The Food and Drug Administration in the United States approves several new products to treat various diseases and illnesses each year after extensive testing. However, some of the products are still found to be highly toxic and cause harmful side effects.
People would then file lawsuits if the manufacturers of such toxic products are aware of their toxicity but deny this information to doctors and consumers.
If Pfizer’s Xeljanz is still being sued for side effects, it may be subject to multidistrict litigation. This blog clearly explains to you about Pfizer’s arthritis drug Xeljanz and how Xeljanz’s side effects lead Pfizer to the possibility of facing multiple lawsuits in the future and finally assists you in filing a claim if you are affected by Xeljanz.
Once going deeper into Pfizer’s Xeljanz lawsuits, let me first introduce you to medical record review, an essential element for your success in Xeljanz lawsuit that you will understand at the end of this blog.
Need Quality Medical Record Reviews?
Pfizer’s Xeljanz drug
What is Xeljanz? Pfizer’s Xeljanz(tofacitinib) and Xeljanz XR are medications approved by the Food and Drug Administration (FDA) to treat the following diseases:
- Rheumatoid arthritis– It is an autoimmune disease that is chronic, progressive, and disabling. In addition to affecting the joints and the areas around them, it may also affect other body regions.
- Ulcerative colitis– It is an inflammatory bowel disease that causes inflammation and ulcers in your digestive tract
- Ankylosing spondylitis– is a form of arthritis mainly affecting the spine, lower back, and sacroiliac joints.
- Psoriatic arthritis– It is a type of psoriatic disease. It is an inflammatory condition that involves pain and swelling in joints on one or both sides of the body and can also lead to fatigue.
Additionally, Xeljanz is approved for the treatment of polyarticular juvenile idiopathic arthritis, a disorder that causes joint inflammation in children under 16, by the FDA for children aged two and older.
Pfizer’s Xeljanz tofacitinib is available in these forms:
- Xeljanz as:
5-milligram (mg)
10-mg oral tablets
1 mg/milliliter oral solution
- Xeljanz XR as:
11-mg oral tablets
22-mg oral tablets
How Xeljanz works?
Pfizer’s Xeljanz acts by reducing the activity of Janus kinase enzymes, which are involved in the inflammation that results in diseases like rheumatoid arthritis and psoriatic arthritis.
Xeljanz is a long-term medication. Most patients who benefit from this medication will see improvements within the first twelve weeks of initiating the treatment.
History of Xeljanz
The large American pharmaceutical company Pfizer manufactured and delivered Xeljanz. The FDA approved Xeljanz’s use in the U.S. on November 6, 2012. Pfizer reported $1.7 billion in Xeljanz profits in 2018 and $51.8 billion in sales for 2019.
One of the most widely advertised and successful medications in history is Xeljanz. Sales of Xeljanz have brought in billions of dollars for Pfizer.
In truth, Pfizer reported that Xeljanz sales were $2.4 billion globally in 2020. Pfizer’s Xeljanz is a high-profit medicine that a pharmaceutical corporation wants to keep on the market at all costs.
Is Pfizer’s Xeljanz dangerous?
A large randomized safety clinical trial of the U.S. Food and Drug Administration concluded that there is an increased risk of severe problems with arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR.
In July 2019, the FDA ordered Pfizer to update the drug’s warning label to notify doctors and patients of the risks adequately.
Xeljanz side effects
When you stop taking Pfizer’s Xeljanz or Xeljanz XR, your symptoms may reappear. For instance, stopping your Xeljanz or Xeljanz XR therapy for rheumatoid arthritis (RA) could worsen your symptoms. Not everyone who stops using Xeljanz experiences this.
Consult your physician about the possibility of worsening symptoms if you want to stop taking Xeljanz or Xeljanz XR. To assist you in overcoming your symptoms, they will suggest alternative medicines.
Side effects of Pfizer’s Xeljanz
Some of the common side effects of Xeljanz drug are:
- High blood pressure
- Fatigue
- Sinus infections
- Upper respiratory tract infections
- Neutropenia
Some of the serious side effects of Pfizer’s Xeljanz and Xeljanz XR that led Pfizer to face multiple Xeljanz lawsuits are:
- Plasma problems
- Heart attack or stroke
- cancer risks
- immune system disorders
- Some people are at risk of death.
