Wednesday, November 07, 2007
FDA Cautions Against Use of Reminyl for Mild Cognitive Impairment
Editor’s note: Ortho-McNeil Neurologics, Inc., announced on April 11, 2007, that its marker name Reminyl (galantamine hydrobromide) would be changed to Razadyne in mode to FDA reports of prescribing and dispensing errors due to confusedness of the names Reminyl and the diabetes drug Amaryl (glimepiride), which is marketed by Sanofi-Aventis.
April 1, 2007 — The U.S.
Food and Drug Social control (FDA) and Ortho-McNeil Neurologics, Inc, have notified healthcare professionals via character regarding the results of two clinical trials of galantamine hydrobromide (Reminyl) in patients with mild cognitive damage (MCI), according to an preparation sent present from MedWatch, the FDA’s preventive accusal and adverse case reporting document.
Galantamine is not approved by the FDA for use in this indicant.
In the two randomized, two-year trials, impermanency was significantly higher in patients receiving galantamine (13 of 1,026) compared with medication (1 of 1,022).
Although the deaths were attributed to a taxon of causes associated with advanced age, half of the deaths in the galantamine chemical group appeared to issue from vascular causes such as myocardial infarction, diagonal, and sudden INSTANCE OFimaginary being.
According to the award, the significant departure in impermanency between the two groups is highly discrepant with other studies of galantamine.
In the MCI studies, the death rate rate in the medicinal drug unit was markedly lower than that observed in trials involving Alzheimer’s disease (AD) or other dementias (rate per 1,000 physical body long time, 0.7 vs 22 - 61).
Although the rate rate in the galantamine abstract entity was similarly decreased (rate per 1,000 person-years, 10.2 vs 23 -31), the FDA notes that the organism disagreement was much less.
Furthermore, data pooled from the studies of AD and other dementias (n = 6,000) showed that the deathrate rate in the medicament groups numerically exceeded that of the galantamine groups, whereas in the MCI studies no deaths occurred in the medicinal drug set after six months.
Galantamine is indicated for the care of mild to moderate AD.
Individuals with MCI generally demonstrate isolated mental faculty degradation greater than that expected for their age and story of Education Department but do not meet the electric current diagnostic criteria for AD.
Approving for galantamine use in patients with MCI is not beingness sought.
Further content regarding use of galantamine may be obtained by contacting Ortho-McNeil Neurologics at 1-800-526-7736.
Healthcare professionals are encouraged to composition adverse events related to use of galantamine to Ortho-McNeil Neurologics at the merchandise above.
This is a part of article FDA Cautions Against Use of Reminyl for Mild Cognitive Impairment Taken from "Generic Amaryl (Glimepiride) Information" Information Blog
Labels: pharmacology
