A consumer group on Thursday called for Irvine-based Allergan Inc.’s Botox and a similar drug to be labeled with a “black box” warning after reports of 16 deaths and other problems after the main ingredient botulinum toxin spread inside the body.
Washington, D.C.-based Public Citizen asked regulators to require the strongest possible warning on Botox and Myobloc, which is produced by Solstice Neurosciences Inc. of San Francisco.
Allergan said it sees no need for labeling beyond what Botox already carries.
The consumer group said it reviewed 180 reports submitted to the Food and Drug Administration by manufacturers involving patients injected with either Botox or Myobloc. The reports detailed cases of muscle weakness, difficulty swallowing or aspiration pneumonia, which is caused by breathing foreign material into the lungs.
Public Citizen said that 16 of those cases reported were fatal, including four involving children under 18.
Botox is used for treating rigid neck muscles as well as smoothing facial wrinkles. Myobloc is only cleared for the neck condition.
Separately, Allergan signed a deal with the Clinique unit of New York-based Estee Lauder Cos. to develop a new line of skincare products that would be sold exclusively through physicians rather than stores. Allergan and Lauder said the line is expected to launch this fall under the Clinique brand name.
Allergan is no stranger to working with cosmetics companies. It produces the Prevage anti-aging line with Elizabeth Arden Inc. of New York.
