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December 4, 2014
Here’s an important alert for Alzheimer’s disease patients and their caregivers:
On November 18, 2014, Health Canada[1] (the equivalent of the Food and Drug Administration [FDA] in the U.S.) issued new safety information warning that the Alzheimer’s disease drug galantamine (RAZADYNE, RAZADYNE ER) has been associated with rare but serious, potentially fatal skin reactions.
These skin reactions may include:
- Severe rash with blisters and peeling skin, particularly around...
December 4, 2014
Here’s an important alert for Alzheimer’s disease patients and their caregivers:
On November 18, 2014, Health Canada[1] (the equivalent of the Food and Drug Administration [FDA] in the U.S.) issued new safety information warning that the Alzheimer’s disease drug galantamine (RAZADYNE, RAZADYNE ER) has been associated with rare but serious, potentially fatal skin reactions.
These skin reactions may include:
- Severe rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals.
- Red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever.
- Rash that may blister with spots that look like small targets.[2]
The most dangerous of these reactions is the blistering rash with peeling skin, which may represent Stevens-Johnson syndrome, a medical emergency that is similar to experiencing severe burns and usually requires hospitalization.
If you, or someone for whom you are caring, experience any of the above symptoms while taking galantamine, you should call your health care provider immediately to discuss stopping the drug.
Public Citizen’s Health Research Group previously has designated galantamine as Do Not Use because it is minimally effective and has been linked to gastrointestinal and cardiovascular side effects.[3] Learn more about the safety and efficacy of this drug at WorstPills.org.
The FDA has not yet provided similar warnings to health care providers in the U.S. It is important to alert the FDA of this problem by reporting symptoms to the MedWatch Adverse Event reporting program, either online (at https://www.accessdata.fda.gov/scripts/medwatch/) or by phone at 888-INFO-FDA (888-463-6332).
References
[1] Healthy Canadians. REMINYL ER (galantamine hydrobromide) - New Safety Information Regarding the Risk of Serious Skin Reactions - For the Public. November 18, 2014. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/42237a-eng.php. Accessed December 1, 2014.
[2] Healthy Canadians. REMINYL ER (galantamine hydrobromide) - New Safety Information Regarding the Risk of Serious Skin Reactions - For the Public. November 18, 2014. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/42237a-eng.php. Accessed December 1, 2014.
[3] WorstPills.org. Drug profile — galantamine. https://www.worstpills.org/monographs/view/129. Accessed December 1, 2014.
