation into Xeljanz is ongoing, scientists recommend that anyone taking Xeljanz or Xeljans XR consult their physician or otherwise seek immediate medical attention. 

What Xeljanz is Used For

Xeljanz and Xeljanz XR are Janus kinase inhibitor-class drugs used to treat rheumatoid and psoriatic arthritis. These medicines have other uses, and are frequently prescribed to people diagnosed with ulcerative colitis. Xeljanz may sometimes be taken by children diagnosed with juvenile idiopathic arthritis, too.

Since arthritides and colitis are caused—at least in part—by over-active immune systems, Xeljanz and similar types of medication help control arthritic conditions by decreasing the body’s immune activity. 

Xeljanz and Xeljanz XR were both approved for use in the United States within the last decade; an estimated 200,000 people have since been prescribed the drugs to treat their arthritis or colitis.

However, while Xeljanz was briefly considered an acceptable alternative to other types of arthritis-control medications, the F.D.A’s analyses have raised big red flags for anyone taking the drug at any dose.

Background on the Dangers of Xeljanz Arthritis Medication

Xeljanz and Xeljanz XR are manufactured by Pfizer. While the medications were approved to treat rheumatoid and psoriatic arthritis in 2012 and 2017, respectively, experts have long had concerns for their safety. The Food and Drug Administration, for instance, mandated that all boxes carry warnings about Xeljanz’s potential side effects, which include injury and even death. European medical councils, similarly, refused to authorize the sale of Xeljanz until 2018, saying they had too many doubts about the product’s efficacy. 

Even after Xeljanz was approved in the United States and Europe, researchers have kept a close eye on what many people suspected was a high-risk prescription.

The F.D.A. has required that Pfizer continue running clinical trials and reporting data to the federal government. 

In 2019, the Food and Drug Administration’s Drug Safety Monitoring Board begin pouring over post-marketing patient trials. These trials, says the F.D.A’s official website, were meant to evaluate the safety of Xeljanz at different doses. 

The F.D.A. quickly realized trial participants taking Xeljanz faced substantial risk compared to control groups prescribed traditional tumor necrosis inhibitors

The F.D.A’s analyses of Pfizer’s post-marketing trials on Pfizer medication Xeljanz showed that:
  • Patients taking Xeljanz or Xeljanz XR are at higher risk for pulmonary embolisms.
  • Xeljanz and Xeljanz XR may contribute to higher patient mortality rates. 
The Risks of Xeljanz

After observing worrying data in Pfizer’s data, the F.D.A began digging deeper. In September 2021, the agency published the latest information on Xeljanz and Xeljanz XR

  • Heart attack
  • Stroke
  • Cancer
  • Blood clots
  • Death 

The same data indicated that even lower doses of Xeljanz may still be unsafe. 

What is the F.D.A Response to Studies Suggesting the Health Risks of Xeljanz?

The U.S. Food and Drug Administration sent out its first warning in 2019. 

Since its findings, the agency has begun taking concrete action to protect Americans from Xeljanz and Xeljanz XR: 

  • Pfizer must brand Xeljanz and Xeljanz XR with updated warnings to let patients know that they may be at higher risk of cancer, blood clots, and death. 
  • The F.D.A. has also asked that health care professionals thoroughly evaluate the benefits and risks of Xeljanz before issuing any new prescriptions. 
  • The F.D.A. has limited Xeljanz and Xeljanz XR’s approved uses to patients who are unable to tolerate or unresponsive to tumor necrosis factor blockers.

Who is at Risk

Xeljanz and Xeljanz XR have the potential to be dangerous—even deadly. 

However, not everyone who takes Xeljanz or Xeljanz XR will experience any negative side effects. This is because no two people respond to treatment in exactly the same way. An individual’s personal health, hygiene, and lifestyle may, alternately, increase or decrease their risk. 

Nevertheless, the Food and Drug Administration recommends caution for anyone who:

  • Smokes or used to smoke
  • Has a history of heart problems (including anyone who has had a heart attack)
  • Has suffered strokes or needed treatment for blood clots

If you fall into one of the F.D.A.’s high-risk categories, you should ask your physician to consider alternatives to Xeljanz.

Knowing When to Get Help for Health Problems Associated with Xeljanz


Anyone who is taking Xeljanz or Xeljanz XR and experiences the symptoms of heart-related difficulties or disease should seek emergency medical attention.

Symptoms of a health problem potentially caused by Zeljanz include:

  • Prolonged, recurring or intense discomfort in the chest
  • Tightness, pain, pressure, or other feelings of abnormality in the chest, throat, neck, or jaw 
  • Pain or discomfort in other parts of the body, but especially its extremities 
  • Unexplained sweating, nausea, or vomiting 
  • Slurred speech, or other verbal confusion 
  • Strange sensations, such as numbness or weakness, that are specific to only one side of the body

These symptoms may be early warning signs of a heart attack, pulmonary embolism, or other potentially life-threatening condition.

You should also request an immediate doctor’s appointment if you have experienced any of the following signs and symptoms: 

  • Swollen lymph nodes in the neck, armpit, or groin
  • Fatigue 
  • Fever
  • Night sweats 
  • Lingering cough 
  • Respiratory difficulties 
  • Unexplained weight loss 

What to Do If You Were Hurt By the Arthritis Medication Xeljanz

Hundreds of thousands of Americans have been prescribed Xeljanz, hoping it would help relieve their chronic pain.

Unfortunately, the F.D.A. has discovered that Pfizer’s Xeljanz and Xeljanz XR medications pose significant health risks.

In fact, the F.D.A. is so concerned about Xeljanz that it has ordered Pfizer to include new warning labels, and restricted the use of Xeljanz to patients who have not responded to, or cannot tolerate, one or more tumor necrosis factor blockers.

The F.D.A. has had concerns about Pfizer for years, while other countries’ health associations expressed doubt about Xeljanz’s safety and efficacy.

When a company injures another person with a faulty product, the injured person can file a personal injury lawsuit demanding damages. The law lets people request damages for many different hardships:

  • Medical bills 
  • Physical pain and suffering
  • Psychological pain and suffering 
  • Lost wages or diminished earing capacity 
  • Wrongful death 
Even people who had a history of heart-related problems before taking Xeljanz may be entitled to funds from an eventual legal settlement.

The Law Protects People Injured By Hazardous Pharmaceuticals Like Xeljanz

Tragically, the thousands of families and people who thought Xeljanz could help alleviate arthritis pain had to wait for the federal government to tell them that Pfizer’s own data showed that Xeljanz and Xeljanz XR are dangerous—even deadly. 

If you or a loved one was injured, you may be legally entitled to money to cover your financial and physical injuries. Speak to a personal injury attorney who can advise you on how to proceed.