FDA: Ban Aricept (high doses) for Alzheimer’s Disease?

Alzheimer’s disease is the breakdown and destruction of brain cells. There is no known cure for this disease, which worsens as it progresses, eventually leading to death. It is most often associated in people over age 65. In 2006, there were 26.6 million sufferers worldwide. Alzheimer’s is predicted to affect 1 in 85 people globally by 2050. Alzheimer’s is the 6th leading cause of death in the U.S.

Although there is currently no cure for this awful disease, treatments for symptoms are available and research continues. The current Alzheimer’s treatments cannot stop its progression, but can temporarily slow the worsening of dementia symptoms and improve quality of life for patients with Alzheimer’s and their caregivers. There continues to be worldwide efforts to find better ways to treat this disease, delay its onset and prevent it from developing.

There are 3 phases of the disease: mild, moderate and severe. While there is no cure, drugs such as Aricept, can ease symptoms.

Aricept, made by Pfizer and Eisai, has been approved by the U.S. Food and Drug Administration (FDA) at doses of 5-10 mg. for patients with mild to moderate Alzheimer’s disease and at doses of 10-23 mg. for more severe cases.

Public Citizen, a non-profit consumer advocacy group based in Washington, has petitioned the FDA to ban high doses of the Alzheimer disease drug, Aricept, claiming its risks far exceed its benefits. They say the higher doses endanger patients and do not enhance the treatment’s effectiveness.

Public Citizen has filed 34 petitions to ban drugs, 22 of which are off the market, said Sidney Wolfe, director of health research.

Public Citizen says that the adverse side effects of Aricept at the higher dose, which includes decreased heart rate and vomiting, negate its modest advantage over the lower dose.  But some doctors believe the higher dose should remain an option, since the lower dose does not provide adequate effectiveness in the treatment of this disease.

In the trial, on which the FDA based its approval, high dose Aricept modestly improved patient’s scores on a test that measures cognition. However, it also increased the side effects.

Aricept, manufactured by Pfizer and Eisai, and other generic cholinesterase inhibitors (which block the breakdown of neurotransmitters involved in memory and cognition) are considered the first line of defense in Alzheimer’s treatment.

“It is inexcusable that the FDA approved this higher dose. It’s prompt removal would belatedly fulfill the agency’s mission as part of the Public Health Service to only allow drugs whose benefits outweigh their risks to be marketed,” said Sidney Wolfe, director of Public Citizen’s Health Research Group, in a statement.

Public Citizen maintains that vomiting is a dangerous side effect for Alzheimer’s patients because it can lead to pneumonia.

U.S. regulators approved the 23 mg. dose in July, four months before a patent on Aricept’s 10 mg. dose expired. Patients taking the larger dose experienced more side effects than the 10 mg. level, including nausea, vomiting and gastrointestinal bleeding, according to the company’s website.

Wolfe also accuses the drug makers of pushing the higher dose Aricept for financial gain. “Given that a patent on Aricept, their big-selling, leading drug for Alzheimer’s disease, was due to expire in November 2010 and that Pfizer/Eisai judged they would quickly lose most of their market to less-expensive generic equivalents, what could they do? Getting a new patent on a previously unapproved higher dose, 23 mg., appeared to be the best idea,” Wolfe said in a statement.  Wolfe claims that the drug manufacturer Pfizer/Eisai “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.” Users are “getting something that’s gratuitously extra toxic,” he said.

Aricept prescriptions fell to 91,000 in March from 914,000 after the patent expired, Public Citizen said. Aricept accounted for $417 million of NY-based Pfizer’s sales last year and $323 million of Tokyo-based Eisai’s sales, data Bloomberg showed. Aricept is Eisai’s top selling treatment.

The 23 mg. dose of Aricept showed improvement over the 10 mg. dose on cognitive symptoms, though it didn’t show improvement on overall patient functioning, the companies said on the drug’s website.

Until the FDA knows that this stronger medication is safe, do you think it should remain on the market?  Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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