New York Xeljanz Attorneys
Pfizer’s popular rheumatoid arthritis drug Xeljanz has failed an FDA safety study, leaving in peril the drug’s future and further tarnishing a pharmaceutical giant. The drug failed the required FDA safety test after the governmental agency had suspicions about the drug’s safety and efficacy.
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FDA Issues Safety Alert for Xeljanz
The FDA has issued a safety alert warning patients and health providers of an increased risk for serious health-related problems and cancer linked to tofacitinib compared with TNF inhibitors among older patients. As part of the alert, the FDA has recommended that health care professionals consider the benefits and risks associated with tofacitinib (Xeljanz, Pfizer) when making treatment decisions for patients with rheumatoid arthritis or ulcerative colitis. Physicians should continue to follow the recommendations included in the drug’s prescribing information.
The alert is based on preliminary results from ORAL Surveillance, a post-marketing safety clinical trial required by the FDA to demonstrate non-inferiority of Xeljanz compared to TNF inhibitors among patients with RA with regard to risk for cardiovascular events and malignancies. This trial also investigated other potential risks, including blood clots in the lungs and death.
The failed safety study is more bad news for a once promising drug. In 2019, Pfizer was required to put a “black box” warning on all labels of Xeljanz. Such a black box warning is normally the death knell for a drug or medical device. Today’s news only highlights the earlier warning and adds emphasis to it. The company received two separate warnings in 2019, one in February and the other in July, that there is an increased risk of blood clots and death with the higher 10 mg twice daily dosage, and as a result, approved a Boxed Warning to the tofacitinib prescribing information. These 2019 warnings are confirmed by this failed safety study.
The FDA safety study showed that Xeljanz (tofacitinib), used to treat rheumatoid arthritis and ulcerative colitis, is linked with a higher rate of heart attacks and cancer than a TNF inhibitor in patients aged over 50 with underlying cardiovascular risk factors.
With more than 4,300 subjects recruited, the ORAL Surveillance trial has turned into a costly gamble by Pfizer on its flagship immunology brand, which brought in sales of more than $1.7 billion in the first nine months of 2020.
The warning concerning the failed safety test may be read in its entirety here. This is the most relevant excerpt:
“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 with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.”
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