FDA Broadens Use of Alzheimer's Drug

Oct. 17, 2006 -- The FDA has expanded the approved uses of the Alzheimer's drug Aricept.

Aricept may now be used to treat severe Alzheimer's dementiadementia. It was already approved to treat mild to moderate Alzheimer's dementia.

That makes Aricept "the first product approved for the treatment of all degrees of severity of the disease," the FDA says in a news release.

"Alzheimer's diseaseAlzheimer's disease is a devastating, age-associated brain disorder that affects an estimated 4.5 million Americans -- and, as our population grows older, this number is expected to multiply," says Steven Galson, MD, MPH, in the FDA's news release.

Galson directs the FDA's Center for Drug Evaluation and Research.

Aricept's new approval "makes available another treatment for those with severe dementia," Galson says.

The FDA approved Aricept for severe Alzheimer's dementia based on two clinical studies conducted in Sweden and Japan.

The studies lasted six months and included more than 500 patients with severe Alzheimer's disease.

The patients were randomly assigned to take Aricept or a pill lacking medicine (placebo).

To determine Aricept's effectiveness, the researchers evaluated the patients on two measures: mental functions (such as memory, language, and attention) and overall functioning.

The patients taking Aricept performed better on both measures than those taking the placebo, according to the FDA.

The most commonly reported adverse events in patients taking Aricept in the Swedish study were diarrheadiarrhea, appetite loss, vomiting, nausea, and bruising, according to drug companies Eisai Inc. and Pfizer.

Eisai makes Aricept and co-promotes the drug in the U.S. with Pfizer. Pfizer is a WebMD sponsor.

Aricept is not a cure for Alzheimer's dementia, but it can "help slow down the progression of symptoms, including memory loss," states an Eisai and Pfizer joint news release.

Aricept "is well tolerated but may not be for everyone," the release states.

The drug companies say that "people at risk for stomach ulcersulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse."

Some people who take Aricept may experience fainting, nausea, vomiting, diarrhea, bruising, sleep problems, muscle cramps, appetite loss, or tiredness.

Eisai and Pfizer say that those side effects "were mild and temporary" in studies of Aricept.