Consumer group sues FDA for not banning dangerous dose of Alzheimer’s drug
September 06, 2012
In a lawsuit, Public Citizen is asking that the U.S. Food and Drug Administration stop allowing the drug Aricept to be marketed at doses that can cause severe – and even fatal – side effects.
In May 2011, Public Citizen filed a petition urging the FDA to immediately remove from the market a 23 milligram dose of Aricept and to add to lower-dosage – 5 mg and 10 mg – forms of Aricept and the generic, donepezil, warnings against use at a higher dosage.
A study presented to the FDA in 2009 failed to show that the 23 mg version was more effective than lower doses, Public Citizen, a consumer advocacy group, said in a statement. But the high dose was associated with a much higher incidence of vomiting, which, in patients with Alzheimer’s disease, “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death,” according to the FDA.
Aricept was approved in 1996 as a treatment for Alzheimer’s at a dose of 5 or 10 mg daily. Before the patent expired in November 2010, the drug maker, Eisai, asked for approval for a 23 mg version, so it would have an additional period to market Aricept without generic competition, Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group, said.
Public Citizen is asking the court to decide that the FDA’s failure to act on its petition is unlawful and to order the FDA to issue a decision on the petition.
By not acting on Public Citizen’s petition, the FDA has ignored its responsibilities and instead has chosen to support the profit interests of a large pharmaceutical company, Wolfe said.
“During the past year alone approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23, with total sales of $91 million,” he said. “Allowing Esai to exploit and harm vulnerable patients with Alzheimer’s disease is unconscionable.”
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