|The FDA's Reply to the Sponge Petition Was Inadequate|
|In responding the Citizen Petition on the Safety of the Today Sponge, the FDA cited a small study which suggested that another OTC vaginal contraceptive (Conceptrol (Ortho Pharmaceuticals)) was shown to be slightly more irritating than the Sponge. Although such a fact offers little comfort to young women victimized by either product, among the major shortcomings of this industry sponsored study was the statement by the authors that they did not know if the 42 subjects actually used any of the contraceptive products as requested (click for details on this reference), undermining the credibility of any comparison on the matter of irritation.
The other major point in the FDA Reply was a repetition of the claim that only 125 mg of N-9 is released from a Sponge when its in the vagina for 24 hours. The only data on this topic was derived from a small study which was done in with a prototype for the Today Sponge, The 2-Day Sponge, which was worn for 48 hours. (See Note below) The FDA Reply reports additional data from that study on 54 users, which showed that more than 20% of the users were exposed to 300 to 500 mg of N-9. As pointed out later in the Reply, the new FDA standard for N-9 will state that using any of the OTC Contraceptives more than once a day will expose a woman to a dose of N-9 that may cause harm. (click here to see text). If we accept the suggestion that data from this study applies to the Today Sponge, we can conclude it is the only contraceptive product, that under normal daily use, will expose many women to an unsafe dose of N-9.
To summarize the inadequacies of the FDA Reply:
1. There is no credible evidence that any other OTC contraceptive is as irritating as the Today Sponge;
2. The very limited clinical data on the amount of N-9 released from the Sponge, which has been questioned by an FDA Medical Officer, do not support that this product releases N-9 in a dose that is comparable to other OTC contraceptives.
3. With 1000 mg of N-9 in each Sponge, which may be left in the vagina for up to 30 hours, this product will frequently expose women to amounts of N-9 higher than the FDA recommends in its new labels for OTC contraceptives.
We recommend that women avoid using the Today Sponge because this high dose product can frequently cause vaginal irritation and infections, and, as noted on the new package, increase the risk of an HIV infection.
We will continue to call on the FDA to apply their safety standards for N-9 rigorously to the Today Sponge. The Women of America deserve that protection from the FDA.
For a complete copy of the
|Note: Why is the FDA using such limited data - collected over 20 years ago, with a product used for 48 hours - to justify the sale of the Today Sponge in 2005?
Please contact the FDA and ask: The author of the Reply was,
Dr. Steven Galson,
Center for Drug Evaluation & Reseach,
Rockville, MD 20857