Xeljanz Lawsuit – Heart & Lung Injuries

The Xeljanz lawsuit claims the use of Xeljanz can cause major cardiac events (including heart attacks and strokes), and blood clot complications (including pulmonary embolisms and deep vein thrombosis).

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What Do We Know About the Xeljanz Lawsuits?

Xeljanz Lawsuit

In 2019, the National Law Review reported on a surge of lawsuits caused by the use of the rheumatoid arthritis (RA) drug Xeljanz. This drug, which works by suppressing a patient’s immune system, resulted in some users suffering an heightened risk of pulmonary embolisms and deep vein thrombosis (DVT).

In February 2021, the Food and Drug Administration (FDA) reported on clinical trials showing Xeljanz was also associated with serious heart-related problems and cancer. According to the FDA, both the 5mg and 10mg doses of Xeljanz caused a higher risk of these injuries.

The Key Legal Issues Involving Xeljanz

The manufacturer of Xeljanz, Pfizer, designed a defective drug and failed to adequately warn healthcare professionals and patients about the risks of several potentially serious side effects.

In 2019, the FDA shared preliminary results from its study of Xeljanz highlighting data connecting the drug with blood clotting problems. Specifically, the agency reported 19 cases of blood clots in the lungs in patients who received Xeljanz 10 mg twice-daily compared to three cases in patients who received TNF blockers. The agency further reported 45 patient deaths among people who took 10 mg of Xeljanz twice-daily compared with 25 patient deaths for those who received TNF blockers.

As a result of these findings, the FDA required Pfizer to add a black box warning to its Xeljanz product labels, alerting patients and healthcare providers of the increased risk of blood clots and death with twice-daily doses of 10 mg each. These risks most affected rheumatoid arthritis patients who were at least 50 years old and demonstrated at least one cardiovascular risk factor. Pfizer did not warn about blood clot risks prior to the placement of this black box warning, which was ultimately added in July 2019.

In July 2019, Pfizer changed its Xeljanz labeling to include a boxed warning that describes a heightened risk of sudden cardiovascular-related death. The warning specified that rheumatoid arthritis patients who were 50 years and older experienced higher sudden cardiovascular deaths when they took 10mg of Xeljanz twice-daily.

On January 27, 2021, Pfizer issued a press release revealing trial data showing that Xeljanz failed to meet endpoint criteria for major adverse cardiovascular events (MACE). In a study of 4,362 subjects, 135 of the subjects experienced MACE, with the most frequent such event being myocardial infraction.

Pfizer also revealed that Xeljanz did not meet inferiority criteria for malignancies, with the exception of non-melanoma skin cancer. The study analysis showed that 164 of the 4,362 subjects who participated in the study suffered malignancies—the most frequently reported was lung cancer.

On February 4, 2021, the FDA issued a MedWatch Alert of the increased risk of serious heart-related problems and cancer. According to the FDA Adverse Event Reporting System (FAERS), 86,669 adverse events have been reported and tied to Xeljanz as of December 31, 2020. Of these events, 2,719 fall under the classification of cardiac disorders. In the same February 2021 FDA MedWatch Alert, the FDA revealed that 3,179 adverse events linked to Xeljanz fell in the class of “neoplasms benign, malignant, and unspecified.”

On September 1, 2021, the FDA required a revision to the black box warning for Xeljanz explaining the increased risk of serious heart-related events, cancer, blood clots, and death when using Xeljanz to treat certain chronic inflammatory conditions.


Xeljanz Injuries and Side Effects

The FDA has linked Xeljanz to cardiovascular events and venous thromboembolism.

Major Adverse Cardiovascular Events

Xeljanz has been linked to a greater rate of major adverse cardiovascular events, including:

  1. Cardiac arrest
  2. Cardiovascular death
  3. Congestive heart failure
  4. Coronary revascularization
  5. Myocardial infarction

Venous Thromboembolism

The adverse outcomes most associated with Xeljanz’s risk of blood clots include:

  1. Arterial thrombosis
  2. Cerebrovascular accident
  3. Deep vein thrombosis (DVT)
  4. Ischemic stroke
  5. Pulmonary embolism
  6. Pulmonary thrombosis
  7. Transient ischemic attack

Timeline of Events Pertinent to the Xeljanz Lawsuits

The following is the timeline for the Food and Drug Administration’s public communications regarding Xeljanz:

February 25, 2019: Risk of Blood Clots in Lungs and Death: This safety communication informed patients that a safety clinical trial of Xeljanz demonstrated a heightened risk of blood clots in the lungs. The risk applied to patients who took 10 mg twice-daily for treatment of rheumatoid arthritis (RA). This dose had been approved only for the treatment of ulcerative colitis, not for RA patients. Pfizer responded by transitioning its RA patients who were on the twice-daily 10 mg dose to a 5 mg dose twice-daily. Doctors were cautioned to monitor their patients for signs of pulmonary embolism.

