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Botox® — Black Box Warning

Botox® now has a "black box" warning on its Prescribing Information and labeling. A black box warning is the most eye-catching, bold-font, boxed text that the FDA can recommend. The warning language is placed in a prominent black border (box) on the product's label. The FDA's black box warnings are usually reserved for drugs that have very severe and/or life-threatening potential side effects.

Botox®, Myobloc, Dysport

Botox® Cosmetic® will have the new black box warning, and so will tow other similar botulinum toxin products:

• Myobloc (botulinum toxin type B), from Solstice Neurosciences
• Dysport, a new FDA-approved product made by Ipsen Biopharm Ltd.

All three products are FDA-approved for treating cervical dystonia (painful spasms in the neck and shoulder muscles), and Botox® and Dysport are FDA-approved for cosmetic use, to smooth frown lines and wrinkles in the face.

The Reason for the Botox® Black Box Warning

On April 30, 2009, the FDA issued the new requirement for the Botox® black box warning based on many reports of the botulinum toxin spreading from the site of injection to other parts of the patient's body, causing symptoms such as:

• unexpected loss of strength
• trouble swallowing
• trouble saying words clearly
• trouble breathing
• muscle weakness
• loss of bladder control
• hoarseness or trouble talking
• drooping eyelids
• double vision
• blurred vision

Black Box Warning and REMS

Several other safety changes are being required of Botox® and its manufacturer, Allergan Inc. The FDA is mandating that Allergan perform a Risk Evaluation and Mitigation Strategy (REMS), which will include:

• a Medication Guide (an FDA-approved handout that will be given to patients who are going to be treated with the medication — in this case, Botox®)

• a Communication Plan (to make it clear to physicians and other healthcare providers that Botox®, Myobloc and Dysport botulinum toxin products are not interchangeable)

Special Concerns

The Botox® label change will also warn doctors and patients that individuals with any of the following conditions should be monitored very closely when they're treated with Botox®:

• peripheral motor neuropathic diseases
• amyotrophic lateral sclerosis (ALS, also known as "Lou Gehrig's disease")
• neuromuscular junction disorders such as myasthenia gravis or Lambert-Eaton syndrome

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.