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Alzheimer's Drug Given Approval for Higher Dosage Despite Risks to Patients

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Just as their patent was about to expire, the maker of an Alzheimer's drug was given approval for a higher dosage, thereby extending their exclusive right to sell the drug. However, not only will this keep cheaper generic versions from entering the market, the higher dosage also has potentially dangerous side effects for patients.

The drug, Aricept 23, was approved in July 2010 against FDA reviewer warnings about the potential dangers of a higher dosage. The clinical trial of the increased dosage did not show substantial improvements in Alzheimer's patients' cognitive and overall functioning. The single clinical trial looked at 1,400 patients and found that the increased dosage–which went from 5 to 10 mg to 23 mg–led to more nausea and vomiting, which can be seriously dangerous to elderly patients commonly affected by Alzheimer's.

The FDA said that in order for Aricept 23 to be approved the drug maker, Eisai, would have to show that the increased dosage led to both cognitive and overall improvements in Alzheimer's patients. Since the clinical trial showed only insignificant changes in these areas when the dosage was increased, FDA reviewers suggested that the increased dosage not be approved. Nevertheless, the drug was still approved by Dr. Russell Katz, director of the FDA's neurology products division. It is not uncommon for pharmaceutical companies to come up with novel ways of extending patents on drugs to prevent cheaper generic versions from entering the market.