High Dose Aricept Should be Banned, Public Citizen Lawsuit Charges

A new lawsuit filed by Public Citizen calls for a ban on high dose Aricept (donepezil). As we’ve written, the ban has been called for in light of findings that high does do not provide increased efficacy versus the low dose. Also, the high dose of Aricept has been linked with significant risks for adverse effects.

Aricept is an anticholinergic drug, which works by stopping acetylcholine, a chemical that enhances communication between the brain’s nerve cells, from binding to its nerve cells receptors. The drug approved by the U.S. Food & Drug Administration (FDA) in two doses 5 to 10 milligrams for mild to moderate cases of Alzheimer’s and 10 to 23 milligrams for severe cases. The ban seeks to stop sales of the 23-mg version and to include a warning to patients and physicians against taking two 10-mg pills to compensate if the higher dosage version is banned. Donepezil is available under the brand name Aricept and under a generic made by Japan’s Eisai Co. Ltd.

“The Food and Drug Administration (FDA) has dragged its feet for too long on a petition calling on the agency to stop allowing the drug Aricept to be marketed at doses that can cause severe—and even fatal—side effects,” Public Citizen said in its lawsuit. In fact, said The Associated Press (AP), Public Citizen said that the FDA’s medical and statistical reviewers discovered that high-dose Aricept is not any better at controlling moderate-to-severe Alzheimer disease symptoms versus two low doses. Public Citizen filed the petition with the FDA in May 2011

According to Public Citizen, high dose Aricept has been linked with more dangerously fatal reactions, such as vomiting—no small side effect in Alzheimer’s patients in which vomiting “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture, or death.” Other side effects include nausea, diarrhea, anorexia, and confusion, said the AP.

The lawsuit was filed in federal court in Washington and asks the court to declare the FDA’s inaction unlawful and to order the agency to decide—within 30 days of the court’s ruling—if it should or should not approve Public Citizen’s request. The lawsuit, said the AP, seeks legal fees and other reasonable costs. “By ignoring Public Citizen’s petition for more than a year, the agency has ignored (its) responsibility,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said. “During the past year alone approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23,” Dr. Wolfe added, saying “Allowing Eisai to exploit and harm vulnerable patients with Alzheimer’s disease is unconscionable.”

As we’ve explained Aricept is one of just a few medications available for the treatment of Alzheimer’s disease. Sadly, Aricept, provides very moderate slowing of the cognitive and functional problems linked to the debilitating disease. The drug is popular “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. Finucane, quoted the LA Times previously.

FDA spokeswoman, associate policy director in its Center for Drug Evaluation and Research, Jane Axelrad, said the agency does not comment on pending litigation. “FDA has been unable to reach a decision on your petition because it raises significant issues requiring extensive review and analysis by agency officials,” Axelrad wrote. “We will respond to your petition as soon as we have reached a decision on your request,” she added, said the AP. Marcia Diljak, a spokeswoman at Eisai’s U.S. subsidiary, Eisai Inc., said the firm knew about the complaint, but would not comment. “We stand by the FDA’s decision” to approve high-dose Aricept for the treatment of Alzheimer’s disease, Diljak, wrote in an email.