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UPDATE 1-Europe starts safety probe into Takeda's Actos
Fri, 18th Mar 2011 12:53
LONDON, March 18 (Reuters) - European regulators have launched an investigation into the safet
The European Medicines Agency said on Friday its experts would examine the benefit-risk balance of the drug, known generically as pioglitazone.
The bladder cancer risk has been under close review ever since Actos was approved in 2000 and Takeda is conducting a 10-year study looking at cancer rates in diabetic patients on the medicine.
Three interim study reports have so far have not confirmed a clear association between Actos and bladder cancer -- but the European agency said an increased number of spontaneous reports had prompted it to start the latest review.
Actos belongs to the same drug class as GlaxoSmithKline's Avandia, which was pulled from the market in Europe last year and faces stringent restrictions in the United States after being linked to heart risks.
(Reporting by Ben Hirschler; editing by Kate Kelland) Keywords: TAKEDA EUROPE/
(ben.hirschler@thomsonreuters.com; Tel: +44 20 7542 5082; Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net; www.twitter.com/reutersBenHir)
COPYRIGHT
Copyright Thomson Reuters 2011. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
y of Takeda's diabetes drug Actos, following a possible link to increased bladder cancer risk.
The European Medicines Agency said on Friday its experts would examine the benefit-risk balance of the drug, known generically as pioglitazone.
The bladder cancer risk has been under close review ever since Actos was approved in 2000 and Takeda is conducting a 10-year study looking at cancer rates in diabetic patients on the medicine.
Three interim study reports have so far have not confirmed a clear association between Actos and bladder cancer -- but the European agency said an increased number of spontaneous reports had prompted it to start the latest review.
Actos belongs to the same drug class as GlaxoSmithKline's Avandia, which was pulled from the market in Europe last year and faces stringent restrictions in the United States after being linked to heart risks.
(Reporting by Ben Hirschler; editing by Kate Kelland) Keywords: TAKEDA EUROPE/
(ben.hirschler@thomsonreuters.com; Tel: +44 20 7542 5082; Reuters Messaging: ben.hirschler.thomsonreuters.com@reuters.net; www.twitter.com/reutersBenHir)
COPYRIGHT
Copyright Thomson Reuters 2011. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
