On September 1, 2021, we saw new FDA Xeljanz warnings about the increased risks of heart attacks, strokes, cancer, blood clots, and deaths. These Xeljanz drug safety problems have been associated with all doses of Xeljanz (5 mg tablet and 10 mg tablet) and Xeljanz XR (11 mg tablet and 22 mg tablet).
This September 2021 document, “FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions“, begins with the following new information:
Based on a completed U.S. Food and Drug Administration (FDA) review of a large randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior DSC based upon earlier results from this trial, reported an increased risk of blood clots and death only seen at the higher dose.
In more detail, from the Data Summary section of the above-referenced September 2021 document, here are the most recent FDA findings as regards various Xeljanz side effects:
There was an increased risk of death, MACE, malignancies, and thrombosis associated with both regimens of Xeljanz. The data showed evidence of a dose-dependent increased risk for [major adverse cardiovascular events (MACE) — defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke], all-cause mortality, and thrombosis at both doses of Xeljanz when compared to treatment with [tumor necrosis factor (TNF) blockers]. Additionally, the data showed evidence of a non-dose-dependent increased risk for malignancy excluding [nonmelanoma skin cancer (NMSC)] at both doses of Xeljanz when compared to TNF blockers. Lymphomas and lung cancers were observed at a higher rate in patients treated at both doses of Xeljanz compared to those treated with TNF blockers. In particular, a higher rate of lung cancers was observed in current or past smokers treated with Xeljanz. Current or past smokers had an additional increased risk of overall cancers.
We will continue to monitor the Xeljanz drug safety problems of serious side effects and adverse drug reactions suffered by some patients who were using Xeljanz as prescribed by their doctor.
Further, we expect these new FDA Xeljanz warnings in September will lead to the filing of more Xeljanz lawsuits against Pfizer for cases of Xeljanz causing heart problems such as heart attacks and strokes as well as Xeljanz causing cancers.
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