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First approved by the FDA in 1989, Botox is an injectable medication that can be used for both cosmetic and medical procedures. Botox, a purified form of the botulinum toxin type A protein, is produced by Allergan, Inc. and can be used to treat:

• excessive blinking (blepharospasm)
• excessive sweating
• frown lines and wrinkles
• migraines
• neck spasms, neck pain and/or abnormal posture (collectively known as cervical dystonia).

Unfortunately, however, Botox is known to cause some rare but life-threatening side effects. Given the severity of possible Botox side effects, the Food and Drug Administration has issued a series of Botox warnings, the latest of which requires Allergan, Inc. to include a black box warning on Botox labels.

Anyone injured after receiving Botox injections, as well as families of deceased Botox patients, should meet with an experienced Botox lawyer to learn more about their legal rights and find out if they are entitled to a settlement for their injuries.

Botox Warning 2008

In January 2008, a non-profit consumer organization known as Public Citizen urged the FDA to:

• require Allergan, Inc. to include "black box" warnings on Botox labels (Black box warnings are the most serious type of FDA warning, as they highlight a medication's potential of causing life-threatening side effects.)
• develop a method of mitigating the damage done when Botox spreads from the injection site to other parts of the body.

Public Citizen's request was generated after this group conducted a study that found that:

• Between November 1997 and December 2006, over 650 individuals developed adverse reactions from Botox injections.
• 180 of these patients developed pneumonia (Of these, 87 required hospitalization).
• 16 people died due to severe Botox side effects (Of these, 4 deaths affected children younger than 18 years old).

A more recent study published in the Journal of American Academy of Dermatology (Sept. 2005) revealed that as many as 28 individuals had died following Botox injection treatments (none of these resulted from cosmetic Botox injections).

FDA Botox Warning

Following Public Citizen's petition, the following month (February 2008), the FDA issued a national public advisory regarding the life-threatening side effects of Botox, which may include:

• arrhythmia
• heart attack
• respiratory depression
• severe allergic reaction.

The FDA also initiated a massive safety review focused on the possible side effects of Botox injections.

Botox Warning Symptoms

It's vital that patients receiving Botox treatments understand the symptoms associated with severe Botox side effects. Indications that Botox is causing serious health complications include:

• abdominal pain
• breathing difficulties (including shortness of breath without physical activity)
• chest pain
• facial and/or tongue swelling
• feelings of anxiety
• hives and/or skin rash
• lightheadedness
• nausea and/or vomiting
• palpitations
• sweating.

Botox patients should seek emergency medical care to save their lives, should they develop any of the above symptoms.

New Botox Warning: FDA Botox Warning 2009

Following the culmination of the FDA's safety review, on April 30, 2009, the FDA announced that Botox products must carry a black box warning label to alert the public of possible adverse reactions associated with Botox injections.

Additionally, as per the request of Public Citizen, the FDA is requiring Botox manufacturers to create and implement a "Risk Evaluation and Mitigation Strategy" (REMS) that will inform the public regarding:

• the possibility and side effects of botulinum toxin spreading from the injection side
• proper use of Botox
• risk factors for severe Botox side effects.

It's also important to note that the FDA has required black box warnings to be posted on Dysport, a new alternative to Botox that is also derived from botulinum toxin.

Have you or a loved one been injured after receiving Botox treatments? If so, contact a Botox lawyer who can evaluate your case and help you win the compensation you deserve.

"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 Announ...

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