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Regulatory Focus™ > News Articles > BMJ: Despite Warning, FDA Approved Higher-Dose Aricept

BMJ: Despite Warning, FDA Approved Higher-Dose Aricept

Posted 23 March 2012 | By Alexander Gaffney, RAC 

An article in The British Medical Journal (BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times.

FDA review staff noted their concerns about the drug's safety and efficacy, according to The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding a substantial increase in side effects.

Despite recommendations from a clinical reviewer and statistical review at FDA, Aricept 23 was ultimately approved by the Director of FDA's neurology products division, Dr. Russell Katz in July 2010.

The choice was not one that benefited patients, argued Dr. Steven Woloshin, the BMJ article's author.

"It doesn't really have much benefit, but does substantially more harm," said Woloshin.

Sidney Wolfe of the group Public Citizen Agreed with Woloshin's assessment.

"Rarely do we see such a dangerous difference between what pretty much everyone in the neurological division thought and what its leader thought," said Wolfe. "That's a huge slap in the face to all the people who spent much more time reviewing this drug than he did."

Read more:

New York Times - Drug Dosage Was Approved Despite Warning

BMJ - How the FDA forgot the evidence: the case of donepezil 23 mg


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