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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.