Group seeks Botox warning after 16 death reports

By Lisa Richwine

WASHINGTON (Reuters) - Botox and a similar injection should come with stronger warnings following reports of 16 deaths after the botulinum toxin spread inside the body, a U.S. consumer group said on Thursday.

Public Citizen asked U.S. authorities to require the strongest possible warning, highlighted in a "black box," on Allergan Inc's Botox and Solstice Neurosciences Inc's Myobloc.

Botox is famous for smoothing facial wrinkles but also has approved medical uses such as treating cervical dystonia, or rigid neck muscles. Myobloc is cleared only for the neck condition.

Both injections are made with forms of the botulinum toxin, which blocks nerve impulses to muscles and makes them relax.

Public Citizen said it reviewed 180 reports submitted to the Food and Drug Administration by manufacturers involving patients injected with Botox or Myobloc. The reports detailed cases of muscle weakness, difficulty swallowing or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.

Reports to the FDA do not prove a product caused a particular problem, but the agency uses them to look for patterns of potential complications. Experts believe most problems are under-reported to the agency.

"There are no safety issues raised in the petition that are not already addressed in the labeling for Botox," Allergan said in a statement. The company said it is in frequent dialogue with the FDA to ensure proper labeling and also submits all information it receives on adverse events whether or not they are related to the drug.

Solstice Neurosciences said in a statement that it recently submitted safety data to the FDA and it stood behind the current prescribing information.