The Agency announced today the first approval of a drug (Ycanth [cantharidin]) available for the treatment of molluscum contagiosum, a viral skin infection that is fairly contagious and is spread by direct skin-to-skin contact. It is approved for use for adults and pediatric patients two (2) years of age and older. However, most infections occur in children under 10 years of age.
The drug is to be applied topically, but get this, it has to be applied by a health care provider once every three weeks as needed and only in their practice setting. Usually, topical products are dispensed by a pharmacy for self-administration, so why is this one different? For one thing, oral ingestion can cause serious life threatening or fatal results. On top of that, the product is highly flammable even after drying.
The FDA apparently decided that, for safety reasons and since this product is most often prescribed for pediatric patients, the drug should not be a take-home medication due to the serious nature of potential adverse events and has also concluded that the “keep out of the reach of children” warning was not sufficient to guard against potential misadventures with home use of the product. The full FDA announcement of the approval can be found here.
