Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Alzheimer's Disease Health Center

Font Size

11 Aricept Deaths in Clinical Trial

Excess Deaths in Vascular Dementia Patients Taking Alzheimer's Drug
WebMD Health News
Reviewed by Louise Chang, MD

March 17, 2006 - There were 11 deaths in vascular dementia patients taking the Alzheimer's drug Aricept in a clinical study -- and no deaths in patients taking inactive placebo pills.

The report comes from Aricept maker Eisai Co. Ltd., Tokyo, which sells Aricept in partnership with U.S.-based Pfizer. In the U.S., Aricept is approved for the treatment of mild-to-moderate Alzheimer's disease.

In the trial, there were 11 deaths among 648 vascular dementia patients taking Aricept and zero deaths among 326 patients given placebo in the 24-week study. That's a striking difference. But it may very well be due to a surprisingly low death rate in the placebo group -- and not to any previously unknown risk from Aricept.

No Need for Warning

The FDA is looking at the data but currently finds no reason to issue a warning, says FDA spokeswoman Susan Cruzan.

"FDA is examining the results of the study. We have done a quick review of it and at this point we don't have a major cause of concern," Cruzan tells WebMD. "The drug remains a safe option for patients who are receiving it."

Eisai spokeswoman Judee Shuler notes that the study is the third clinical trial of Aricept in vascular dementia patients. When all three studies are considered together, the death rate among those taking Aricept was 1.7% vs. a 1.1% death rate in placebo recipients. That difference is not statistically significant, meaning it's likely due to chance.

"It is Eisai's position that the results of this study do not change the overall safety profile of Aricept," Shuler tells WebMD. "The safety profile of Aricept continues to be favorable for its approved indication [for mild-to-moderate Alzheimer's disease]."

What Doctors Say

WebMD asked two leading dementia experts what they thought about the Aricept news:

  • Sid Gilman, MD, director of the Michigan Alzheimer's Disease Research Center and distinguished professor of neurology at the University of Michigan, Ann Arbor.
  • Howard S. Kirshner, MD, professor and vice chairman of neurology at Vanderbilt University in Nashville, Tenn.

Gilman and Kirshner both note that Aricept -- like its sister drugs, Razadyne, Exelon, and Cognex -- increases acetylcholine, a chemical messenger. In the brain, acetylcholine may help memory. But it also may slow down the heart. In the elderly, this increases the risk of potentially deadly heart problems.

Patients with vascular dementia are particularly prone to heart attack and stroke. So while the drugs may very well provide a benefit, they also come with an increased risk. Shuler notes that Aricept did indeed improve mental function in vascular dementia patients, but it did not improve measures of overall function.

Today on WebMD

Remember your finger
When it’s more than just forgetfulness.
senior man with serious expression
Which kinds are treatable?
senior man
Common symptoms to look for.
mri scan of human brain
Can drinking red wine reverse the disease?
eating blueberries
Colored mri of brain
Close up of elderly couple holding hands
mature woman
Woman comforting ailing mother
Senior woman with serious expression