Higher doses of an Alzheimer’s drug sold by Eisai Co. and Pfizer Inc. (PFE) endanger patients and don’t enhance the treatment’s effectiveness, according to a consumer group that wants the regimen banned.
Public Citizen of Washington petitioned the Food and Drug Administration today to remove the 23 milligram dose of Aricept to treat moderate to severe Alzheimer’s from the U.S. market. The nonprofit organization has filed 34 petitions to ban drugs, 22 of which are off the market, said Sidney Wolfe, the director of health research.
U.S. regulators approved a 23 milligram dose in July, four months before a patent on Aricept’s 10 milligram dose expired. Patients taking the larger amount had more side effects than the 10 milligram level, including nausea, vomiting and gastrointestinal bleeding, according to the companies’ website.
“Eisai, Pfizer knew the patent was going to expire and since it was the leading Alzheimer’s drug, they wanted to figure out a way to retain their leading share,” Wolfe said. Users are “getting something that’s gratuitously extra toxic,” he said.
As many as 5.1 million Americans may have Alzheimer’s, the most common form of dementia in older people, according to the U.S. National Institutes of Health. While there’s no cure, drugs such as Aricept can ease symptoms.
The approval of the 23 milligram Aricept was based on data from a study of more than 1,400 patients with moderate to severe Alzheimer’s, said Raul Damas, a Pfizer spokesman. “It’s important for caregivers to have regular conversations with the patients’ health-care provider to discuss any new behavior or concerns and also reassess the patients’ treatment,” he said.
Thomas Finucane, a professor in the gerontology and geriatric medicine division at the Johns Hopkins University School of Medicine in Baltimore also signed the petition.
Aricept prescriptions fell to 91,000 in March from 914,000 after the patent expired, Public Citizen said. Aricept accounted for $417 million of New York-based Pfizer’s sales last year and $323 million of Tokyo-based Eisai’s sales, data Bloomberg compiled show. Aricept is Eisai’s top-selling treatment.
The 23 milligram dose of Aricept showed improvement over the 10 milligram amount on cognitive symptoms, though it didn’t show improvement on overall patient functioning, the companies said on the drug’s website.
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