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Xeljanz, Rinvoq, and Olumiant Safety Review by European Drug Regulator EMA

February 16, 2022 By Law Offices of Thomas J. Lamb, P.A.

The JAK inhibitors drug class safety issue has landed in Europe, as indicated by this European Medicines Agency (EMA) February 11, 2022, news item, “EMA starts safety review of Janus kinase inhibitors for inflammatory disorders”. This Xeljanz, Rinvoq, and Olumiant safety review by the EMA follows a December 2021 JAK inhibitors drug class safety FDA … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cancers, cardiovascular deaths, cardiovascular events, Heart Attacks, Olumiant, Rinvoq, Strokes, Xeljanz

Xeljanz Safety Study Final Findings Presented in January 2022

February 4, 2022 By Law Offices of Thomas J. Lamb, P.A.

The Xeljanz safety study final findings from the so-called “ORAL Surveillance” trial ordered by the FDA were examined in this January 26, 2022 article, “Trial Data Confirm Heightened Risks With JAK Inhibitor”, by medical news reporter John Gever for MedPage Today. That January 2022 MedPage Today news report provides a “snapshot” of the current … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cancers, cardiovascular events, Olumiant, Rinvoq, Xeljanz

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

January 21, 2022 By Law Offices of Thomas J. Lamb, P.A.

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 … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cancers, cardiovascular events, heart problems, lung cancer, lymphoma, Myocardial Infarction, Olumiant, Rinvoq, Xeljanz

Cancers, Blood Clots, Heart Problems, and Deaths Associated with Xeljanz, Olumiant, and Rinvoq

December 15, 2021 By Law Offices of Thomas J. Lamb, P.A.

We continue to monitor the pharmaceutical regulatory sector as well as the medical literature for developments as regards the increased risks of cancers, blood clots, heart problems, and deaths associated with Xeljanz, Olumiant, and Rinvoq. In December 2021 there was another JAK inhibitors drug class safety development, with Xeljanz, Olumiant, … [Read more...]

Filed Under: Unsafe Drugs Tagged With: blood clots, cancers, heart problems, Olumiant, Rinvoq, Xeljanz

Olumiant or Xeljanz: Is One of These JAK Inhibitor Drugs Safer?

December 2, 2021 By Law Offices of Thomas J. Lamb, P.A.

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 … [Read more...]

Filed Under: Unsafe Drugs Tagged With: JAK inhibitors, Olumiant, Rinvoq, Xeljanz

Drug Regulator MHRA Imposes More Xeljanz Use Limitations in October 2021

October 14, 2021 By Law Offices of Thomas J. Lamb, P.A.

In this Drug Safety Update document, “Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies”, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) took new regulatory action regarding the Xeljanz risk of cardiovascular events as well as the Xeljanz risk of cancers, or … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cancer, cardiovascular events, Xeljanz

Possible New Xeljanz Side Effect: Peripheral Neuropathy

October 1, 2021 By Law Offices of Thomas J. Lamb, P.A.

As reported in this Letters to the Editor item, “Tofacitinib and Risk of Peripheral Neuropathy? Experience of 2 Cases in Patients With Rheumatoid Arthritis”, patients treated with Xeljanz (tofacitinib) for their rheumatoid arthritis (RA) may be at risk of neurological adverse events, such as Xeljanz-related peripheral neuropathy. That item about … [Read more...]

Filed Under: Unsafe Drugs Tagged With: Peripheral Neuropathy, Xeljanz

Xeljanz: Heart Attacks, Strokes, Cancers, Blood Clots, and Deaths – Updated FDA Warnings 2021

September 7, 2021 By Law Offices of Thomas J. Lamb, P.A.

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 … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cancer, Heart Attacks, heart problems, Strokes, Xeljanz

FDA Advisory Committee Meeting Could Review Risk/Benefit Profiles for All JAK Inhibitors

July 8, 2021 By Law Offices of Thomas J. Lamb, P.A.

The FDA has delayed its decision for Abbvie’s applications to have Rinvoq approved for the additional indications of psoriatic arthritis and ankylosing spondylitis, apparently due to possible new JAK inhibitors heart side effects and cancer risks issues identified in connection with a Xeljanz safety signal. From this June 25, … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cancer, Heart Attacks, Rinvoq, Strokes, Xeljanz

Possible FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in Future

April 20, 2021 By Law Offices of Thomas J. Lamb, P.A.

Based on these several recent developments, we expect that there will be an FDA Advisory Committee Meeting for Xeljanz, Olumiant, and Rinvoq in the months to come. The focus of such will likely be these adverse drug events and side effects related to the JAK inhibitors class of drugs: Heart AttacksMyocardial Infarction (MI)Strokes — Ischemic / … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cancer, heart problems, Olumiant, Rinvoq, Xeljanz

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