Healthcare giant, Johnson & Johnson, says that it has updated the prescribing information for its Alzheimer’s disease drug, Reminyl (galantamine), after 13 people died whilst taking the drug in a clinical trial assessing its potential use in mild cognitive impairment.
In a Dear Doctor letter published on the US Food and Drug Administration’s website late last week, J&J explained that the two two-year trials included over 2,000 patients with mild cognitive impairment, and noted that one patient from the placebo group also died during the trials. However, it adds that the deaths were due to various causes, which could be expected in an elderly population. About half of the Reminly deaths appeared to result from various vascular causes, including heart attack, stroke, and sudden death.
J&J says that it is not seeking to market Reminyl in the treatment of mild cognitive impairment.