Botox under the microscope: But Allergan is unscathed for now in FDA review

May 1, 2008

A Food and Drug Administration (FDA) review of the safety of botulinum toxin injections hasn't significantly impacted sales of the neurotoxin to date, doctors and analysts say.

Key Points

Any slowdown in bookings for cosmetic treatments probably stems from economic conditions and perhaps competition, not safety concerns, they say.

"I've been amazed. I thought this was going to have a significant negative impact" on Botox sales, says Lawrence S. Reed, M.D., a board-certified plastic surgeon and assistant professor of surgery at New York Presbyterian Hospital.

The adverse reactions appear related to the spread of the toxin beyond the injection site and mimic symptoms of botulism, the release states.

Officials of Solstice Neurosciences did not respond to multiple requests for comment.

At press time, the FDA continued to evaluate data collected from manufacturer-submitted clinical studies, post-marketing adverse event reports and medical literature, according to Sandy Walsh, FDA public affairs specialist.