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April 28, 2005
FDA Reply to Today Sponge Safety Questions Called Inadequate
The frequent irritation and increased risk of HIV infection that are associated with the use of the Today Contraceptive Sponge have not been adequately addressed by the 4/22/05 reply from the US FDA.
(PRWEB) April 27, 2005 -- The FDA's reply* to a petition about the safety of the Today Contraceptive Sponge did not adequately answer why the Sponge should again be sold. The Citizen’s Petition**, submitted by two public interest groups** *in April, 2000, describes the frequent irritation and disruptions of the vagina that can be expected by users of the Today Sponge. In addition to the immediate discomfort the Sponge may cause, the prolonged exposure of vaginal tissues to the high concentration of Nonoxynol 9 (N-9) in the Sponge can increase the risk of HIV infection.
In responding the concerns about irritation caused by the Today Sponge, the FDA cited a small study which suggested that another OTC vaginal contraceptive (Conceptrol (Ortho Pharmaceuticals)) was shown to be more irritating than the Sponge. Although such a reply offers little comfort to young women victimized by either product, among the major shortcomings of this industry sponsored study was the acknowledgement by the authors that they did not know if the 42 subjects actually used any of the contraceptive products as requested (1), undermining the credibility of any comparison on the matter of irritation.
When the Today Sponge was first released in 1983, an earlier Petition raised concern about a possible increase in the risk of TSS associated with the Today Sponge. Researchers at the FDA eventually demonstrated that risk and package warnings were added. In response to the concerns in the recent Petition about the increased risk of HIV infection associated with repeated use of the Today Sponge and other high dose vaginal products containing N-9, the FDA announced that new package labels would warn of HIV risk associated with the use of the Sponge.
Dr. Armand Lione, President of Associated Pharmacologists & Toxicologists, the chief author of the Sponge Petition, commented: “We are pleased that the FDA has improved the warnings given to women, but we don’t think that a contraceptive like the Today Sponge, that has a high failure rate and readily produces irritation, is what should be offered to the young people who need these products.”
* For more information on the FDA 4/22/05 reply, please contact: S. Galson, CEDER, at the US Food & Drug Administration.
** A copy of the 2000 petition is available on the FDA website (www.fda.gov)
*** The Empire State Consumer Association, Rochester NY 585-383-1317 co-authored the 2000 Citizen Petition.
(1) Poindexter et al: Contraception 53:147-153, 1996 see p. 148.
Posted by Industrial-Manufacturing at April 28, 2005 01:32 AM