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New Health Warnings Issued For Xeljanz

What You Need to Know About the Health Dangers of Xeljanz

Xeljanz and Xeljanz XR are arthritis medications manufactured by the pharmaceutical company Pfizer. They are known as Janus kinase inhibitor-class drugs². The only difference between Xeljanz and Xeljanz XR is how long their effects last.

Xeljanz and Xeljanz XR are used to treat conditions such as:

• Rheumatoid arthritis

Rheumatoid arthritis is inflammation of the joints, especially the hands and feet.

• Psoriatic arthritis

Psoriatic arthritis is inflammation that affects people with the skin condition psoriasis.

• Juvenile idiopathic arthritis

Juvenile idiopathic arthritis is a type of joint pain and inflammation affecting teens.

• Ulcerative colitis

Ulcerative colitis is a disease causing inflammation in the digestive tract.

These medicines have other uses, too, but are primarily designed to control and alleviate the symptoms of arthritides.

Health Problems of the Immune System

Conditions like arthritis and ulcerative colitis are often caused in part by an overactive immune system.

For example, people who have rheumatoid arthritis produce more cytokine proteins (used to fight infection) than the body needs.

When this happens, the immune system may begin working against the body, sending cytokines to attack connective tissues.³

That’s what causes the inflammation and pain associated with rheumatoid arthritis.

How Xeljanz Works

Xeljanz helps moderate the body’s immune response by limiting the proteins’ ability to send signals to the body. This helps prevent or reduce the inflammation and flare-ups of arthritis.⁴

The Problem with Xeljanz

Xeljanz and Xeljanz XR were first approved for use in the United States in 2012 and 2017, respectively.⁵

However, experts have long had concerns about their safety.

Even after the U.S. Food and Drug Administration let Pfizer begin selling Xeljanz, it required that the medicine feature labels warning consumers of its potential to cause serious injury and death.

After Xeljanz was approved, the F.D.A. instructed Pfizer to continue reporting safety data.

This data was monitored and cross-checked by the federal government.

The dangers of Xeljanz were discovered by an FDA health study.

In 2019, the F.D.A. performed a randomized, large-scale analysis of Pfizer’s post-marketing clinical safety data.

The data from the FDA’s study showed that trial participants treated with Xeljanz were more likely to experience “heart-related events” compared to people who are treated with conventional tumor necrosis inhibitors.

The F.D.A. began recommending that some people avoid Xeljanz.

The Potential Dangers of Xeljanz 

Earlier this month, the F.D.A. issued another, more comprehensive report outlining the potential dangers of Xeljanz. 

The FDA report on Xeljanz advises that people who take the drug are at higher risk of experiencing heart problems including, but not limited to:

• Heart attack

• Stroke

• Cancer

• Blood clots

• Death

However, even people who take lower doses of Xeljanz or Xeljanz XR are still at higher risk for heart-related problems than patients taking other types of medication.

FDA warnings about the dangers of the arthritis medication Xeljanz. 

The F.D.A.s’ warning applies to everyone who has taken or continues to take any of the following drugs:

• Xeljanz (Pfizer)
• Xeljanz XR (Pfizer) 
• Olumiant (Eli Lilly and Company) 
• Rinvoq (AbbVie)

Determining Your Risk Before Taking the Arthritis Medication Xeljanz

Most people who take Xeljanz or Xeljanz XR will never experience any noticeable side effects.

However, no two people react to any medication the exact same way.

In addition, Xeljanz’s most dangerous side-effects are heart-related, and they may not be noticeable until it is too late.

While it is difficult to predict who will experience heart-related problems after taking Xeljanz, the F.D.A. has advised extreme caution for anyone who:

• Smokes or used to smoke

• Has had a heart attack

• With a history of other heart problems

• Has suffered strokes or needed treatment for blood clots⁶

Knowing When to Get Help for Health Problems Associated with Xeljanz

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. They put their faith in Pfizer, trusting the company would design a safe product.

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.

Compensation for Injuries Caused By the Arthritis Medication Xeljanz

If you or a loved one have experienced side effects—or worse—after taking Xeljanz, you should not have to bear the physical, emotional, and financial burden of Pfizer’s mistakes.

Legal Liability for Pharmaceutical Products Like Xeljanz

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 

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.

A Texas Personal Injury Law Firm That Knows What You’re Up Against

Xeljanz Lawsuits Can Be Very Complex to Prove

Winning a mass tort lawsuit for injuries caused by hazardous products or dangerous pharmaceuticals usually involves proving that the manufacturers did not properly warn people taking it of the potential risks. 

That can include investigating medical studies, corporate publications and using testimony from experts on how the medication caused an injury. This is not easily done, particularly when drug companies show up with an army of lawyers.

But battling bullies is what Justinian & Associates does best.

We Are Warriors For The Injured

Our Texas and San Antonio mass tort lawyers have successfully represented dozens of victims injured by unsafe medications and other hazardous products. 

That’s exactly why we were founded.

We have extensive knowledge of that area of law, along with the experience, the resources, experience and trained investigators to take on adversaries of any size.

All we do is fight for injured victims.

Our only goal is justice for our clients, whatever that means for them. And we do not accept defeat. Unless we get you money for your injuries, you don’t pay us a dime.

The Time to Act is Now

Your rights can be lost if you wait.

There are laws that limit how much time you have to file a lawsuit after being injured. They are known as statutes of limitation. They may apply to your lawsuit to recover for your Xeljanz injuries. The countdown may already have begun. 

The legal team at Justinian and Associates has years of experience dealing with cases like Philips CPAP and BiPAP breathing devices. 

The statute of limitations (how long you have to file a case) may already be counting down. Don’t let it expire!

Call, text or email us for a free consultation, with no obligation. 

Speak to a Texas personal injury attorney from Justinian & Associates (not a “screener” or paralegal) to understand your rights.

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^{[1] FDA In Brief: FDA responds to safety signal reported in required postmarketing trial for Xeljanz, Amanda Turney, FDA.gov Media Inquiries (February 25, 2019).}

^{[2] Xeljanz website.}

^{[3] Cytokines in Rheumatoid Arthritis (RA), Selim Nalbant and Ahmet Merih Birlik, New Developments in the Pathogenesis of Rheumatoid Arthritis (Feb. 22nd 2017).}

^{[4] The Janus kinases (Jaks), Yamaoka K, Saharinen P, Pesu M, Holt VE 3rd, Silvennoinen O, O’Shea JJ. Genome Biology (2004).}

^{[5] Xeljanz FDA Approval History, Drugs.com (updated by Judith Stewart, BPharm on Jan 28, 2021).}

^{[6] FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions, FDA.gov (9/01/2021).}