Olumiant (baricitinib) and Xeljanz (tofacitinib) are the two Janus kinase (JAK) inhibitors currently approved by the FDA for the treatment of arthritis and other inflammatory conditions. In September 2021 the FDA announced a JAK inhibitors drug class label change. Specifically, the FDA is requiring revisions to the “Black-Box” warnings for Olumiant and Xeljanz, as well as Rinvoq (upadacitinib), to include information about the increased risk of serious side effects associated with JAK inhibitors drugs.
Olumiant is an Eli Lilly drug, and this pharmaceutical company is attempting to distinguish the safety profile of their respective JAK inhibitors drug product from the JAK inhibitors drug class safety issues flagged by the FDA.
For example, there is this Lilly News Release document, “OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis”, which was issued on November 9, 2021.
For some analysis and context about that November 2021 Olumiant press release from Eli Lilly, we refer you to this Fierce Pharma news report, “Eli Lilly touts long-term safety data for Olumiant amid classwide scrutiny on JAK meds”, published on November 10, 2021.
In the new pooled analysis, the incidence of major adverse cardiovascular events (MACE) for Olumiant was 0.51 per 100 patient-years of exposure, which Lilly said falls within the range in the general rheumatoid arthritis population as described in epidemiological studies….
In a subgroup of patients over 50 years old who had at least one existing heart risk factor, the incidence rate of MACE [for Olumiant] was higher at 0.77 per 100 patient-years.
That latter patient population was targeted in Pfizer’s postmarketing safety study for Xeljanz. As [Pfizer] disclosed earlier this year, Xeljanz’s MACE incidence rate was 0.91 per 100 person-years at the 5 mg dose….
As for the cancer rates, the age-adjusted number for Olumiant was 0.92 per 100 person-years, which Lilly again said appeared similar to the general U.S. population. In the Pfizer trial, Xeljanz recorded a cancer rate of 1.13….
The FDA is still considering the details of the JAK inhibitors drug class “Black-Box” warnings label change it announced in September 2021.
Our law firm is investigating possible drug injury lawsuits for patients who used Olumiant, Xeljanz, or Rinvoq and then suffered serious side effects associated with JAK inhibitors drugs. These include heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as cancers such as lymphoma and lung cancer.[Read article in full at original source]
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