Inclusion of a package insert with each individual Today Sponge may more effectively communicate information about Allendale's contraceptive, Pittsburgh Poison Center Director Edward Krenzelok suggested at FDA's Nonprescription Drugs Advisory Committee meeting July 12.

"Rather than there being a single package insert for the container...there needs to be information on each and every sponge that talks about how to use the product properly," the committee member said, noting women tend to carry one package with them at a time. Several other panel members concurred.

Krenzelok's recommendations came during the committee's discussion of various labeling concerns involving the sponge, including the need to convey the length of time the product must be used to ensure effectiveness and the maximum amount of time it should be used.

Labeling proposed by the agency for the female contraceptive product states: "Wait at least 6 hours after the last intercourse before removing sponge. Do not leave sponge in vagina for longer than 30 hours."

Acting chair Louis Cantilena, MD/PhD, Uniformed Services University of the Health Sciences, maintained the statement is not conspicuous enough on the proposed label. "It doesn't jump right out at you that the product needs to be left in place for six hours."

Donald Uden, University of Minnesota College of Pharmacy, added if the sponge is to be left in for six hours after intercourse and not kept in place for more than a total of 30 hours, "effectively you cannot have sexual intercourse from 24 to 30 hours." Uden said that this window of time when a woman cannot have intercourse needs to be stressed on the label.

Other issues discussed during the NDAC meeting involved efficacy statements and HIV/sexually transmitted disease warnings on labeling for the Today Sponge (¹ Also see "Today Sponge Comparative Efficacy Labeling Supported By NDAC" - Pink Sheet, 17 July, 2000.).

However, regarding adverse events, the committee agreed that requiring Allendale to conduct "active" follow-up on reported AEs is unnecessary, since such a system - in which the company would call consumers who had reported adverse events - would unfairly make Allendale undertake activities not required of other OTC marketers.

Today Sponge Length Of Use Labeling Questioned By NDAC

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