FDA Rejects Petition to Remove 23 milligram Aricept from Market

As we reported earlier this month, a consumer advocate group, Public Citizen’s Health Research Group, has petitioned the U.S. Food and Drug Administration (FDA) to remove the highest dose of an Alzheimer disease drug from the market, but says that the FDA has rejected its request.

On Tuesday, a Public Citizen spokesperson said that the FDA declined to withdraw the 23 milligram Aricept, manufactured by Japan’s Eisai Co. Lt, following a lawsuit filed against the agency.

The consumer advocacy group first began petitioning the agency regarding Aricept in May 2011, saying that 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.”  The group asked the FDA to halt sales of the highest dose of Aricept and put safety warnings about the high dose risks on low doses of 5 and 10 milligrams.

In September, the group filed a lawsuit in federal court to urge the FDA to respond to the petition. The agency denied their request in a letter sent to the group Tuesday.  “Allowing drug manufacturer Eisai to exploit and harm vulnerable patients with Alzheimer’s disease is unconscionable,” said Sidney Wolfe, director of Public Citizen’s Health Research Group, in a statement. He noted that Aricept is the best-selling Alzheimer’s drug of all time, with sales of $2.4 billion in 2010. Sales have declined since the drug lost its patent protection in the U.S.

The FDA had initially said that to be approved, Aricept 23 milligrams would have to improve both cognitive and global (overall) functioning in patients with the disease. However, a clinical trial found only a slight improvement cognitively and clinical and statistical reviewers for the FDA each recommended against approving Aricept 23 milligrams. For some reason, the director of their division at the FDA overruled them and approved the drug anyway.  Dr. Russell Katz, director of the FDA’s neurological products division, acknowledged that side effects from the higher dose “could lead to significant morbidities and even increase mortality,” but concluded that the drug most likely improved overall functioning, even though the study did not show that.

Patients suffering from this terrible disease are vulnerable and their family members are desperate for hope. The FDA is supposed to protect consumers in our country. If they have any doubt that this stronger dosage of Aricept can potentially harm or kill a person, how can they allow this product to remain on the market?  Feel free to comment on this blog post. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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