High doses of Alzheimer's drug Aricept should be banned, Public Citizen says

May 19, 2011 By Thomas H. Maugh II

High doses of the Alzheimer's drug Aricept should be banned because they are no more effective than low doses and have a sharply increased risk of adverse effects, the advocacy group Public Citizen and a Johns Hopkins University geriatrician said Wednesday in a petition to the Food and Drug Administration.

Aricept, known generically as donepezil, is one of the very few drugs available for treating Alzheimer's disease, but it provides only a very modest slowing in the cognitive and functional deficits associated with the disease. Yet the is widely used "due primarily to two factors: the understandable desperation of those who care for patients with Alzheimer's disease and a relentless promotional campaign by drug companies," said co-petitioner Dr. Thomas Finucane of Hopkins.

Aricept has been approved by the FDA in dosages of 5 to 10 milligrams for patients with mild to moderate cases of Alzheimer's and in a dose of 10 to 23 milligrams for more severe cases. The petition asks the FDA to ban the 23-mg version of the drug and to warn patients and physicians against taking two 10-mg. pills per day if the higher dosage is removed from the market.

Clinical trials of Aricept submitted to the FDA for approval show no significant benefit from the 23-mg version compared to the 10-mg version, the petition said. But the increased from the higher dosage include a slowed , nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness, agitation, confusion and anorexia. Vomiting, which occurred more than 3 { times more frequently in those taking the high dosage, is a particularly dangerous side effect for Alzheimer's patients, the petition says, because it can lead to pneumonia, massive , esophageal rupture and even death.

"With no evidence of an added advantage in benefit to patients, the clear increase in risk should have been more than adequate grounds for denying approval," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "It is inexcusable that FDA approved this higher dose. Its prompt removal would belatedly fulfill the agency's mission to allow only drugs whose benefits outweigh their risks to be marketed."

Public Citizen has a long history of campaigning against drugs that it considers dangerous or ineffective.

Explore further: Zogenix says former obesity drug reduced seizures in study

0 shares

Related Stories

FDA approves larger dose of Pfizer's Aricept

Jul 25, 2010

(AP) -- Drugmakers Eisai Inc. and Pfizer Inc. said on Saturday that government regulators have given them permission to make a larger dose of its Alzheimer's disease drug Aricept for patients who have already been taking ...

Drug class not effective for Alzheimer's

Oct 12, 2006

A study funded by the National Institute of Mental Health in Bethesda, Md., says antipsychotic drugs used to treat Alzheimer's patients are mostly ineffective.

Watchdog group makes 2nd push to ban diet pill

Apr 18, 2011

(AP) -- For the second time in five years, public health advocates are calling on the Food and Drug Administration to ban a fat-blocking drug sold over-the counter and via prescription, pointing to new reports of kidney ...

Recommended for you

Obese British man in court fight for surgery

Jul 11, 2011

A British man weighing 22 stone (139 kilograms, 306 pounds) launched a court appeal Monday against a decision to refuse him state-funded obesity surgery because he is not fat enough.

2008 crisis spurred rise in suicides in Europe

Jul 08, 2011

The financial crisis that began to hit Europe in mid-2008 reversed a steady, years-long fall in suicides among people of working age, according to a letter published on Friday by The Lancet.

New food labels dished up to keep Europe healthy

Jul 06, 2011

A groundbreaking deal on compulsory new food labels Wednesday is set to give Europeans clear information on the nutritional and energy content of products, as well as country of origin.

Overweight men have poorer sperm count

Jul 04, 2011

Overweight or obese men, like their female counterparts, have a lower chance of becoming a parent, according to a comparison of sperm quality presented at a European fertility meeting Monday.

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.