Calls for Botox warning after many deaths

[Pastor Dale Morgan]

*Perilous Times

Calls for Botox warning after many deaths*

By Lisa Richwine in Washington

January 25, 2008 09:09am
Article from: 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 US consumer group said.

Public Citizen asked US authorities to require the strongest possible
warning, highlighted in a "black box," on Allergan Inc's Botox and
Solstice Neuroscience 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 (FDA) 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.

Officials at Allergan and Solstice did not immediately respond to
requests for comment.

Allergan projected in November that worldwide sales for Botox would top
$US1.1 billion ($1.26bn) in 2007.

Sixteen cases reported to the FDA were fatal, including four involving
children under 18, Public Citizen said. Eighty-seven patients needed
hospital care.

Dr Sidney Wolfe, director of Public Citizen's Health Research Group,
said such problems could occur if botulinum toxin spread from the
injection site to places such as the oesophagus, causing partial paralysis.

Instructions for Botox and Myobloc mentioned the issue but it was easy
to miss, he said.

Early symptoms include dry mouth, difficulty breathing or swallowing,
slurred speech, drooping eyelids and muscle weakness.