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FDA Sued for Allowing High-Dose Aricept to Remain on Market

Sep 6, 2012 | Parker Waichman LLP

A public health advocate is suing the Food and Drug Administration (FDA) over a case of what it calls “foot dragging” because the agency will not ban the highest dose of the Alzheimer’s disease drug Aricept.

Public Citizen filed a lawsuit against the FDA this week, saying that the agency has not responded to a petition filed by the group to outlaw the highest dose of the popular drug that’s designed to control symptoms of the debilitating disease that affects millions of Americans and more around the world. The group believes that scientific data shows that Aricept at its highest dose is no more effective in this effort than two lower doses of the drug.

Moreover, the highest dose of Aricept is more likely to put Alzheimer’s patients at risk of serious injury or death. Public Citizen says the highest dose of Aricept can cause fatal vomiting for an Alzheimer’s patient, potentially leading to “pneumonia, massive gastrointestinal bleeding, esophageal rupture, or death,” according to a report from Associated Press, citing the complaint filed in a Washington federal courtroom.

 Public Citizen originally filed its petition in May 2011 and it the latest example of the agency failing to respond to its calls for action. The group routinely petitions the FDA when it believes a pharmaceutical product endangers the lives and health of the public. Often times, the FDA fails to respond to these petitions until its hand is forced by a lawsuit. 

 This particular calls demands the FDA remove the 23-milligram dose of Aricept from the market and to put warning labels on the lower doses (5- and 10-milligrams) to indicate their health risks.

 The lawsuit asks that the court impose a 30-day deadline for the FDA to respond to the petition and believes the longer it balks at acting, the more likely it is that Alzheimer’s patients are being put at risk of suffering severe and potentially life-threatening side effects. The group estimates that as many as 350,000 prescriptions were filled in the last year for the highest dose of Aricept.

 Aricept is only available as a brand-name drug at its 23-milligram dose. The 5- and 10-milligram doses are available in generic form, and at a much lower cost than its counterpart.

 The head of the group said the FDA is ignoring its responsibilities to protect the public’s health and is allowing the makers of Aricept to exploit and harm “vulnerable” Alzheimer’s patients.

 The FDA refused to comment on the lawsuit filed recently but has, in the past, recognized the petition. A spokesperson told AP that the Public Citizen petition requires more research on the agency’s part and that it is still working to investigate the claims.

 Public Citizen believes profits are the motivating factor in keeping the highest dose of Aricept on the market. The application to approve it at the 23-milligram level came just months before the patent exclusivity on the lower doses expired. When a drug company loses the patent on a specific drug, it can expect sales of it to drop significantly as patients often opt for the less expensive generic alternative.

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