The Food and Drug Administration (FDA) agreed to let Pfizer sell a higher dosage of a best-selling Alzheimer’s drug as a means of extending its patent, even though the new prescription dose caused potentially harmful side effects.

 

Developed by the Japanese firm Eisai and marketed in the U.S. by Pfizer, the drug, Aricept, was due to lose its patent-protected status in November 2010. Pfizer applied to the FDA to sell the medication in 23 milligram dosages, after spending years providing it in 5 mg and 10 mg amounts. By upping the approved amount, Pfizer bought itself another three years of exclusivity, before other pharmaceutical companies could sell generic versions of Aricept. The FDA gave its approval in July 2010.

 

But a clinical trial of the 23 mg dosage found patients were likely to endure considerably more nausea and vomiting, which can be dangerous for elderly patients dealing with advanced Alzheimer’s.

 

Eisai and Pfizer have earned more than $2 billion from selling Aricept since the FDA first approved it in 1996.

-Noel Brinkerhoff

 

Drug Dosage Was Approved Despite Warning (by Katie Thomas, New York Times)