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FDA sued for approving high dose of Eisai's Alzheimer’s drug Aricept

Consumer rights group Public Citizen claims the high-strength dose is unsafe

The US Food and Drug Administration (FDA) is facing a lawsuit from a consumer rights group over its decision to allow a “dangerous” dose of Eisai's Alzheimer's drug Aricept onto the market.

Public Citizen claims that a 23mg version of the drug, approved in 2009, is no more effective than previously available lower doses, but is more likely to cause severe side effects, such as vomiting, that can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture and even death.

According to the group, the primary medical reviewer at the FDA had initially recommended the regulator deny Eisai's licence application for the higher dose, but this was rejected by the director of the FDA's Division of Neurology Products, Dr Russell Katz. Consequently Eisai gained extra time to exclusively market the drug without facing generic competition.

Prior to launching the lawsuit, Public Citizen sent the FDA a petition in May 2011 calling for the 23mg version to be pulled from the market, and to add a warning to lower dose versions of Aricept and its generic copies advising against use of the drug at a higher dose. However, the FDA is yet to act on this petition.

“By ignoring Public Citizen's petition for more than a year, the agency has ignored this responsibility and instead has chosen to support the profit interests of a large pharmaceutical company,” said Dr Sidney Wolfe, director of Public Citizen's health research group.

“During the past year alone approximately 350,000 prescriptions have been filled in the US for Aricept 23, with total sales of $91m. Allowing Eisai to exploit and harm vulnerable patients with Alzheimer's disease is unconscionable.”

Responding to the lawsuit, an FDA spokesperson said the agency does not comment on pending litigation.

Eisai spokesperson Marcia Diljak also declined to comment on the lawsuit to Bloomberg, but told the news agency: “We stand by the FDA's decision to approve Aricept 23mg as a safe and effective treatment of moderate to severe Alzheimer's disease.”

7th September 2012

From: Regulatory

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