- Tears in the intestinal tract
- The danger of serious infections
- Blood clot
New Xeljanz warning
On July 26, 2019, the Food and Drug Administration granted new warnings about an increased risk with the 10 mg twice daily dose of Xeljanz and Xeljanz XR.
In September 2021, the FDA issued an updated medication safety warning for Xeljanz. According to the warning, Xeljanz at any dosage level increases the risk of major heart-related issues, including heart attacks and strokes, cancer, and blood clots, and sometimes leads a patient to death after receiving both doses of the medication.
On December 2, 2021, Xeljanz received the FDA’s most vital “black box” warning. According to the FDA’s newly updated warnings, to treat ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis, prescribers are highly suggested to use TNF blockers instead of Xeljanz.
Xeljanz deaths
Xeljanz (Tofacitinib), 10 mg twice daily, caused 19 pulmonary embolisms and 45 deaths in 3,884 patients, compared to 3 cases and 25 deaths in 3,982 patients with TNF blocker therapy.
When does Xeljanz go generic?
There are currently no generic versions of Xeljanz available in the United States. On the other hand, Sinotherapeutics, a specialty pharmaceutical company, intends to bring a generic version of Xeljanz XR to market before 2034 in the hope of circumventing the 181 patents.
Are there any Xeljanz lawsuits against Pfizer?
There aren’t many Xeljanz lawsuits against Pfizer because the warnings on the possibilities for Xeljanz tofacitinib side effects were only revealed recently. As of February 2022, there is no multidistrict litigation or Xeljanz class action lawsuit. But, as more individuals become conscious of Xeljanz’s adverse effects, this may change.
Also, attorneys are currently taking Xeljanz lawsuits from people with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis who took Xeljanz or Xeljanz XR and had blood clots in their lungs, thighs, or legs.
Pfizer arthritis drug lawsuit
Marilyn Stube, an Arkansas lady, filed a complaint against Pfizer in July 2019. She claimed that after using Pfizer’s Xeljanz for arthritis, she experienced the onset of infection in her body.
Her medical team treated her for rheumatic fever, multiple organ failure, gangrene, and a bacterial infection after taking the medication for four years. All four of her limbs were removed as a result of the disease.
According to the lawsuit against Xeljanz, Pfizer knew that Xeljanz had risks to patients but refused to warn them or their doctors. Pfizer is accused in the case of failing to follow its procedures, omitting information on sepsis from its clinical studies, and failing to tell the FDA of these issues.
Xeljanz Multidistrict Litigation
The first step in bringing a mass tort action against pharmaceutical companies is to gather and combine multiple cases in federal court, but the Xeljanz complaints have not yet gone through it. All of the lawsuits against Xeljanz are currently being heard in their respective courts.
Pfizer’s Bextra and Celebrex
Pfizer’s Xeljanz is not the first arthritis drug to face multiple lawsuits. Pfizer was previously acquitted in 2005 for its medicines -Bextra lawsuits and Celebrex lawsuits.
Approximately 1,200 plaintiffs sued Pfizer for personal injury or wrongful death and requested that Bextra and Celebrex be removed from the market because they increase the risk of heart attacks.
The court issued a final judgment in the Bextra litigation on September 25, 2009, and approved an $894 million settlement with Pfizer, settling claims that the company launched a false advertising campaign for its drugs Bextra and Celebrex.
Xeljanz update 2023
An important argument made by the plaintiffs in these claims is supported by research published in the New England Journal of Medicine on January 2023: Xeljanz is associated with a higher incidence of cancer and adverse cardiovascular events than other available treatments.
Xeljanz latest news
August 25, 2022 Update: For Pfizer’s Xeljanz, the bad news just continues to come in. An updated study published last week suggests that Xeljanz may have yet another dangerous side effect in addition to a higher risk of infection, which is already being linked to heart issues, blood clots, and cancer.
According to the research published in the Annals of Rheumatic Diseases, the infection risks associated with Xeljanz are double those of comparable medications.
