The maker of the experimental Alzheimer drug tacrine (THA) won the Food and Drug Administration's okay last week to distribute the still unapproved medication more widely under the FDA's special "expanded-use" program for promising but unproven therapies.
FDA Commissioner David A. Kessler announced on the CBS show "This Morning" that Warner-Lambert Co. may provide THA in a range of escalating dosages to up to 3,000 Alzheimer's patients not enrolled in a controlled clinical trial of the drug. But Kessler cautioned that "it's very important to underline that it's only suggestive that the drug works." He added that while previous trials indicated that THA can slow memory loss among some Alzheimer patients, they also demonstrated the drug's potential for damaging patients' livers.
An FDA advisory committee declined to recommend approval of THA last March, citing the insufficiency of safety and efficacy data (SN: 3/23/91, p. 180).
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