{"id":112848,"date":"2009-12-22T13:41:56","date_gmt":"2009-12-22T18:41:56","guid":{"rendered":"tag:typepad.com,2003:post-6a00d8341c89dd53ef0120a772b55d970b"},"modified":"2009-12-24T07:40:57","modified_gmt":"2009-12-24T12:40:57","slug":"fda-finds-it-unlikely-that-vytorin-or-zetia-increases-risk-of-cancer-but-such-a-link-is-possible","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/112848","title":{"rendered":"FDA Finds It Unlikely That Vytorin Or Zetia Increases Risk Of Cancer, But Such A Link Is Possible"},"content":{"rendered":"
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December 2009 Update From FDA For Its August 2008 Early Communication About Safety Review of Ezetimibe \/ Simvastatin (Vytorin) And Ezetimibe (Zetia)<\/span><\/span><\/span><\/strong> <\/p>\n

(Posted by Tom Lamb at DrugInjuryWatch.com<\/strong><\/font><\/span><\/a>)<\/strong><\/font><\/strong><\/font><\/span><\/span><\/span><\/span> <\/p>\n

On December 22, 2009 the FDA issued an update about its August 2008 Early Communication which described a possible association between the use of Vytorin \u2013 a combination of simvastatin (Zocor) and ezetimibe (Zetia) \u2013 and an increased risk of cancer and cancer-related death compared to placebo.<\/p>\n

As you may recall, that August 2008 Early Communication was based on preliminary results from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial.<\/p>\n

From the December 2009 safety update about Vytorin and Zetia, which is titled “Follow-Up to the August 2008 Early Communication About an Ongoing Safety Review of Ezetimibe\/Simvastatin (marketed as Vytorin), Simvastatin (marketed as Zocor) and Ezetimibe (marketed as Zetia) – FDA Investigates a Report from the SEAS Trial”<\/a>:<\/p>\n

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FDA has now completed its review of the data from the SEAS trial as well as a review of interim data from two large-scale ongoing cardiovascular trials with Vytorin – the SHARP and IMPROVE-IT trials. Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitively ruled out….\u00a0 [footnotes omitted]<\/p>\n

The SHARP trial is placebo-controlled, but uses a lower dose of Vytorin (10\/20 mg) than was used in the SEAS trial. The IMPROVE-IT trial compares Vytorin 10\/40 mg to simvastatin 40 mg. An interim analysis of the cancer data from these two trials, which includes a total of 20,617 patients, did not show an increased risk of cancer with Vytorin. There was an increase in the number of cancer-related deaths, with 97 deaths in the Vytorin groups compared to 72 deaths in the control groups, but this finding was not statistically significant.<\/p>\n

When completed, the SHARP and IMPROVE-IT trials will provide additional data to further assess cancer risk with simvastatin and ezetimibe. The SHARP trial is expected to be completed in 2010 and IMPROVE-IT in 2012.<\/p>\n<\/blockquote>\n

As for other serious side effects which have been associated with Vytorin and Zetia, back in September 2008 we reported about two medical journal articles which described a case of liver disease involving Zeita and a case of liver failure possibly linked to Vytorin<\/a>.<\/p>\n

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DrugInjuryLaw.com<\/font><\/span><\/strong><\/a>: Legal Information And News About Prescription Drug Side Effects<\/strong><\/span><\/span><\/span><\/span><\/p>\n