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U.S. Department of Health and Human Services

Drugs

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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.

Other Information

 

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page. 

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857
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