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Executive Summary

Benzodiazepine promotional materials that claim sedation is not a "problem" are not permitted in the absence of well-controlled data in the public domain, FDA's Rx Advertising & Labeling Div. told 27 manufacturers in a July 25 "preventive letter." It "has become practice in the promotion of benzodiazepines to minimize the degree and/or incidence of sedation in an attempt to differentiate these products," Rx Advertising & Labeling Div. Director Lloyd Millstein, PhD, observed. "Until and unless adequate and well-controlled evidence to the contrary is publicly available, we will continue to regard claims such as 'lack of problem sedation' to be violative and actionable." Millstein pointed out that such claims cannot be supported by a lack of adverse reaction reports. "This class of drug; is generally included with other sedative/hypnotic agents and is recognized as having a fairly high incidence of sedation and related side effects," he said. "Since this side effect is expected from these drugs, it is unlikely to be reported" through FDA's adverse drug reaction reporting system. The letter also discussed claims relating to drug speed of action and the extent of "alertness" benzodiazepine patients experience. FDA issued the letter to clarify its policies relating to benzodiazepine promotional claims. "There are few, if any, demonstrated clinically significant differences between the various competing products," Millstein said. "Generally speaking," he noted, "attempts to create differences through promotional tactics based upon documentation or innuendo and not supported by factual and adequate documentation are viewed" by FDA as FD&C Act violations. Discussing onset of action, Millstein said FDA's position is that such terms as " 'rapid' and 'prompt' connote action within minutes and are not applicable to drugs (in general) which require several hours for major pharmacologic" effects. While benzodiazepines "may exhibit some degree of sedation with a fairly rapid onset," for the most part, they belong "in the latter category." Millstein advised the firms: "If any such claims can be adequately supported by well-controlled studies, then we would not object to appropriate statements." * The letter said the agency will take action against claims such as "restores alertness," "when your patients must remain alert," and "maintains alertness. Millstein noted that some promotions have suggested that the drugs "will bring a patient's psychological state from anxiety down to alert attentiveness, but stop short of relaxed wakefulness." While FDA has reviewed "a considerable volume" of information allegedly supporting this type of claim," we remain unpersuaded that any of the behzodiazepines possess the necessary pharmacologic specificity to accomplish such a psychological feat," Millstein declared. "Furthermore, we do not believe it appropriate to ascribe a degree of alertness to patients taking any drug -- both the known pharmacology and approved labeling of which include sedation, dizziness, and unsteadiness as well as a warning against operation of machinery or motor vehicles." The alertness promotions, Millstein explained, were based on a chapter in "Physiological Correlates of Human Behavior" by Gale and Edwards that suggests a " 'flow pattern' of psychological states."

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