Aricept Lawsuit Filed To Force FDA Action On Petition to Ban High Dose

The consumer watchdog group Public Citizen has filed a lawsuit against the FDA, seeking to force the federal drug regulatory agency to act on a petition filed to recall approval for high doses of Aricept, a medication for treatment of Alzheimer’s disease. 

The Aricept lawsuit was filed on September 5, asking a federal court to force the FDA to respond to Public Citizen’s petition, which was filed in May 2011.

The group asked the FDA to ban 23 milligram doses of Aricept and require new warnings on lower doses of the drug, due to the risk of serious and potentially life-threatening side effects. The complaint was filed because the FDA has taken no action on the petition to date.

“A primary function of the FDA is to protect citizens from harm caused by needlessly dangerous drugs, in this case a drug no more effective but significantly more dangerous than the lower doses of Aricept,” Public Citizen’s Health Research Group Director Dr. Sidney Wolfe said in a press release. “By ignoring Public Citizen’s petition for more than a year, the agency has ignored this responsibility and instead has chosen to support the profit interests of a large pharmaceutical company.”

According to Public Citizen, the side effects of Aricept in the 23 mg dose are far more toxic than at lower doses. In addition, there appears to be little clinical benefit from using the higher doses over the lower ones.

High doses of Aricept have been linked to a number of potential health risks, including lowered pulse, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness, agitation, confusion and anorexia, the group claims.

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 some of its own reviewers in 2010.