October 2021 UK’s MHRA Xeljanz Action Follows September 2021 FDA Xeljanz Drug Safety Communication Update

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On September 1, 2021, we posted this article, “Xeljanz: FDA Warnings Updated: There are Higher Rates of Blood Clots and Deaths for Both Doses of Xeljanz, Now“, in which we listed the five Drug Injury Watch articles we wrote earlier in 2021 about Xeljanz drug safety developments. Now we are covering the latest drug regulatory action taken due to the Xeljanz risk of cardiovascular events as well as the Xeljanz risk of cancers, or malignancies, this one by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

This Drug Safety Update document, “Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies“, issued by the MHRA on October 6, 2021, states that Xeljanz should not be used by these patients in the groups identified below unless there is no suitable drug treatment alternative:

  • people older than 65 years of age;
  • people who are current or past smokers;
  • people with other cardiovascular risk factors, such as diabetes or coronary artery disease;
  • people with pre-existing cancer or malignancy risk factors.

As regards the Xeljanz side effects findings underlying these new Xeljanz use limitations, from the Safety Review part of this October 2021 MHRA Xeljanz document:

Study ORAL Surveillance (A3921133) was a large, randomised, active-controlled, clinical safety trial to evaluate the safety of tofacitinib versus tumour necrosis factor (TNF)-alpha inhibitors….

The co-primary endpoints of study A3921133 were adjudicated major adverse cardiac events and adjudicated malignancies (with the analysis excluding non-melanoma skin cancer)….

In 2021, final results from study A3921133 showed tofacitinib to be associated with an increased incidence of non-fatal myocardial infarction and malignancies, particularly lung cancer and lymphoma.

About the Xeljanz risk of cardiovascular events, we find this important information in the October 2021 MHRA Xeljanz document:

Predictive factors for development of myocardial infarction (fatal and non-fatal) were identified using a multivariate Cox model with backward selection. These factors were age older than 65 years, male sex, current or past smoking, history of diabetes, and history of coronary artery disease (which includes past myocardial infarction, coronary heart disease, stable angina pectoris, or past coronary artery procedures).

And about the Xeljanz risk of cancers, that document provides this information:

Predictive factors for development of malignancies (excluding non-melanoma skin cancer) were identified using a multivariate Cox model with backward selection. These were age older than 65 years and current or past smoking.

We will watch for possible additional drug regulatory actions due to the Xeljanz risk of cardiovascular events as well as the Xeljanz risk of cancers, and report significant developments here.

Our law firm is handling Xeljanz drug injury lawsuits for patients with cases of Xeljanz causing heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as Xeljanz causing lymphoma, lung cancer, and other cancers. Feel free to send me an email if we can be of assistance to you or someone you know.


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