Pfizer Inc. Allegedly Hid Risks of Sepsis & Amputation on Xeljanz Labels; FDA Approves “Black Box” Warnings for the Drug

A recent lawsuit alleges that Pfizer Inc., the manufacturer of widely used arthritis drug Xeljanz, failed to warn U.S. customers that the drug can cause sepsis leading to amputation. After reviewing initial findings from recent clinical trials of the drug, the Food and Drug Administration (FDA) has approved the use of “black box” warnings on the packaging of Xeljanz and XR highlighting the risks associated with the drug. Here, the product liability attorneys at Sullivan Papain Block McManus Coffinas & Cannavo, P.C. discuss the recent FDA updates and allegations surrounding Xeljanz.

Lawsuit Resulted from Plaintiff’s Sepsis and Amputation  

An Arkansas woman recently filed a lawsuit against drug manufacturer, Pfizer Inc., claiming that the arthritis drug, Xeljanz, caused her to develop sepsis. The condition ultimately resulted in the removal of all four of her limbs. The plaintiff, Marilyn Stube, claimed that after taking Xeljanz for four years, she began to experience fever, nausea and pain. She was later diagnosed with septic shock, multi-organ failure, gangrene and Group A Streptococcus, which required the amputation of her arms and legs. Specifically, the suit claims that women, the elderly and those with pre-existing conditions, such as shingles, are at an increased risk of infection when taking Xeljanz for extended periods. The claim indicates that Pfizer allegedly knew these risks and failed to warn the public. 

Labels in European Union and Other Countries Warn Consumers of Risks

While labeling for Xeljanz sold in the United States does not indicate the risk of sepsis and other serious side effects, packaging for Xeljanz sold in the European Union, Australia, Canada and other countries does contain those warnings. In fact, Pfizer’s initial application to approve the sale of Xeljanz in the European Union was rejected in part due to the concerns of sepsis. An arthritis drug previously manufactured by Pfizer, called Enbrel, also contained a warning for sepsis on U.S. and other countries’ labels. 

Lawsuit Details Alleged Deception by Pfizer in Labelling and Reporting

Pfizer’s standard operating procedure for cross-country labels is to maintain consistency in content. However, the recent lawsuit alleges that Pfizer forewent this procedure in order to broaden the potential consumer base for the product in the United States. Beyond this claim, the suit alleges that Pfizer failed to report adverse events related to Xeljanz to the U.S. Food and Drug Administration and excluded data from clinical trials to improve their results. 

FDA Updates Warnings on Packaging of Xeljanz and Xeljanz XR to Highest Level “Black Box” Warning

Recently, the FDA approved the highest level “black box” warning to be included on the packaging of Xeljanz and Xeljanz XR that will highlight an increased risk of blood clots and of death with the 10 mg twice daily dose of the drug. This warning comes after the FDA’s review of preliminary results from ongoing safety clinical trials in patients with rheumatoid arthritis. According to the FDA, “The 10 mg twice daily dose of tofacitinib is not approved for RA or psoriatic arthritis (PsA). This dose is only approved for ulcerative colitis for initial treatment and for long-term use in limited situations.”

Seek the Support of Sullivan Papain Block McManus Coffinas & Cannavo, P.C. Today 

Deceptive marketing and labeling of medication is a practice that can have dangerous and life-altering consequences for the individuals who rely on these drugs. It is critical that drug manufacturers and distributors be held accountable for the deceptive marketing practices that put patients at risk. If you or a loved one has been prescribed Xeljanz and experienced symptoms such as nausea, fever or pain, you are strongly urged to speak with a physician. You may also be entitled to compensation for your suffering. To learn more about how the product liability attorneys at Sullivan Papain Block McManus Coffinas & Cannavo, P.C. can help, contact our New York or New Jersey law offices today.