July 26, 2019: Boxed Warning: The most significant message of this FDA communication was that the FDA had not only approved warnings regarding Xeljanz, but that the agency had also added its especially severe Boxed Warning. The warning conveyed the dangers of using the 10 mg twice-daily dose for RA and also stated that the risk of blood clots and death could also apply to patients taking Xeljanz for ulcerative colitis.

February 4, 2021: Serious Heart Problems and Cancer: The FDA issued a drug safety communication warning the public of the results from a safety clinical trial, which indicated a heightened risk of cancer and serious heart-related problems. The safety trial also explored other potential risks of taking Xeljanz, such as blood clots in the lungs, as well as death. 

September 1, 2021: Serious Heart-Related Events, Cancer, Blood Clots, and Death: “Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, [the FDA] concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib).”


What is the Purpose of Xeljanz?

Xeljanz Purpose

Xeljanz (tofacitinib) is used to treat rheumatoid arthritis and ulcerative colitis. The drug functions as a Janus kinase (JAK) inhibitor that blocks the immune’s system production of cytokine, a protein integral to the body’s inflammatory responses. By suppressing the immune system, swelling subsides, offering relief to the patient.

Xeljanz is a prescription drug that comes in two forms—as a tablet and as an extended-release tablet. The drug was first approved in 2012 as a treatment for adults with RA who had not responded well to methotrexate. It was then approved in 2017 to treat psoriatic arthritis in patients for whom methotrexate also failed to relieve joint pain and swelling. In 2018, the FDA approved the drug’s use in treating ulcerative colitis.


How Liability Law Applies to Xeljanz Cases

Under most state laws, a patient injured through the use of a defective drug can bring a lawsuit based on the following legal theories:

  1. Design Defect: When a drug is manufactured per design specifications, but the design itself renders the drug ineffective or unsafe;
  2. Manufacturing Defect: When a drug is safely designed, but has a defect through the manufacturing process, rendering it dangerous or unsafe; and/or
  3. Failure to Warn: When the drug manufacturer fails to warn the public of the risks or to provide adequate instructions about the use of the drug, thereby rendering it unsafe or dangerous.

All states enforce a statute of limitations that limits the amount of time you have to file a lawsuit against a drug manufacturer. A member of our legal team can inform you of your state’s laws.


Xeljanz Lawsuit News

‘We need to see the data’: FDA’s Xeljanz safety warning stirs concerns for JAK inhibitors

In this latest alert regarding Xeljanz, the FDA warned providers of an increased risk for serious heart-related issues and cancer among older patients, compared with TNF inhibitors. Reported in Healio News

FDA Weighs Tighter Restrictions for Pfizer’s Xeljanz on the Heels of Safety Red Flags

The FDA alerted patients and doctors that a postmarket study has linked Xeljanz to an increased risk of serious heart-related problems and cancer compared with TNF inhibitors, a group that includes such drugs as AbbVie’s Humira. The problems applied to both the 5-mg twice-daily dose and the higher 10-mg strength. Reported in Fierce Pharma

No Xeljanz Plan Yet From FDA

The FDA is “alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer” relative to tumor necrosis factor (TNF) inhibitors. Reported in MedPage Today

Pfizer Shares Co-Primary Endpoint Results from Post-Marketing Required Safety Study of XELJANZ® (tofacitinib) in Subjects with Rheumatoid Arthritis (RA)

For Xeljanz, the most frequently reported MACE was myocardial infarction and the most frequently reported malignancy (excluding NMSC) was lung cancer. In those subjects with a higher prevalence of known risk factors for MACE and malignancy (e.g., older age, smoking), a higher occurrence of events was seen across all treatment groups. Reported in BioSpace