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Date:7/23/2009

Important Safety Information

Who should not be treated with BOTOX((R))

BOTOX((R)) injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in the BOTOX((R)) product.

Warnings

Serious heart problems and serious allergic reactions have been reported rarely. If you think you're having an allergic reaction or other reaction, such as difficulty swallowing, speaking, or breathing, call your doctor immediately.

Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.

Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia (difficulty swallowing) and respiratory compromise from typical doses of BOTOX((R)).

Precautions

Patients or caregivers should be advised to seek immediate medical attention if swallowing, speech, or respiratory disorders arise.

Side Effects

Localized pain, infection, inflammation, tenderness, swelling, redness and/or bruising may be associated with the injection.

The most common side effects (3-10% of patients) include injection-site pain and bleeding, non-underarm sweating, infection, sore throat, flu, headache, fever, neck or back pain, itching and anxiety.

Additional Important Safety Information

The FDA on April 30, 2009, in its update to the early communication sent in 2008, gave the following recommendations:

  • Understand that dosage strength (potency) expressed in "Units" or "U" are different among the botulinum toxin products; clinical doses exp
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SOURCE International Hyperhidrosis Society
Copyright©2009 PR Newswire.
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