The Food and Drug Administration said Friday that it will review the safety of Irvine-based Allergan Inc.’s Botox and a competitive product after reports of deaths and serious reactions in some patients.
The news sent Allergan shares down 5% on Friday with a market value of about $19.6 billion.
Regulators said the review would apply to Botox, Botox Cosmetic and Myobloc, a product made by Solstice Neurosciences Inc. of San Francisco.
They said the most serious cases included hospitalizations and deaths and occurred mostly in children being treated for cerebral palsy-linked limb spasticity, which is not an approved domestic use of the drug.
An Allergan spokeswoman had no immediate comment, according to the Associated Press.
The news also hit shares of Medicis Pharmaceutical Corp. of Scottsdale, Ariz., which is trying to win regulatory approval for Reloxin, a potential competitor to Botox. Medicis’ shares were down nearly 5% in midday trading with a market value of $1.23 billion.
