FDA Rejects Petition to Ban Pfizer Inc. Alzheimer Pill

The bitter wrangling between the FDA and Public Citizen over the Aricept pill for Alzheimer’s continues. Yesterday, the agency informed the watchdog that its petition seeking a ban on the highest dose was rejected, two months after Public Citizen sued the FDA for not responding to its petition (here is the lawsuit). Public Citizen sought the ban on the 23mg due to high rates of toxicity and also wanted the agency to warn doctors and patients against the 20mg – or combining the 5mg and 10mg pills – for similar reasons. Aricept, which is marketed by Pfizer and Eisai, was approved for patients with moderate to severe Alzheimer’s. As we noted previously, the petition argued that the only clinical trial submitted to the FDA for approval of the 23mg dose compared it to the 10mg dose, but failed to prove the higher dose was more effective. And in three of four tests, there was no significant difference between the doses on a cognitive or functional level.