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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

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

Stelara-associated Cardiovascular Events: Emerging Drug Safety Issue

October 29, 2020 By Law Offices of Thomas J. Lamb, P.A.

There is a new drug safety issue for Stelara. This time it is that Stelara-associated cardiovascular events were reported in a French medical study which, in turn, has resulted in some concern about the safety of Stelara. The Stelara French study results were outlined in this medical journal article, "Association Between Early Severe … [Read more...]

Filed Under: Unsafe Drugs Tagged With: Cardiovascular death, cardiovascular events, Stelara

Lemtrada Side Effects Being Investigated By European Drug Regulatory Agency

April 29, 2019 By Law Offices of Thomas J. Lamb, P.A.

The multiple sclerosis drug Lemtrada (alemtuzumab) is under scrutiny from the European Medicines Agency (EMA), according to the drug regulator’s April 12, 2019 press release, “Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing”. From this April 14, 2019 Medscape article, “PRAC Restricts Use of Alemtuzumab for MS … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cardiovascular events, Lemtrada, liver damage, pulmonary side effects

Zelnorm: FDA Approval In 2019 (After 2007 Recall) Despite Continuing Cardiovascular Safety Concerns

April 29, 2019 By Law Offices of Thomas J. Lamb, P.A.

In April 2019 we learned that the FDA is allowing Zelnorm back on the market 12 years after there was an FDA-mandated Zelnorm recall. From this April 3, 2019 Healio article, “FDA approves reintroduction of Zelnorm for IBS-C in certain women”, we get this significant point: Sloan Pharmaceuticals [(the responsible drug company)], a subsidiary of … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cardiovascular events, Heart Attacks, Myocardial Infarctions (MI), Strokes, Zelnorm

February 2019: Uloric “Black-Box Warning” For Heart-Related Deaths, Cardiovascular Side Effects

March 5, 2019 By Law Offices of Thomas J. Lamb, P.A.

The FDA has required its strongest safety warning, i.e., Bolded Warning or Black-Box Warning, be included on a new Uloric drug label to inform about the increased risk of heart-related death and death from all causes with Uloric. From this February 2019 FDA Drug Safety Communication, "FDA adds Boxed Warning for increased risk of death with gout … [Read more...]

Filed Under: Unsafe Drugs Tagged With: cardiovascular events, Heart Attacks, heart-related deaths, Myocardial Infarctions (MI), nonfatal myocardial infarctions, Strokes, Uloric

Xeljanz Used For Ulcerative Colitis May Increase Risk Of Pulmonary Embolism

February 26, 2019 By Law Offices of Thomas J. Lamb, P.A.

There appears to be a new Xeljanz drug-safety problem for patients with ulcerative colitis (UC) who use the 10 mg twice daily recommended dosage of Xeljanz. In a February 20, 2019 Endpoints News article written by John Carroll, “Pfizer drops 10 mg dose of best-selling Xeljanz as study spotlights cardio safety issue, higher rate of deaths”: One … [Read more...]

Filed Under: Unsafe Drugs Tagged With: Cardiovascular death, cardiovascular events, Pulmonary Embolism (PE), Xeljanz

Uloric Recall Discussed By FDA Advisory Committees In January 2019

January 25, 2019 By Law Offices of Thomas J. Lamb, P.A.

On January 10, 2019 the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee panelists discussed the potential biological mechanisms behind cardiovascular (CV) events associated with Uloric (febuxostat) use. From this January 11, 2019 MedPage Today report, “Make Uloric Second-Line for Gout, FDA Advisors Say”, … [Read more...]

Filed Under: Unsafe Drugs Tagged With: Cardiovascular death, cardiovascular events, Uloric

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