Botox® — Black Box Warning
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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.
