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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.