Navigation Links
Pfizer Stops Clinical Trials of Thelin® and Initiates Voluntary Product Withdrawal in the Interest of Patient Safety
Date:12/10/2010

NEW YORK, Dec. 10, 2010 /PRNewswire-FirstCall/ -- Pfizer Inc. (NYSE: PFE) announced today that, in the interest of patient safety, it is voluntarily withdrawing Thelin® (sitaxentan) for the treatment of pulmonary arterial hypertension (PAH) in regions where it is approved (the European Union, Canada and Australia).  In addition, Pfizer is discontinuing clinical studies of Thelin worldwide.

(Logo: http://photos.prnewswire.com/prnh/20100416/PFIZERLOGO)

Pfizer's decision was based on a review of emerging safety information from clinical trials and post-marketing reports.  While liver toxicity is a known complication of the class of drugs to which Thelin belongs, a new potentially life-threatening idiosyncratic risk of liver injury with Thelin has been observed. Given the availability of alternate treatments, Pfizer has concluded that the overall benefit of Thelin no longer outweighs the risk in the general population of PAH patients.  The Company has notified health authorities about this finding and its decision to voluntarily withdraw Thelin from the market and stop clinical studies.  

"Pfizer's priority is to ensure the safety and well-being of patients, and we are in the process of communicating all of this information to the appropriate medical professionals and regulatory authorities in all regions as quickly as possible," said Cara Cassino, MD, vice president, Clinical Development and Medical Affairs for Pfizer's Pulmonary Vascular Disease unit.

Pfizer recommends that no new patients be prescribed Thelin and that patients receiving Thelin be transitioned to appropriate alternate therapies as soon as safely possible according to best local practice.  Patients taking Thelin or participating in Thelin studies are advised to consult with their health care professional as soon as possible.  Patients should not stop taking Thelin until they speak to their health care professional.  

For further information, contact the local Pfizer Country office. (Pfizer country websites can be accessed at http://www.pfizer.com/general/global_sites.jsp.)

Thelin is approved in the European Union, Australia and Canada to treat patients with pulmonary arterial hypertension.  Pulmonary arterial hypertension is a rare, progressive, life-threatening disease that may result in heart failure and premature death.  Pfizer remains committed to research in pulmonary vascular disease.

Prescribing information for Thelin from countries where it is currently approved is available at the following links:


Pfizer Inc: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

About Pfizer's Specialty Care Business

Pfizer's Specialty Care Business Unit is the world's largest specialty pharmaceuticals business, with a commitment to the eradication, remission and relief of serious diseases. Pfizer's Specialty Care Business is committed to bringing together the best scientific minds to challenge the most feared diseases of our time. 


'/>"/>
SOURCE Pfizer Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Biovista Announces a Drug Repositioning Collaboration With Pfizer
2. MacroGenics Enters Global Research Collaboration and License Agreement with Pfizer
3. Pfizer, Merck, Roche/Genentech, GSK, J&J, BMS and More to Speak at Contracting & Outsourcing 2010
4. Pfizer Wins CIO 100 Award for Patient Enrollment Optimization Solution From DecisionView
5. Pfizer Announces EMPHASIS-HF Trial to Halt Recruitment due to Significant Benefit Observed in Patients Treated With Inspra® (Eplerenone)
6. Pfizer Animal Health Expands Global Commitment to a Safe Food Supply with a New Focus on Healthy Fish
7. Oramed Pharmaceuticals Announces That Dr. Michael Berelowitz, Senior Vice President at Pfizer, Joins its Board of Directors
8. Pfizer Global Manufacturing Announces Plans to Reconfigure Its Global Plant Network
9. Anavex comments on failure of Pfizer and Medivations Alzheimers investigational drug Dimebon during Phase 3 clinical trials
10. Wyeth Announces Stockholder Approval of Pfizer Merger at 2009 Annual Meeting
11. Pfizer Global R&D Presents 2008 Top Intermediates CMO Award to Asymchem
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/16/2017)... ... January 16, 2017 , ... Attagene , a Research ... U.S. Small Business Administration. The Tibbetts Award honors the Small Business Innovation ... and are considered the best of the best from the thousands of firms ...
(Date:1/13/2017)... Research and Markets has announced the addition ... Forecast to 2021" report to their offering. ... The biosimilars market is expected ... in 2016, at a CAGR of 26.3%. The ... type, and application. Factors such as rising incidence of various diseases, ...
(Date:1/13/2017)... ... January 13, 2017 , ... FireflySci, in response to ... three new solutions for measurements where traditional cuvette applications are not convenient. For ... an oddly-shaped sample that would not fit into a typical cuvette inside a ...
(Date:1/12/2017)... NE (PRWEB) , ... January 12, 2017 , ... ... hiring of Stephen Beck, who will work in the company’s Lincoln office as a ... chemical processes to design control systems for customers in the life science manufacturing and ...
Breaking Biology Technology:
(Date:1/13/2017)... 2017 Sandata Technologies, LLC, a leading ... industry, including Electronic Visit Verification™ (EVV™), announced today ... as Senior Vice President of Product Management. ... homecare experience to Sandata, where he will be ... align Sandata,s suite of solutions with the needs ...
(Date:1/12/2017)... , Jan. 12, 2017  Trovagene, Inc. (NASDAQ: ... DNA (ctDNA) technologies, today announced that it has signed ... and the Middle East ...  This milestone marks the first wave of international distribution ... urine and blood samples. The initial partners ...
(Date:1/12/2017)... YORK , Jan. 12, 2017  New research undertaken ... the office of the future.  1,000 participants were simply asked ... three months which we may consider standard issue.  Insights on ... of 2017 were also gathered from futurists and industry leaders ... Dr. James Canton .  Some of ...
Breaking Biology News(10 mins):