What should you do when a medication makes you feel worse, not better? Whether it’s over-the-counter medicine or a prescription from a doctor, drugs are meant to treat a patient. However, when the side effects exceed the benefits, medicines can become very dangerous and sometimes lethal.
Pharmaceutical companies and suppliers have both an ethical and legal responsibility to properly disclose the risks and side effects of a drug before bringing it to market, but all too often those warnings are withheld in the name of profit.
Pfizer’s Xeljanz (tofacitinib) has been on the market since 2012. First approved to treat rheumatoid arthritis, Xeljanz has since received FDA approval for the treatment of other types of arthritis as well as ulcerative colitis.
In just the last two years, however, the FDA has warned that Xeljanz can be associated with heart problems, blood clots, and even cancer. But the question remains: why didn’t Pfizer warn consumers about these potential risks sooner?
Xeljanz lawsuits claim that Pfizer failed to give adequate warning about the drug’s side effects, which caused preventable harm to patients who suffered blood clots in the lungs, heart attacks, strokes, breast and colon cancer, and other severe health problems. Morgan & Morgan’s dangerous drug lawyers are accepting these cases on a contingency-fee basis. That means our clients don’t pay unless we win. If you need to discuss a lawsuit with our Xeljanz lawyers, free of charge, please contact us.
Xeljanz belongs to a class of drugs known as Janus kinase (JAK) inhibitors. As Pfizer explains, our body has signaling proteins called cytokines that regulate immune system responses. The production of cytokines is increased when our body fights infection. Cytokine production is thought to play a role in chronic inflammatory conditions, such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Xeljanz disrupts signaling that produces some of the cytokines, reducing inflammation. Specifically, Xeljanz blocks—or inhibits—the release of cytokines in the JAK signal pathway.
Xeljanz has been approved for several different uses:
- 2012: FDA approves Xeljanz for rheumatoid arthritis
- 2017: FDA approves Xeljanz and Xeljanz XR (extended release) for psoriatic arthritis
- 2018: FDA approves Xeljanz for ulcerative colitis
- 2020: FDA approves Xeljanz for polyarticular juvenile idiopathic arthritis
Post-Marketing Xeljanz Study Reveals Serious Safety Concerns
Most Americans assume that if a drug is approved by the FDA, it has been thoroughly evaluated for safety and efficacy. However, this isn’t always the case. In addition to pre-approval clinical testing, the FDA may order post-marketing studies as a condition of drug approval. These trials gather more information about a drug’s safety, efficacy, or optimal use.
When the FDA first approved Xeljanz in 2012, it ordered a post-marketing safety study known as ORAL Surveillance. But rather than confirming the safety of Xeljanz, this study has led to new health alerts and warnings.
Xeljanz and Blood Clots
In February 2019, the FDA warned that the ongoing Xeljanz safety trial found an increased risk of blood clots in the lungs and death. In July 2019, the FDA announced that it had approved new warnings about thrombosis and death in patients treated with a 10 mg twice-daily dose of Xeljanz.
Thrombosis occurs when a blood clot blocks a vein or artery. Deep vein thrombosis, pulmonary embolism, and arterial thrombosis have all been reported in Xeljanz patients.
- A blood clot in a deep vein is known as a deep vein thrombosis (DVT). DVT usually occurs in the legs.
- A blood clot that travels to the lungs is called a pulmonary embolism (PE). PE is usually caused by a blood clot that starts in the arm or the leg.
- Arterial thrombosis is a blood clot in an artery. This type of thrombosis can stop blood from reaching vital organs.
Blood clots can lead to a heart attack, stroke, organ damage, and even death. Symptoms of a blood clot include:
- Sudden shortness of breath
- Chest pain that gets worse with breathing
- Swelling of the arms or legs
- Leg pain or tenderness
- Red or discolored skin in the painful or swollen leg or arm
Xeljanz and Cancer
The next major safety news to come out of the Xeljanz post-marketing study was equally concerning. The FDA alerted the public in February 2021 that preliminary results showed an increased risk of cancer with Xeljanz.
Pfizer reports in a press release that malignancies observed in Xeljanz studies include (but are not limited to):
- Lung cancer
- Breast cancer
- Prostate cancer
- Pancreatic cancer
Xeljanz and Cardiovascular Problems
Also in February 2021, the FDA warned about serious heart-related problems that may result from Xeljanz use. Pfizer refers to these in its press release as “major adverse cardiovascular events” (MACE).
Pfizer reports that a total of 135 patients in the study had a major adverse cardiovascular event, although the full results have not yet been released. The most frequently reported event was myocardial infarction (i.e. heart attack).
- Other cardiac events that may be linked to Xeljanz include:
- Cardiac arrest
- Cardiovascular death
- Ischemic stroke
- Acute coronary syndrome
- Heart failure
- Atrial fibrillation
Contingency-Fee Xeljanz Lawyers
Taking on a big pharmaceutical company requires a big law firm to support you. Morgan & Morgan has the resources, strength, and skill to successfully challenge big drug companies like Pfizer in court. And we handle every case on a contingency-fee basis, so our clients don’t pay a dime unless we recover money for them.
We are currently speaking to clients across the country about Xeljanz cancer, blood clot, and cardiovascular lawsuits. Patients who took Xeljanz as prescribed and developed a malignancy, thrombosis, or heart-related issues may qualify for a lawsuit. Lawsuits against Pfizer can recover compensation for medical bills, lost wages, pain and suffering, reduced quality of life, and more.
Call or contact us today to speak with a Xeljanz lawyer during a no-cost, no-obligation case review.