Put this Alzheimer’s drug at the top of the list titled “More Harm than Good”

One thousand and 23

No. One thousand times… NO!

Without hesitation, that was my response when a friend asked me about Aricept 23.

She knew that her father’s Alzheimer’s symptoms had been worsening. His doctors recommended Aricept 23. It would likely improve his mental function, they said. Predictably, they played down side effects. They described them as “rare,” of course.

Had I heard of this drug?

Unfortunately, yes. And I wish I never had. But here, at least, was a chance to warn someone before it was too late.

Shady scheme

The deal with Aricept 23 is a bad deal all around.

It’s a familiar story. A drug is about to lose patent. Drug makers hatch a scheme to extend patent protection. FDA officials get out the rubber stamp that says, “YES!”

Everybody goes home happy. Well… Everyone except AD patients and their caregivers.

In this case, Aricept (made by Eisai) was about to lose its patent. It was available in two doses — 5 mg and 10mg. So Eisai executives had a brainstorm. They created a 23 mg Aricept.

Yes! A super potent Aricept! More than TWICE as good as a paltry 10 mg!

Sure. In their dreams. Now for the dirty details…

Eisai tested Aricept 23 against the 10 mg dose of the drug. Super? Not quite. It barely performed any better than the lower dose. But the higher dose considerably increased risk of dangers.

Patients who took Aricept 23 were far more likely to be agitated, confused and fatigued. They were also more than three times more likely to experience vomiting. In Alzheimer’s patients, that can prompt a cascade of agonizing events. They include, in the FDA’s own description, “…pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.”

Add to that, the drug lingers in a patient’s system. If vomiting occurs and the patient stops using the drug, vomiting risk remains high for as much as two weeks!

The agency’s primary medical reviewer said the drug should not be approved. So… The FDA approved it.

Agency officials probably hoped that approval would make the scrutiny go away. The drug would get three years of patent protection. Over and out. Simple.

Not quite.

Public Citizen petitioned the FDA to remove Aricept 23 from market. The FDA ignored the petition. Well over a year later (after more than $90 million in sales), Public Citizen filed a lawsuit to force a decision from the FDA.

Finally, the FDA responded with a simple, “No.”

I don’t think anyone expected the agency to do the right thing. So we’ve got to appreciate Public Citizen’s efforts. They’ve kept the horrendous dangers of Aricept 23 on the national radar.

Alzheimer’s caregivers must beware of this drug. It’s intended for patients with moderate to severe AD. But these are the very patients who are most vulnerable to side effects.

Just say what the FDA said. “No.”

Sources:
“FDA rejects petition to remove high Aricept dose” Associated Press, 11/6/12, ap.org

“Public Citizen v. Food and Drug Administration (Aricept 23 mg)” Public Citizen, 9/5/12, citizen.org

“How the FDA forgot the evidence: the case of donepezil 23 mg” Lisa M. Schwartz, Steven Woloshin, British Medical Journal, Vol. 344, 3/22/12, bmj.com

“New Alzheimer’s pill more likely to cause misery, medical experts say” Melissa Healy, Los Angeles Times, 3/22/12, latimes.com