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FDA Questions Safety of GSK's Kidney Cancer Drug over Fatal Liver Risks
pine Webmaster of Pineapple
2009/10/02 00:42
508 topics published
10/2/2009 Provided by CnYES
The U.S. Food and Drug Administration (FDA) stated that the experimental kidney cancer drug from GlaxoSmithKline Plc. (GSK-UK, GSK-US; GSK), the world's second-largest pharmaceutical company, may cause liver problems, potentially overshadowing the drug's benefits in slowing the progression of kidney cancer.
Based in London, GSK submitted the drug to the FDA for approval in treating advanced kidney cancer.
In an online document, the FDA noted that reviewers found the drug slowed cancer progression, but patients did not show a significant increase in survival time.
The FDA also highlighted three fatal conditions linked to liver damage that the drug may cause, along with other side effects such as high blood pressure, internal bleeding, and blood clots.
On Monday, the FDA will consult an expert panel on whether to approve the drug. Although the FDA is not obligated to follow the panel's advice, it typically heeds expert recommendations.
As of 12:03 Taipei time, GSK's stock price on the New York Stock Exchange fell by $0.40 or 1.01%, to $39.11.
Source:
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