Tacrine import alert

Executive Summary

FDA said it is reviewing the status of the alert, which began in December 1988. Sold as a "smart drug," Tacrine is being imported from unapproved sources in the Bahamas and Europe, the agency said. In a Sept. 24 "Talk Paper", FDA said that it has allowed "personal- use" importations of the drug "on a case-by-case basis." Importations have been allowed if assurances are given by a physician that the Alzheimer's patient "will be closely monitored to detect potential serious side effects." FDA prefers that "patients be encouraged to enroll in the Treatment IND".