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August 4th, 2009

"Botox Black Box Warning"

The U.S. Food and Drug Administration (FDA) issued an update on Botulinum Toxin Safety warnings, which include the popular injection, Botox. The Aug. 3, 2009 FDA alert provides information for both healthcare providers and patients.

FDA Announces New Botox Black Box Warning

The FDA announced that it has approved a new black box warning that will be added to the prescribing information for both Botox/Botox Cosmetic ( OnabotulinumtoxinA ) and Myobloc (RimabotulinumtoxinB).

The boxed warnings (which are the highest level of warning issued by the FDA) highlight the potential risk that botulinum toxin may spread throughout the body from the injection site. Symptoms include difficult breathing and swallowing, difficulty speaking and formulating words, muscle weakness and loss of strength, loss of bladder control, and vision problems.

Patients who begin to experience any combination of the listed symptoms after an injection are advised to seek medical attention immediately. The spread of botulinum toxin may result in death if not treated.

FDA Botulinum Toxin Safety Warning Alerts Patients

The FDA safety warning provides information for both healthcare providers and patients. The following health precautions are intended for patients, family members and caregivers:

• A new Medication Guide has also been added to the prescribing information in botulinum products, highlighting the risks and benefits of the products; the FDA encourages all patients and their family members to read through the guide before use and discuss any concerns with their physician or another healthcare provider
• Patients are also encouraged to familiarize themselves with the symptoms of adverse events so they can seek medical attention at the onset of any side effects
• Potential side effects may occur hours or even weeks after treatment
• Patients harmed by botulinum toxin products are encouraged to report their injuries to the FDA

Patients should also be advised that botulinum toxin products are not interchangeable; they have varied indications and dosages.

FDA Announces Name Change in Botulinum Toxin Products

The FDA also announced a name change for the three botulinum toxin products. The name changes emphasize the differing dose to potency levels in the three products. The name changes are as follows:

Trade Name	New Drug Name	Old Drug Name
Botox	OnabotulinumtoxinA	Botulinum toxin type A
Botox Cosmetic	OnabotulinumtoxinA	Botulinum toxin type A
Dysport	AbobotulinumtoxinA	Botulinum toxin type A
Myobloc	RimabotulinumtoxinB	Botulinum toxin type B

(Source: FDA)

For more information about Botox/Botox Cosmetic, Dysport or Myobloc, contact our Botox Lawyers today.