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Botox®

Botox® injections are administered to millions of people each year around the world, for both cosmetic and medical purposes. Most people know Botox® as a cosmetic treatment for wrinkles and frown lines. In fact, "Botox® Cosmetic" is the accurate name of the product, marketed by the pharmaceutical giant Allergan.

Black Box Warning for Botox®

In late April 2009, the U.S. Food and Drug Administration (FDA) issued a new requirement for Botox® packaging. All Botox® injection packaging must now carry a severe "black box warning" to tell consumers and physicians that Botox® injections have the potential to spread from the site of injection to other parts of the body, possibly causing serious side effects such as breathing difficulty or problems swallowing.

The FDA stated that it will require the manufacturers of injectable toxins such as Botox® to send a warning letter to all appropriate physicians, describing the same risks. The FDA will also require the manufacturers to provide a "medication guide" to patients who are considering treatment with Botox®.

Many Applications for Botox®

Botox® has been used in a number of ways other than as a "wrinkle-reducer," including for:

• crossed eyes (strabismus, one of the first indications for Botox®)
• eyelid spasms
• severe underarm sweating
• cervical dystonia — neck/shoulder spasms that can produce an abnormal head position and severe pain
• cerebral palsy
• migraine headaches

Botulinum Toxin (Type A)

Botox® Cosmetic and Botox® for migraines, cervical dystonia, etc. are all made from botulinum toxin (type A), a neurotoxin that at full strength is highly poisonous. Botox® injections are extremely tiny amounts of botulinum toxin that smooth out wrinkles in the face by relaxing the facial muscles. The same mechanism underlies the effects of Botox® treatment for strabismus and eyelid, neck, and shoulder spasms.

Botox® injections were approved by the FDA in 2002. However, most people don't realize that since then the FDA has received over 220 reports of serious health problems and 16 deaths linked to Botox® treatment. The advocacy group known as Public Citizen has been calling for stricter warnings on Botox® for a number of years, and their efforts appear to have finally paid off with the April statement from the FDA.

The Botox® black box warning that will be added to the packaging is more commonly done for medications that have life-threatening risks or serious possible complications.

If You Have Been Injured from Botox®

Have you or a loved one been injured after receiving Botox®? If so, contact us to speak with an experienced Botox® attorney who specializes in drug recall litigation & lawsuits. Let us help you win the compensation you need and deserve.