March 2022 Update: The Xeljanz lawsuit plaintiffs’ case got more potent due to the medical literature. In a Mayo Clinic investigation, using Xeljanz and another Tumor Necrosis Factor (TNF) inhibitors were associated with higher rates of cancer incidence and unfavorable cardiovascular events (Remicade, Humira, Enbrel).
Possible claims against Pfizer’s Xeljanz
Pfizer is going to have to face claims from Xeljanz blood clot litigation for the following reasons:
- Pfizer negligently failed to conduct adequate safety research and testing before getting approval for Xeljanz.
- Pfizer knowingly hid this information despite being aware that the higher dose of Xeljanz caused blood clots and other issues.
- Pfizer neglected to mention the risk of blood clots and cardiovascular issues with higher Xeljanz doses.
Can you file a Xeljanz lawsuit?
Xeljanz lawsuits are in the preliminary stages. If you have been injured by taking the medication, a time limit called a statute of limitations, any law that bars claims after a certain period of time pass after an injury, determines how long you have to file a claim.
As the victim, you begin the proceedings by filing a Xeljanz lawsuit. An attorney can assist you in figuring out the timeline and launching your claim.
To file a claim against Pfizer for Xeljanz, you must meet three requirements:
- You should have used Xeljanz or Xeljanz XR for at least six months to treat your arthritis.
- You should have taken Xeljanz at a higher dosage of 10 mg twice daily.
- While on Xeljanz, you should have experienced a pulmonary embolism, deep vein thrombosis, stroke, or other blood clot-related issues.
You may bring a class action lawsuit against Xeljanz if you or your family members meet all three of these requirements.
Compensation for your Xeljanz lawsuits
Your compensation will depend upon the severity of the injury you experienced by Pfizer’s Xeljanz and how it caused you to suffer physical, financial, and emotional damages. You may be subjected to one or more of the following types of remuneration:
- Medical costs from the past and future to treat your injuries
- Your injuries’ physical and emotional pain and suffering from the past as well as the future.
- Loss of wages, if any
- Additional financial losses brought on by your injuries
- Punitive damages, as required.
It is absolutely essential to file a lawsuit against the manufacturer of the drug that is causing severe side effects for you or your loved ones, but battling a pharmaceutical company is not an easy process. You must ensure that your medical record is error-free.
LezDo TechMed assists attorneys in reviewing the medical records of plaintiffs. We are experts at extracting relevant data from medical records and presenting it as legal evidence.
This elevates your Xeljanz lawsuit, and you will be compensated more honestly as a result.
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Have there been any settlements?
As Pfizer’s Xeljanz litigation is recent and will likely take years to resolve, there are no large settlements involved to date.
Top arthritis drug lawsuits
Vioxx, manufactured by Merck, is a prescription drug used to treat the symptoms of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. US regulators approved the drug in 1999, and approximately 20 million Americans used it in a short time.
However, a colon-polyp prevention study published in 2004 found that it has the potential to double the risk of heart attack or stroke after 18 months of use.
As a result, the US Food and Drug Administration estimates that Vioxx caused between 88,000 and 139,000 heart attacks between 1999 and 2004. According to FDA experts, between 30% and 40% of these heart attacks were fatal.
Merck pulled its painkiller Vioxx from the market in late 2004. On January 15, 2016, Merck announced that it had agreed to pay $830 million to settle a federal class action lawsuit filed in New Jersey by plaintiffs who claimed that Merck had made misleading statements about the drug’s safety. This is considered as the largest lawsuit filed by any arthritis drug in the United States of America.
The Xeljanz lawsuits against Pfizer are in their initial phases. More information about this lawsuit will be released in the upcoming days. Our team has constantly been monitoring Xeljanz’s latest updates and will keep you updated through this blog.
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1/5 The FDA approved Pfizer’s Xeljanz to treat the following illness:
•Rheumatoid arthritis
•Ulcerative colitis
•Ankylosing spondylitis
•Psoriatic arthritis#newxeljanzwarning #isthereagenericformofxeljanz #pfizersxeljanzdrug #isxeljanzdangerous #howxeljanzworks pic.twitter.com/Bl3PzDQvlE— LezDo MedLegal (@LezDoMedLegal) October 12, 2022