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February 5, 2015
Here’s an important alert for Alzheimer’s disease patients and their caregivers.
On January 21, 2015, Health Canada, the Canadian equivalent of the Food and Drug Administration (FDA), issued a warning concerning two rare but potentially very serious adverse effects of the drug donepezil (ARICEPT, ARICEPT-23).[1]
Donepezil is approved for the treatment of Alzheimer’s disease. Generic versions are available from more than 20 different companies in the U.S.[2] Done...
February 5, 2015
Here’s an important alert for Alzheimer’s disease patients and their caregivers.
On January 21, 2015, Health Canada, the Canadian equivalent of the Food and Drug Administration (FDA), issued a warning concerning two rare but potentially very serious adverse effects of the drug donepezil (ARICEPT, ARICEPT-23).[1]
Donepezil is approved for the treatment of Alzheimer’s disease. Generic versions are available from more than 20 different companies in the U.S.[2] Donepezil is available either alone or, as of December 2014, in combination with memantine, another drug approved for Alzheimer’s disease. The combination is marketed as NAMZARIC by Forest Labs Inc.[3] Donepezil is listed as a Do Not Use drug on WorstPills.org because of its poor efficacy.
The first warning from Health Canada concerned the risk for rhabdomyolysis, a condition that results in the breakdown of muscle. Symptoms include muscle pain, fever, weakness, nausea and dark urine. If untreated, it can lead to kidney failure and abnormal heart rhythms.[4] The risk is increased if the patient is taking other drugs known to cause rhabdomyolysis, such as statins, antipsychotics and certain classes of antidepressants (selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors).[5]
The second warning concerned the risk for neuroleptic malignant syndrome (NMS). Symptoms of NMS include fever, mental changes, agitation, delirium and muscle rigidity (which, in turn, can lead to rhabdomyolysis).
Health Canada found a total of 88 cases of rhabdomyolysis (three fatal) and 67 cases of NMS (nine fatal) internationally that had been reported to the brand-name manufacturer. In most cases, patients had one or the other of these conditions, but some suffered both. The FDA has not yet issued any similar warnings concerning these two serious adverse events.
What you can do
If you or a loved one is taking donepezil, contact your or your loved one’s health care provider to discuss stopping the drug. Do not stop this or any drug without consulting your health care provider. If you notice any of the symptoms of rhabdomyolysis or NMS listed above while still taking donepezil, seek medical attention immediately.
Be sure to report serious adverse events while taking drugs to the FDA’s MedWatch Adverse Event reporting program at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or by calling 800-FDA-1088.
References
[1] Health Canada. Summary safety review — Aricept (donepezil) — risk of rhabdomyolysis and neuroleptic malignant syndrome. January 21, 2015. http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/aricept-eng.php. Accessed February 5, 2015.
[2] Food and Drug Administration. Orange book: Approved drug products with therapeutic equivalence evaluations. Updated December 2014. http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm. Accessed February 5, 2015.
[3] Food and Drug Administration. Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed February 5, 2015.
[4] Health Canada. Summary safety review — Aricept (donepezil) — risk of rhabdomyolysis and neuroleptic malignant syndrome. January 21, 2015. http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/aricept-eng.php. Accessed February 5, 2015.
[5] Health Canada. Alzheimer's drug Aricept (donepezil) - New warnings on the serious risks of muscle breakdown and of a neurological disorder. January 21, 2015. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/43469a-eng.php. Accessed February 5, 2015.
