Written by: Laura Beasley, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
You may have read our previous articles about Xeljanz and its risk of leading to Pulmonary Embolism or even death. In June, we posted "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible" that provides information on the serious side effects found out through a post-marketing study on the drug. The FDA has finally put in place the “Black Box Warning" to draw attention to these serious risks.
Treatment and Trials
Xeljanz can be used to treat ulcerative colitis as well as psoriatic or rheumatoid arthritis. The recent article, “FDA Requires Box Warnings for Pfizer Drug Xeljanz”, relays information from the FDA that the 10 mg dosage twice a day should not be used for the aforementioned types of arthritis, just ulcerative colitis. Even further, it should only be used for ulcerative colitis if other medications are not sufficient for the patient.
The use of Xeljanz for the treatment of rheumatoid arthritis was discussed in the Milwaukee Journal Sentinel article, “FDA puts stringent warning on the Pfizer drug Xeljanz because of clots and deaths”, noting that:
The FDA also released data from a safety trial of the drug in people with rheumatoid arthritis, showing there were 19 blood clots in the lungs in those who got higher-dose Xeljanz compared with three who got other drugs known as TNF blockers. There also were 45 deaths in those who got high-dose Xeljanz compared with 25 who got TNF blockers.
The "Black Box Warning" came five months after this clinical trial. The FDA has received public criticism, such as from physician Michael Carome with Public Citizen, for "moving more slowly and less aggressively to protect public health relative to regulators in other countries"
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New Safety Precautions
Medscape also just published an article on the subject, “FDA Adds Boxed Warning on Risk for PE, Death With Higher Dose Tofacitinib (Xeljanz)”, which reports that in May, health officials in Europe had already advised physicians against the twice a day 10 mg dose of the medicine due to high risk of PE.
Edward V. Loftus, Jr., MD, the Chief Medical Editor of Healio Gastroenterology and Liver Disease, notes:
Based on what I have read, I do not know what the actual magnitude of that risk is, in other words, what’s the relative risk or absolute risk for thromboembolism?
But, there must have been some signal at the higher dose that they saw this signal and so, the European's put out the warning and now the FDA is basically putting out the same warning and they are making it a boxed warning.
While this is confusing, we just have to be cognizant of the warning, which is use the lowest dose possible that keeps your patient in remission.
As more information and developments arise regarding the safety of Xeljanz, we will make sure to provide updates whenever possible.