Lymphoma Archives | Law Offices Of Thomas J. Lamb

This excerpt from the “Advisory – Health Canada safety review finds link between the use of Xeljanz and Xeljanz XR (tofacitinib) and increased risk of serious heart-related issues and cancer” issued in January 2022 provides an overview of the Xeljanz drug safety issue, and how the Xeljanz side effects risks may also apply to Olumiant and Rinvoq:

Health Canada completed a safety review that confirmed a link between the use of Xeljanz/Xeljanz XR and the increased risks of serious heart-related problems and cancer, especially in older patients, patients who are current or past smokers, and patients with cardiovascular or cancer risk factors. Health Canada’s review also found that all patients treated with Xeljanz 10 mg twice daily had a higher risk of death, blood clots and serious infections, compared to patients treated with Xeljanz 5 mg twice daily or tumour necrosis factor inhibitors (TNFi)….

Health Canada has also initiated a new safety review of the potential risks of serious heart-related problems, cancer and blood clots with two other drugs of the same class as Xeljanz/Xeljanz XR (i.e. Olumiant and Rinvoq) that work similarly for the treatment of similar diseases.

The Health Canada Xeljanz Advisory gives some more detailed information in a section intended for healthcare professionals but, no doubt, of interest to patients using Xeljanz — as well as Olumiant or Rinvoq, perhaps:

Inform patients that Xeljanz/Xeljanz XR may increase their risk of major adverse cardiovascular events including non-fatal myocardial infarction. Instruct all patients, especially geriatric patients, current or past smokers, or patients with other cardiovascular risk factors, to be alert for signs and symptoms of cardiovascular events.
Inform patients that Xeljanz/Xeljanz XR may increase their risk of certain cancers, and that lung cancer, lymphoma and other cancers have been observed in patients taking Xeljanz. Instruct patients to inform their healthcare provider if they have ever had any type of cancer.

Our law firm is investigating possible drug injury lawsuits for patients who used Xeljanz, Olumiant, or Rinvoq and then suffered one of the serious side effects associated with these JAK inhibitors drugs. In particular, 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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Olumiant (baricitinib), Xeljanz (tofacitinib), and Rinvoq (upadacitinib) are the three 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, Xeljanz, and Rinvoq 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, Rinvoq, or Xeljanz 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]

Xeljanz | Rinvoq | Olumiant

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Xeljanz Safety Alert for People Who Are (1) Older, (2) Current / Past Smokers, or (3) With Cardiovascular or Cancer Risk Factors

Xeljanz | Rinvoq | Olumiant

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Olumiant and Those JAK Inhibitors Drug Safety Issues: Eli Lilly’s “Spin”

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