Botox Warning by FDA after 16 Deaths

Botox and Myobloc - FDA Alert Warning.

FDA NEWS UPDATE February 8, 2008

FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses.

The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.

Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals.

You can find more information about Botox and how to report an issue visit HERE

PHILADELPHIA (CBS 3) ― In health, Medical Reporter Stephanie Stahl has details regarding a storm of reaction following a warning about Botox from a consumer group.

Millions of people have been safely injected with Botox, it is FDA cleared to treat wrinkles and other medical conditions like muscle contractions. But one group said it is dangerous and stronger warnings are needed.

Botox injections have become one of the most popular cosmetic treatments, a quick shot to smooth wrinkles.

"It gives me a more youthful appearance," said Khadijah Brown who gets Botox treatments.

But a health advocacy group, Public Citizen, said patients should be warned the botulism poison in Botox that paralyzes muscles can be dangerous.

"Nobody should be dying of Botox, and they wouldn't be dying if the government and companies were doing a better job," said Dr. Sidney Wolfe,
Director of Public Citizen's Health Research Group.

The group has petitioned the FDA to put its strongest warning, a black box label, on Botox claiming it can cause everything from muscle weakness to difficulty swallowing, even death.

"This very powerful neurotoxin migrates from where it is injected to the esophagus, paralyzes the esophagus, you can't swallow. You may choke, cough up food, water goes into your lungs you get pneumonia and can die," said Dr. Wolfe.

After reviewing FDA data, Public Citizen said 180 people developed life threatening conditions after receiving injections, including 16 deaths.

But in 15 of the deaths cited by Public Citizen, the drug was used for medical purposes, not wrinkle treatment, and dermatologists say the scientific evidence just doesn't support this kind of consumer scare.

"The though of dying from Botox Cosmetic I don't think should enter someone's mind at this point in time. The adverse effects we get are generally minor, limited to maybe some bruising and short term headache," said Dermatologist John Romano.

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.