New Health Warnings Issued For Xeljanz
The Food and Drug Administration (FDA) has issued new warnings for the arthritis-control medicines Xeljanz and Xeljanz XR. While the federal government’s investigation into these medications is ongoing, clinical evidence shows that Xeljanz may increase risk of heart-related problems. In some cases, Xeljanz may even cause death.1 If you or a loved one have used Xeljanz, you should speak with a healthcare professional to see if you have developed any of the health problems listed by the FDA. |
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.
If you or someone you know has been impacted by Xeljanz, contact Amber Pang Parra for a free consultation at (855) 452-5529 or pharma@justinian.com.
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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
- Carrera
- Cancer
- Blood clots
- Muerte
The F.D.A’s most recent warning suggests that people who take 10 mg of Xeljanz or Xeljanz XR twice per day are more likely to develop pulmonary embolisms.Pulmonary embolisms are a type of blood clot in the lungs that can be fatal. |
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
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
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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
- Fatiga
- Fiebre
- Sudores nocturnos
- Lingering cough
- Respiratory difficulties
- Pérdida de peso inexplicable
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:
- Facturas médicas
- Physical pain and suffering
- Psychological pain and suffering
- Lost wages or diminished earing capacity
- Muerte por negligencia
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.
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 o productos farmacéuticos peligrosos Por lo general, implica demostrar que los fabricantes no advirtieron adecuadamente a las personas que lo tomaron sobre los riesgos potenciales.
Eso puede incluir la investigación de estudios médicos, publicaciones corporativas y el uso de testimonios de expertos sobre cómo el medicamento causó una lesión. Esto no es fácil de hacer, especialmente cuando las compañías farmacéuticas se presentan con un ejército de abogados.
Pero luchar contra los matones es lo que mejor hace Justinian & Associates.
Somos guerreros para los heridos
Our Texas and San Antonio mass tort lawyers have successfully represented decenas de víctimas lesionadas por unsafe medications and other hazardous products.
Precisamente 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.
Todo lo que hacemos es luchar por las víctimas heridas.
Nuestro único objetivo es la justicia para nuestros clientes, sea lo que sea que eso signifique para ellos. Y no aceptamos la derrota. A menos que le consigamos dinero por sus lesiones, no nos paga ni un centavo.
El momento de actuar es ahora
Sus derechos pueden perderse si espera.
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.
El equipo legal de Justinian and Associates tiene años de experiencia en casos como los dispositivos respiratorios Philips CPAP y BiPAP.
Es posible que el estatuto de limitaciones (cuánto tiempo tiene para presentar un caso) ya esté en cuenta regresiva. ¡No dejes que caduque!
Llámenos, envíenos un mensaje de texto o envíenos un correo electrónico para una consulta gratuita, sin compromiso.
Speak to a Texas personal injury attorney from Justinian & Associates (not a “screener” or paralegal) to understand your rights.
[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).