Group Sues FDA Over ‘Dangerous Dosage’ of Alzheimer’s Drug

by Angela Nazworth | September 7, 2012 12:06 pm

Public Citizen is suing the Food & Drug Administration (FDA) over the drug Aricept, which is used to treat Alzheimer’s disease. The consumer advocacy group wants the FDA to stop allowing the drug to be marketed at doses that Public Citizen says can cause severe – and even fatal – side effects.

According to Public Citizen, a 2009 study submitted to the FDA has shown that the 23-mg version of the drug was associated with a much higher incidence of vomiting, which in patients with Alzheimer’s disease “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death,” according to the FDA’s own guidelines,

That same study failed to show that high doses were more effective than lower doses.

The suit follows a May 2011 petition from Public Citizen urging the FDA to immediately remove from the market a 23-mg dose of Aricept and to add to lower-dosage (5 mg and 10 mg) forms of the drug and its the generic counterpart, donepezil. According Public Citizen, the FDA never responded to the petition.

“A primary function of the FDA is to protect citizens from harm caused by needlessly dangerous drugs, in this case a drug no more effective but significantly more dangerous than the lower doses of Aricept,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a press release. “By ignoring Public Citizen’s petition for more than a year, the agency has ignored this responsibility and instead has chosen to support the profit interests of a large pharmaceutical company.”

Wolfe said during the past year, approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23, with total sales of $91 million.

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