Last January, Johnson & Johnson announced that the FDA was reviewing safety data on galantamine hydrobromide (Reminyl®), a cholinesterase inhibitor that has been approved for mild to moderate Alzheimer disease (see ARF related news story). Now, that reappraisal has resulted in a voluntary relabeling of the prescription drug (see WedMD article).
The initial review and the new labeling arose from an unexpected number of deaths reported in clinical trial data. In January 2005, Johnson & Johnson reported preliminary results from two pivotal studies of approximately 2,000 patients (The GAL-INT-11 and GAL-INT-18 trials), in which 15 people taking Reminyl died, compared to only five deaths in the placebo group (see Johnson &Johnson statement).
In a March 31 letter to healthcare professionals, Ortho-McNeil Neurologics Inc., a Johnson & Johnson subsidiary, report that the drug label will now carry a precautionary note. This reflects a more thorough evaluation of the trial data. In fact, only 13 patients on Reminyl died during these trials, but there was only one death in the placebo groups. Though this discrepancy seems cause for concern, it should be noted that the number of deaths in the placebo groups was lower than expected. In addition, the numbers are probably not large enough to draw any firm conclusions about safety (see comment from AD clinician John Morris in ARF related news story) on this issue.
Reminyl has also been renamed to avoid confusion with the similarly sounding Amaryl,® which is used to treat diabetes. Galantamine will now be marketed as Razadyne™ (see statement on FDA website).—Tom Fagan.
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