Blood Clot Concerns Prompt EU Restrictions For Pfizer's Xeljanz

 
• By Vibha Sharma
  
Generate a summary of this article
Listen to this article
Beta

The European Medicines Agency's pharmacovigilance committee has launched a fresh review of Xeljanz and has also recommended suspending all fenspiride medicines, which are used to treat non-serious cough but are associated with heart rhythm problems.

SideEffects
The EMA Is Re-Examining The Safety Of Xeljanz • Source: Shutterstock

The European Medicines Agency's pharmacovigilance committee, the PRAC, has recommended temporarily restricting the use of Pfizer Inc.'s drug Xeljanz (tofacitinib) in some high-risk patients due to concerns of increased risk of blood clots in the lungs and death. Also, it has recommended that cough medicines containing fenspiride should no longer be marketed as they are associated with heart rhythm problems.

Xeljanz is currently authorized for the treatment of rheumatoid arthritis, psoriatic arthritis and severe ulcerative colitis.

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Europe

EU Biosimilar Filings, Opinions And Approvals

 
• By Saba Afreen

<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>

EU Pharma Reform: What You Need to Know Now

 
• By Anabel Costa-Ferreira and Ian Schofield

As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

New EU Approvals

<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

More from Geography

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

Nancy Test Circulable Section Geography

 
• By Brian Bossetta

This is a short description