Drug warnings issued by the Food and Drug Administration lead some patients to eschew their medication regimens, even if the FDA didn't advise health professionals to stop prescribing those medicines, research from CVS Caremark Corp. found.


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Unclear FDA drug warnings hurt adherence, CVS research finds

May 23rd, 2012

WOONSOCKET, R.I. – Drug warnings issued by the Food and Drug Administration lead some patients to eschew their medication regimens, even if the FDA didn't advise health professionals to stop prescribing those medicines, research from CVS Caremark Corp. found.

The company said Wednesday that its research with Harvard University and Brigham and Women's Hospital examined the effects of FDA drug alerts on medication adherence when the warnings aren't delivered with clear clinical recommendations.

The study revealed that immediately after a high-profile FDA communication questioning the efficacy for a cholesterol-lowering drug, the monthly level of patients who stopped filling their prescription rose nearly 6%. In addition, of patients who stopped taking the drug after the FDA warning, only 16.5% switched to another clinically appropriate therapy.

"This study provides an interesting perspective on how information made available to both health care practitioners and patients about the effectiveness of a drug can impact patient behavior and result in nonadherence," Troy Brennan, executive vice president and chief medical officer at CVS Caremark, said in a statement. "The results suggest that a more robust understanding of how and why patients respond to drug information could lead to even more effective public health warnings regarding new data about medications."

Researchers from Harvard, Brigham and Women's Hospital and CVS Caremark reviewed the impact of an FDA communication made on Jan. 25, 2008, regarding ezetimibe, a cholesterol-lowering medication. 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 didn't appear to improve patient outcomes. The FDA questioned about the effectiveness of the drug in its communication but didn't advise health care professionals to discontinue prescribing these products. The communication drew substantial media attention.

"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," explained study co-author Niteesh Choudhry, M.D., of Brigham and Women's Hospital. "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."

Results of the study, titled "Warnings without guidance: Patient responses to an FDA warning about ezetimibe," were published in the June 2012 issue of the journal Medical Care.

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