Skin Exposure Paste
"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle â€“ every drug that FDA approves â€“ carries some risk. One of the first lines of defense against "...
Skin Exposure Paste
(Generic versions may still be available.)
The handling of smoking products, such as cigarettes, by personnel who have even small amounts of SERPACWA on their hands may result in contamination of these products with SERPACWA. Smoking of products contaminated with the PTFE component of SERPACWA generates harmful fumes. A flu-like syndrome called polymer fume fever has been reported in individuals who have been exposed to fumes generated by the burning of PTFE, such as fumes generated by the smoking of cigarettes contaminated with PTFE powder. The severity of this syndrome depends upon the amount of exposure and the number of exposures. Polymer fume fever should not be regarded as a transitory or benign condition. The long-term health significance of smoking products contaminated with PTFE has not been characterized. While patients with mild manifestations of this syndrome appear to have self-limited symptoms without lasting effects, a patient with a more severe manifestation of this syndrome developed interstitial pulmonary fibrosis. The risk associated with smoking products contaminated with SERPACWA has not been characterized. Because the paste-like consistency of SERPACWA could possibly enable it to adhere more efficiently to smoking products than does PTFE powder, the risk of polymer fume fever, and its degree of severity, may be higher following SERPACWA exposure to smoking products than the historical risk associated with handling of cigarettes by personnel exposed to PTFE powder exposure.
Personnel should not touch smoking products after they have applied SERPACWA to their skin surface. Personnel are advised to wash their hands thoroughly to remove all visible traces of SERPACWA prior to handling smoking products. Smoking products may become contaminated even if there are no visible traces of SERPACWA on the hands. Some, but not all individuals with polymer fume fever reported that the tobacco smoke had an unusual or unpleasant taste.
If the smoke has an unusual taste, this may be indicative of product contamination. Under these circumstances, personnel should cease smoking and discard the potentially-contaminated products. Even in the absence of an unusual or unpleasant taste, the smoking product may still be contaminated, so smoking should be avoided after use of SERPACWA. Clothing or other materials exposed to SERPACWA, including SERPACWA packaging, should not be destroyed by burning, because of the release of toxic fumes.
In animal studies, the presence of insect repellent containing DEET (N,N-diethyl-m-toluamide) has been demonstrated to significantly reduce the barrier effects of SERPACWA. The use of water to remove products containing DEET reduces the barrier effect of SERPACWA, while removal of insect repellent with dry gauze partially restores a barrier effect for SERPACWA. Though the relevance of the results of these animal studies to humans is unknown, it is recommended that products containing DEET be removed with a dry towel or cloth before SERPACWA is applied.
EFFECT OF DEET PRODUCT AND PRODUCT REMOVAL METHODS ON SERPACWA
EFFICACY WHEN CHALLENGED WITH HD
|Pretreatment Agents||N||Test Conditions||Product Removal Method||Lesion Area Ratio (%)|
| Arithmetic Mean
| Geometric Mean
|SERPACWA||32||-||27 (11, 43)||26 (15, 46)|
|DEET PRODUCT + SERPACWA||32||A||None||91 (16, 166)||82 (41, 166)|
|DEET PRODUCT + SERPACWA||8||B||None||92 (70, 114)||77 (59, 102)|
|DEET PRODUCT + SERPACWA||8||C||moist towelette||122 (85, 158)||97 (72, 132)|
|DEET PRODUCT + SERPACWA||8||C||dry gauze||48 (32, 64)||39 (29, 52)|
- DEET product was applied 3 hours prior to SERPACWA applications.
- DEET product was applied approximately 12 minutes prior to SERPACWA applications.
- DEET product was applied for 3 hours then removed just prior to SERPACWA applications by either a moist towelette (alcohol-free, dilute soap solution) or a dry gauze pad.
Some camouflage paints (loam and sand) and possibly permethrin also reduced the protective effects of SERPACWA.
Studies in humans were not conducted with CW or surrogate agents using SERPACWA in the presence of insect repellents containing DEET, or loam and sand camouflage paints, or permethrin. It is not known whether DEET affects the barrier properties of SERPACWA or whether it is the other ingredients in this product.
Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Skin Exposure Paste Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.