McPhadden Samac Tuovi LLP is investigating possible claims against Merck in relation to its blockbuster drugs Vytorin and Zetia. Zetia has been marketed in Canada under the name Ezetrol.
Vytorin is a drug combination composed of Zetia and Simvastatin used for the treatment of dyslipidemia. Dyslipidemia is an abnormal amount of lipids such as cholesterol and/or fat.
On December 14, a committee at the FDA rejected Merck’s applications to expand the approved uses of the two drugs. Missing clinical trial information was one of the factors in the committee’s rejection of expanded approved uses.
The applications were based on the results of the IMPROVE-IT trial (IMProved Reduction of Outcomes:Vytorin Efficacy International Trial), a large, multicenter, long-term trial designed to assess the cardiovascular outcomes benefit of further low-density lipoprotein cholesterol lowering through the addition of the cholesterol absorption inhibitor ezetimibe to statin treatment in subjects at high risk for recurrent cardiovascular events.
The missing information is identified at page 12 of an FDA briefing document found at this link: http://goo.gl/9Ltahu
The missing information from IMPROVE-IT raises questions about how the information came to be lost and whether the missing information would have had a bearing on existing approved uses or on the warnings provided in respect of currently approved uses, particularly as regards heart and cancer events.
MCST would like to speak to anyone who has suffered such an event after taking Vytorin and Zetia. MCST would also like to speak to any Merck employees or representatives with knowledge about the missing information and marketing efforts for those drugs in Canada. People with information or who have suffered a heart event or developed cancer may contact the law firm in confidence at 416-601-1020 or at firstname.lastname@example.org .
At this link is a questionnaire that may be completed to provide your information in confidence: