Off-label prescribing of Alzheimer’s drug could be risky

Created date

May 10th, 2017
Close-up view of a doctor writing a prescription

A study by University of California Los Angeles (UCLA) School of Nursing researchers has found that donepezil, marketed under the brand name Aricept, should be prescribed with caution in people with mild cognitive impairment (MCI).

Donepezil is approved by the Food and Drug Administration (FDA) for people diagnosed with Alzheimer’s disease, but although it has been studied in the past for people with MCI, it is not FDA-approved as safe or effective for people with this disorder, which is sometimes, but not always, a precursor of a dementia-related illness such as Alzheimer’s disease. People with MCI can have similar symptoms as people with Alzheimer’s, so some health care providers prescribe donepezil for the condition. Because donepezil is not FDA-approved for MCI, this is called off-label prescribing.

Possible negative impact in some

In the new study, the UCLA researchers found that people with a certain gene variation (mutation) called BChE-K who are prescribed donepezil for MCI may experience a worsening of their cognitive decline.

Prescribing medicine based on someone’s genetic profile is called personalized medicine or precision medicine. This practice is becoming increasingly popular as research yields more findings. The UCLA study findings reinforce the importance of physicians discussing the risks and benefits of prescribing medicine based on genes.