Black Box Warning for Botox
Action Affects New Botox Rival continued...
The black box warning was just one of several moves the FDA announced regarding the products.
The manufacturers will also be required to:
- Inform users in writing about the potential risk for distant spread at the time of injection.
- Warn doctors and patients about the risks associated with substituting one botulism product for another. The products have different dosing units, which are incompatible, so switching products can result in dangerous overdosing.
- Follow a group of children and adults using Botox, Myobloc, or Dysport off-label to treat involuntary muscle movement and submit safety data to the agency.
Although there is little concern about the safety of Botox and the other products for approved cosmetic uses when they are used as directed, the FDA is requiring these patients to be warned of the risks anyway.
Unger said these users could be at risk if they don’t use the products as directed.
“It is not unusual for patients who use these products for cosmetic purposes to get more injections at more sites than is recommended,” he said.
In a statement issued Thursday afternoon, Allergan noted that reports of serious adverse events have generally been confined to sick patients who received high doses of Botox for therapeutic, and not cosmetic, reasons.
Allergan spokeswoman Caroline Van Hove highlighted Unger’s statement to the media that no adverse events related to distant spread of the drug had been confirmed in patients using Botox as the label indicates for cosmetic reasons.
“Allergan will work with the FDA to appropriately update the label for Botox and Botox Cosmetic in light of the FDA’s conclusion,” she said. “In the interim, caution should be exercised if treating neurologically vulnerable patients with high doses of Botox.”