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