Study examines storing, using reconstituted botulinum toxin A
Storing vials of reconstituted botulinum toxin A (Botox, Allergan) for four weeks after patient administration results in no detectable bacterial or fungal contamination, according to a new pilot study.
“Although findings of several studies indicated that reconstituted botulinum toxin A (BTX-A) retained efficacy during storage for several weeks, there was insufficient evidence that sterility was maintained for this duration. Regardless of potency, contamination remained a concern for physicians who treat patients with reconstituted BTX-A after the recommended period by the manufacturer,” the study’s lead author Teissy Osaki, M.D., and Ph.D. candidate at the division of ophthalmic plastic and reconstructive surgery, Federal University of São Paulo, São Paulo, Brazil, tells Cosmetic Surgery Times.
Dr. Osaki and colleagues evaluated the contents of 88 reconstituted vials of BTX-A after clinical administration of an aliquot and subsequent storage of the remaining contents under refrigeration for four weeks.
Research suggests the practice of storing and using reconstituted BTX-A is somewhat common.
“…an online survey of BTX-A utilization among members of the American Society for Dermatologic Surgery indicated that most physicians (68.6%) routinely store BTX-A for a longer period (more than one week after reconstitution) than the 24-hour period recommended by the manufacturer,” Dr. Osaki says.
But this study by no means supports the practice. The authors of the study do not recommend utilizing reconstituted BTX-A beyond the period indicated by the manufacturer, according to Dr. Osaki.
“Our study was a pilot study…,” Dr. Osaki says. “Future multicentric studies that evaluate a larger number of vials and other possible contaminants are needed, and the results of these additional future studies may support the storage of reconstituted BTX-A for longer than the period recommended by the manufacturer.”
Note: There were some errors in the published version and an erratum will be published in the next edition of Aesthetic Surgery Journal, according to Dr. Osaki.
Osaki T, Osaki MH, Osaki TH, Sant'Anna AE, Yu MC, Hofling-Lima AL. Absence of bacterial or fungal growth in vials of reconstituted botulinum toxin type A after storage. Aesthet Surg J. 2015 Feb;35(2):189-93. http://www.ncbi.nlm.nih.gov/pubmed/25717119