The deaths of 13 elderly patients taking the prescription drug Reminyl (galantamine hydrobromide) for treatment of symptoms related to Alzheimer’s disease have prompted a change to the precautions section of the drug’s labeling. Reminyl is approved for the treatment of mild-to-moderate Alzheimer’s disease. Two clinical trials were conducted to research the use of Reminyl for mild cognitive impairment in which one group of patients received Reminyl and one group received a placebo. There were 13 deaths in the group of patients receiving Reminyl compared to one in the placebo group.

Ortho-McNeil issued a “Dear Healthcare Professional” letter on April 5, 2005, warning that information about the deaths in the studies will be added to the section of the drug’s labeling called “Precautions.” In addition, the company has changed the drug’s brand name to Razadyne to avoid confusion of the drug with the diabetes drug Amaryl. The U.S. Food and Drug Administration has received several reports of prescribing and dispensing errors between Reminyl and Amaryl. Approximately 2 million patients have been treated with Reminyl since its introduction.

Source: Daniel DeNoon, “Reminyl Deaths Prompt Warning,” Webmd.com, April 5, 2005.