• 23
  • May
    2011

Consumer Affairs reported last week that Public Citizen petitioned the Food and Drug Administration to remove from the market a drug used to treat moderate to severe cases of Alzheimer's disease.

The drug in question, Donepezil (also known as Aricept), was approved by the FDA back in 1996 and is now alleged to pose the risk of serious side effects and to be lacking in effectiveness.

The drug reportedly comes in doses of 5 to 10 milligrams for mild to moderate cases of Alzheimer's and in doses of 10 to 23 milligrams for those with moderate to severe cases. Sources said Public Citizen specifically petitioned the FDA to remove the 23 milligram dose from the market.

According to Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, "Data show that the 23-mg dose of Donepezil is significantly more toxic than the 10-mg dose. Combined with its lack of improved clinical benefits, this leads to only one conclusion: that the 23-mg dose should be immediately withdrawn from the market."

Sources said the single clinical trial on which the FDA approved the 23-mg dose of Donepezil simply compared it to the 10 mg dose, but failed to prove the higher dose was actually more effective. The majority of the tests performed say there is no significant difference between the 10 mg and the 23 mg dose.

Some medical professionals say that drugs like Aricept have had so much market success because of heavy commercialization which feeds on the desperation of those caring for Alzheimer's patients.

Public Citizen also asked the FDA to advise doctors and patients against taking the 20 mg dose of Donepezil.

Source: Public Citizen, "Dangerous Alzheimer's Drug Should Be Pulled: Public Citizen," 18 May 2011.