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:6/23/2016)... ... June 23, 2016 , ... ... regulatory and technical consulting, provides a free webinar on Performing Quality ... 13, 2016 at 12pm CT at no charge. , Incomplete investigations are still ...
(Date:6/23/2016)... , June 22, 2016  Amgen (NASDAQ: ... of the QB3@953 life sciences incubator to ... health. The shared laboratory space at QB3@953 was created ... a key obstacle for many early stage organizations - ... of the sponsorship, Amgen launched two "Amgen Golden Ticket" ...
(Date:6/22/2016)... , June 22, 2016 Cell ... will allow them to produce up to one ... one lot within one week. These high-quality, consistent ... laboriously preparing cells and spend more time doing ... through a proprietary, high-volume manufacturing process that produces ...
(Date:6/22/2016)... 2016  According to Kalorama Information, the dominant ... market include significant efforts in automation as well ... and affordable sequencers, say the healthcare market research ... including sample prep materials.  The healthcare market research ... for Next Generation Sequencing (NGS) , highlights major ...
Breaking Biology Technology:
(Date:4/13/2016)... physicians supporting Medicaid patients in Central Florida ... telehealth thanks to a new partnership with higi.   ... can routinely track key health measurements, such as blood ... they opt in, share them with IMPOWER clinicians through ... location at no cost. By leveraging this data, IMPOWER ...
(Date:3/31/2016)... , March 31, 2016  Genomics firm Nabsys ... founding CEO, Barrett Bready , M.D., who returned ... of the original technical leadership team, including Chief Technology ... of Product Development, Steve Nurnberg and Vice President of ... to the company. Dr. Bready served as ...
(Date:3/23/2016)... , March 23, 2016 ... erhöhter Sicherheit Gesichts- und Stimmerkennung mit Passwörtern ... (NASDAQ: MESG ), ein führender ... das Unternehmen mit SpeechPro zusammenarbeitet, um erstmals ... Finanzdienstleistungsbranche, wird die Möglichkeit angeboten, im Rahmen ...
Breaking Biology News(10 mins):