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Janus Kinase Inhibitor Lawsuit Lawyers Report that the FDA Has Linked Cancer, Heart Attacks, Lung Blood Clots, and Death to Certain Janus Kinase Inhibitors According to a news report on dermatologytimes.com, the U.S. Food and Drug Administration is mandating a new black box warning on Janus Kinase Inhibitors (JAK). After the FDA conducted a safety review […]
Janus Kinase Inhibitors
According to a news report on dermatologytimes.com, the U.S. Food and Drug Administration is mandating a new black box warning on Janus Kinase Inhibitors (JAK). After the FDA conducted a safety review of Janus Kinase Inhibitors, the FDA published a new drug safety announcement that states that Janus Kinase Inhibitors have been linked with an “excess risk” of developing cancer, severe heart-related issues, blood clots in the lungs, and death. The FDA has ordered additional black box warning labels on Janus Kinase Inhibitors.
A separate FDA warning concerning Janus Kinase Inhibitors was published back in February. That drug safety announcement by the FDA reported the risk for severe health-related complications and cancer associated with tofacitinib (Xeljanz, Pfizer) as compared to TNF inhibitors taken by older patients. However, after receiving the new safety information, the FDA issued new and updated warnings concerning two other JAK inhibitors: upadacitinib (Rinvoq, AbbVie) and baricitinib (Olumiant, Eli Lilly & Co.).
The FDA’s safety review of Janus Kinase Inhibitors found that this Class of medications is connected with an excess risk for blood clots, cancer, serious heart-related events, and death. FDA officials stated that the agency is requiring changes to the JAK Boxed Warnings, which is the FDA’s most notable warning, for Olumiant, Rinvoq, and Xeljanz/Xeljanz XR, to list the increased risks of cancer, blood clots, serious heart-related events, and death.
According to the news report, the FDA has not studied other JAK inhibitors in comparable large-scale clinical trials. This means the risks associated with those medications have not been evaluated. But, these medications share the same mechanisms of action as Xeljanz, and the FDA deems these medicines to have similar risks as observed in the safety trial conducted on Xeljanz.
The FDA based its new black box warning on results analyzed from ORAL Surveillance, which is a post-marketing clinic trial required by the FDA to prove the non-inferiority of Xeljanz as compared to TNF inhibitors amongst patients suffering from rheumatoid arthritis with respect to risk for malignancies and cardiovascular events. This clinical safety trial also examined other possible health risks, such as blood clots in the lungs and death.
The updated JAK inhibitors warning labels will address the heightened risk of severe adverse cardiovascular events, thrombosis, malignancy, and death. Moreover, the FDA is urging health care professionals to weigh the benefits and risks for each particular patient before starting or continuing therapy with JAK inhibitors, especially amongst patients who are past or current smokers, patients who develop a malignancy, patients with other cardiovascular risk factors, and patients with known malignancies other than nonmelanoma skin cancer that has been successfully treated.
Were you or a loved one harmed by JAK inhibitors? Parker Waichman LLP helps families recover monetary compensation for harm caused by defective medications. For your free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).