Trial Deaths Prompt Ortho-McNeil to Modify Precautions on Reminyl

Ortho-McNeil Neurologics has updated prescribing information on its Alzheimer's drug Reminyl to disclose recent deaths among patients participating in two clinical trials of the drug, according to an FDA MedWatch report.

The labeling modifications stem from two randomized, placebo-controlled trials of two years in duration in subjects with mild cognitive impairment (MCI). In the trials, a total of 13 subjects on Reminyl (galantamine hydrobromide) and one subject on placebo died, according to a March 31 Dear Healthcare Professional letter from Ortho-McNeil Neurologics, unit of Johnson & Johnson.

The deaths resulted from various causes, all of which could be expected in an elderly population, the letter said. Roughly half of the Reminyl deaths appeared to result from various vascular causes, including myocardial infarction, stroke and sudden death.

"Although the difference in mortality between Reminyl and placebo-treated groups in these two studies was significant, the results are highly discrepant with other studies of Reminyl," the letter states.

When Alzheimer's disease and other dementia studies were pooled, the mortality rate in the placebo group numerically exceeded that in the Reminyl group, the letter said. "Furthermore, in the MCI studies, no subjects in the placebo group died after 6 months, a highly unexpected finding in this population," the letter said. The firm also noted it is not seeking an indication for the treatment of individuals with MCI.

Ortho-McNeil's letter on Reminyl is available at http://www.fda.gov/medwatch/SAFETY/2005/reminylDDLmarch.pdf (http://www.fda.gov/medwatch/SAFETY/2005/reminylDDLmarch.pdf).