Drug Safety Developments

Consumer group sues FDA over Aricept safety

Quoted from http://news.findlaw.com/apnews/52209a3af4dc40e89c5b6e9d4fdc66fb

Consumer group sues FDA over Aricept safety

By LINDA A. JOHNSON

TRENTON, N.J. (AP) — A consumer group pressing the Food and Drug Administration to remove the highest dose of an Alzheimer's disease drug from the market is suing the agency for what it calls "foot-dragging."

Public Citizen said Wednesday that the FDA's own medical and statistical reviewers found that high-dose Aricept doesn't work better at controlling symptoms of moderate-to-severe Alzheimer's than two low doses.

However, the group said the high dose has more-dangerous, potentially deadly side effects including vomiting, which in Alzheimer's patients "can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death." Other side effects more common at the high dose are nausea, diarrhea, anorexia and confusion.

Public Citizen filed a petition in May 2011 with the FDA. The group urged the agency to halt sales of the 23-milligram dose of Aricept and put safety warnings about the high-dose risks on two low doses, 5 and 10 milligrams. The low doses are available under both the Aricept brand, made by Japan's Eisai Co. Ltd., and as inexpensive generic pills.

The FDA has yet to act.

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Drug Dosage Was Approved Despite Warning

Quoted from http://www.nytimes.com/2012/03/23/business/drug-dosage-was-approved-despite-warning.html

Drug Dosage Was Approved Despite Warning

By KATIE THOMAS

Published: March 22, 2012

Four months before a best-selling Alzheimer’s drug was set to lose its patent protection, its makers received approval for a higher dosage that extended their exclusive right to sell the drug. But the higher dosage caused potentially dangerous side effects and worked only slightly better than the existing drugs, according to an article published Thursday in the British Medical Journal.

 

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Eisai, via Business Wire

Aricept 23 was developed by the Japanese pharmaceutical company Eisai and is marketed in the United States through a partnership with Pfizer.

 

They noted that the clinical trial had failed to show that the higher dosage — 23 milligrams versus the previous dosages of 5 and 10 milligrams — met its goals of improving both cognitive and overall functioning in people with moderate to severe Alzheimer’s disease.

The single clinical trial of 1,400 patients also found that the larger dosage led to substantially more nausea and vomiting, potentially dangerous side effects for elderly patients struggling with advanced Alzheimer’s disease. The drug was developed by the Japanese pharmaceutical company Eisai but is marketed in the United States in a partnership with Pfizer.

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