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CVS Caremark Sponsored Research Finds FDA Drug Warnings Can Have Immediate Negative Impact on Medication Adherence, Even if Not Related to Safety
Date:5/23/2012

WOONSOCKET, R.I., May 23, 2012 /PRNewswire/ -- New research sponsored by CVS Caremark examined the effects of Food and Drug Administration (FDA) drug warnings on medication adherence when the warnings are not delivered with clear clinical recommendations. The research found that immediately following a high-profile FDA communication questioning the efficacy for a cholesterol-lowering drug, the monthly level of patients who stopped filling their prescription increased by nearly 6 percent. In addition, of those patients who stopped taking the drug after the FDA warning, only 16.5 percent switched to another clinically appropriate therapy.

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"These findings suggest that when an FDA communication about a prescription drug is widely reported in the news media and is not related to a safety issue or accompanied by clear guidelines about how to apply this information, the resulting confusion can bluntly reduce overall rates of treatment," said Niteesh Choudhry, MD, PhD of Brigham and Women's Hospital, a study co-author.  "Furthermore, if patients respond to this information by stopping therapy altogether and do not switch to another clinically appropriate medication there could be a negative impact on health outcomes which runs contrary to the intent of the initial communication."  

Researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark, reviewed the impact of an FDA communication made on January 25, 2008 regarding the cholesterol-lowering medication, ezetimibe. The FDA issued an early communication after results from the ENHANCE trial indicated that adding ezetimibe (known as either Zetia or the ezetimibe-simvastatin combination, Vytorin) to a treatment regimen including simvastatin did not appear to improve patient outcomes. The FDA raised questions about the effectiven
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