Press Release: Thelin (sitaxentan) to be withdrawn due to cases of unpredictable serious liver injury

Author (Corporate)
Series Title
Series Details EMA/804365/2010 (10.12.10)
Publication Date 10/12/2010
Content Type

The European Medicines Agency (EMA) was informed, in December 2010, of Pfizer’s decision to voluntarily withdraw Thelin from the market worldwide further to new information on two cases of fatal liver injury. Pfizer had also decided to discontinue all ongoing clinical trials.

Thelin, which contains the active substance sitaxentan, has been authorised in the European Union (EU) since 2006 for the treatment of pulmonary arterial hypertension.
Source Link http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/12/news_detail_001161.jsp&mid=WC0b01ac058004d5c1&murl=menus/news_and_events/news_and_events.jsp
Related Links
EMA: Public Statement: EMA/149536/2011 (2.3.11)Public statement on Thelin: Withdrawal of the marketing authorisation in the European Union http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2011/03/WC500102595.pdf
EMA: Press Release: EMA/804365/2010 (10.12.10) http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/12/WC500099707.pdf
EMA: Press Release; EMA/CHMP/819948/2010 (16.12.10): Update on the withdrawal of Thelin http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2010/12/WC500099940.pdf
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