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Galantamine
hydrobromide (marketed as Razadyne,
formerly Reminyl) Information
FDA ALERT [3/2005]
FDA and other international health authorities
are reviewing the safety of Razadyne after data from two
clinical studies indicated that people taking the drug had a
higher death rate than those taking a placebo (sugar pill).
Based on this information, FDA has asked the manufacturer to
revise the labeling. Please ask your healthcare provider if
Razadyne is right for you.
This information reflects FDA’s preliminary analysis of data
concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information. FDA intends to update this
sheet when additional information or analyses become available.
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Patient Information Sheet [PDF]
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Date created: March, 2005, updated August 9, 2006 |
