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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 even lethal unfortunately. 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 corporate profit. However, in just the last two years, the U.S. Food and Drug Administration (FDA) has warned that Xeljanz can be associated with heart problems, blood clots, and even cancer. But the question remains: why did not Pfizer warn consumers about these potential risks sooner? Xeljanz lawsuits claim that Pfizer failed to give adequate warning about the Xeljanz'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. If you experienced Xeljanz's side effects, call a Xeljanz lawyer today.  Contact Xeljanz Lawyer Timothy L. Miles today. About XeljanzXeljanz 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:
Xeljanz has been approved for several different uses:
Post-Marketing Xeljanz Study Reveals Serious Safety ConcernsMost Americans assume that if a drug is approved by the FDA, it has been thoroughly evaluated for safety and efficacy. However, this is not 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. Here, the Xeljanz study revealed serious safety concerns. When the FDA first approved Xeljanz in 2012, it ordered a post-marketing Xeljanz safety study known as ORAL Surveillance. But rather than confirming the safety of Xeljanz, the post-marketing Xeljanz Study Revealed Serious Safety Concerns and has led to new health alerts and warnings. Post-Marketing Xeljanz Study Reveals Serious Safety ConcernsMost Americans assume that if a drug is approved by the FDA, it has been thoroughly evaluated for safety and efficacy. However, this is not 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. Here, the Xeljanz study revealed serious safety concerns. When the FDA first approved Xeljanz in 2012, it ordered a post-marketing Xeljanz safety study known as ORAL Surveillance. But rather than confirming the safety of Xeljanz, the post-marketing Xeljanz Study Revealed Serious Safety Concerns and has led to new health alerts and warnings. Some Patients took Xeljanz and Developed Blood ClotsIn February 2019, the FDA warned that the ongoing Xeljanz safety trial found an increased risk of taking Xeljanz and developing 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:
Xeljanz and CancerThe 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):
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:
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 a Xeljanz Lawyer TodayIf you took Xeljanz as prescribed and developed a malignancy, thrombosis, or heart-related issues, contact Xeljanz Lawyer Timothy L. Miles today. Timothy L. Miles, Esq.Timothy L. Miles is a nationally recognized shareholder rights attorney raised in Nashville, Tennessee. Mr. Miles was recentely selected by Martindale-Hubbell® and ALM as a 2022 Top Ranked Lawyer, 2022 Top Rated Litigator. and a 2022 Elite Lawyer of the South. Mr. Miles also maintains the AV Preeminent Rating by Martindale-Hubbell®, their highest rating for both legal ability and ethics. Mr. Miles is a member of the prestigious Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a superb rated attorney by Avvo, a recipient of the Lifetime Achievement Award by Premier Lawyers of America (2019) and recognized as a Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019). Mr. Miles has published over sixty articles on various issues of the law, including class actions, whistleblower cases, products liability, and more. Comments are closed.
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