Aricept Recall Petition Filed by Public Citizen for High-Dose Version

The prominent consumer watchdog Public Citizen is calling for a recall of Aricept 23 milligram, arguing that the higher dose of the medication used to treat Alzheimer’s disease lacks effectiveness and carries too many side effects. 

Public Citizen filed the Aricept recall petition with the FDA on May 18, asking the federal agency to ban 23 milligram (mg) doses of Aricept from the market. The petition does not ask the agency to remove the 5 to 10 mg doses of the drug.

According to the non-profit group, the side effects of Aricept in the 23 mg dose are far more toxic than at lower doses, and there appears to be little clinical benefit from using the higher doses over the lower ones. High dose Aricept side effects can include lowered pulse, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness, agitation, confusion and anorexia, Public Citizen claims.

Public Citizen’s Health Research Group director, Dr. Sidney Wolfe, said in a press release that the vomiting was particularly dangerous for elderly Alzheimer’s patients. It occurs 3.5 times more often with higher Aricept doses than with lower doses, and the repeated vomiting can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture and death, he said.

Only one clinical trial for 23 mg Aricept has been submitted to the FDA and Public Citizen notes that it failed to show that the 23 mg version was more effective than lower doses. In three out of four tests, there was no significant difference between the 10 mg and 23 mg doses in patients’ cognitive or functional level, and on the fourth test the difference was about 2 points on a scale of 100, which Wolfe says is not clinically important.

Aricept (donepezil) was developed by Pfizer and Eisai and was first approved for the treatment of Alzheimer’s disease in 1996. The 23 mg Aricept treatment was approved by the FDA over the objections of Dr. Ranjit B. Mani (pdf), an FDA medical reviewer, and the objections of Tristan Massie (pdf), an FDA statistical reviewer, in 2010.

Public Citizen has served as an important consumer watchdog in recent years, often requesting the recall of dangerous medications or warning about potential side effects long before federal regulators take any actions.

In 2006, the group filed a petition for the FDA to remove Darvon and Darvocet from the market after the painkillers were linked to thousands of deaths. Two years later, in 2008, Public Citizen filed a lawsuit against the FDA for failing act on the petition. In November 2010, the FDA finally decided to issue a Darvon and Darvocet recall, indicating that the medications only provide minimal pain relief and increase the risk of serious and potentially life-threatening heart problems