High Dose Aricept Should Go, Public Citizen Says

Both advocacy group Public Citizen and a Johns Hopkins University geriatric specialist are calling for an end to high-dose <"http://www.yourlawyer.com/topics/overview/aricept">Aricept, the popular Alzheimer’s disease medication. It seems, said Public Citizen and Dr. Thomas Finucane, the ban should be put in place as not only is there no increased efficacy from the high, versus the low, dose, the high dose has been linked with significant risks for adverse effects, wrote the LA Times, citing a petition to the U.S. Food and Drug Administration (FDA).

Aricept (generic: donepezil) 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, notes the LA Times. 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.

Aricept is an anticholinergic drug, which works by stopping acetylcholine—a chemical that enhances communication between nerve cells in the brain—from binding to its receptors in nerve cells. The drug is FDA approved in two doses, said the LA Times: 5 to 10 milligrams for mild to moderate cases of Alzheimer’s and 10 to 23 milligrams severe cases Alzheimer’s disease patients. The petition seeks an FDA ban of the 23-mg version and a warning to patients and physicians against taking two 10-mg pills to compensate if the higher dosage version is banned, said the LA Times.

No meaningful benefit was realized in the 23-mg version versus the 10-mg version, according to clinical trials sent to the FDA; however, increased side effects from the higher dosage involved “slowed pulse rate, nausea, vomiting, diarrhea, urinary incontinence, fatigue, dizziness, agitation, confusion and anorexia,” said the LA Times. Also, vomiting was reported more than 3.5 times in patients taking the higher dosage. Of note, said the LA Times, vomiting is a significantly dangerous response in those suffering from Alzheimer’s disease, citing the petition, which explained that vomiting can “lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture, and … death,” in these patients.

“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, quoted the LA Times. “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,” Dr. Wolfe added.

We previously wrote that two reports written by Wake Forest University School of Medicine researchers supported findings concerning anticholinergic medications like Aricept stating these drugs may adversely affect the thinking skills of older patients, a phenomenon not observed in patients studied who did not take these medications. The studies also indicated that anticholinergics may cause older patients to experience a decrease in their daily physical activities.

We also have written that the FDA was looking into the results of a study of Aricept that involved 974 patients suffering from dementia. Eleven patients died versus no deaths among those taking the placebo. Medical experts say the study might indicate that Aricept and similar drugs increase the risks of heart disease, said The New York Times previously. Another study concluded that Aricept does not delay the onset of disability or the need for nursing-home care for Alzheimer’s patients and that the drug provided little overall benefit and was expensive.

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