Public Citizen sues FDA over Aricept safety

Public Citizen has stepped up its fight against high-dose Aricept. The consumer advocacy group, which demanded last year that FDA pull the Eisai drug's 23 mg dose, sued the agency yesterday for action.

The lawsuit reiterates Public Citizen's claims about the Alzheimer's treatment--that Eisai's own data show that the higher dose isn't more effective at treating moderate to severe Alzheimer's. What it does offer, Public Citizen says, is a greater risk of side effects such as nausea, vomiting and gastric bleeding.

"Although the study failed to show that the 23 mg dose has any clinically meaningful benefit, the study demonstrated that, in comparison with the 10 mg dose, the use of a 23 milligram dose ... is associated with a significant risk to patient safety," the lawsuit claims (as quoted by Bloomberg).

As the news service points out, the 23 mg dose of Aricept won FDA approval in 2010, just as the 10 mg dose neared patent expiration. With 38% of its 2010 sales coming from Aricept, Eisai had every incentive to promote the newer dose. For the first half of its fiscal 2011, the first full period after generic rivals hit the market, Eisai's profits dropped by 17%, as Aricept revenues plummeted by more than half.

FDA wouldn't comment on the lawsuit, and nor would Pfizer ($PFE), which is Eisai's U.S. marketing partner. Eisai itself said it stands by its 23 mg Aricept product as a "safe and effective treatment of moderate to severe Alzheimer's disease."

- read the Bloomberg story