HealthDay News — FDA approval for the botulinum toxin drug Botox Cosmetic (onabotulinumtoxin A) has been expanded to include the temporary reduction of moderate-to-severe lateral canthal lines, also known as “crow’s feet.”
The drug was approved in 2002 for the temporary improvement of so-called “frown lines” between the eyebrows, the agency said in news release. The drug, made from the bacterium that causes botulism, keeps affected muscles from tightening, reducing the appearance of wrinkle lines.
The injected drug may now be given at the same time to reduce both crow’s feet and frown lines, the FDA said.
The drug’s safety and effectiveness in treating crow’s feet were established in clinical studies involving 833 adults, who were given either onabotulinumtoxin A or a non-medicinal placebo. Those given the drug showed a greater improvement in crow’s feet lines, the agency said. The most common side effect of the drug when used for this purpose was eyelid edema.
The drug has also been approved for a variety of other indications, including chronic migraine, overactive bladder, muscle spasm, hyperhidrosis, blepharospasm and strabismus.
The drug, in both its cosmetic and non-cosmetic forms, contains a boxed label warning of the possibility of botulism-like adverse systemic effects, which can occur if the drug migrates away from the injection site. These include swallowing and breathing difficulty that can be life-threatening, the FDA said.
However, the agency said there has been no confirmed case of “toxin spread” as long as the product is used at the recommended dosages for FDA-approved reasons.
Botox Cosmetic is manufactured by Allergan, based in Irvine, Calif.