The U.S. Food and Drug Administration (FDA) announced a Botox black box warning, Aug. 3, 2009. The black box warning follows an earlier safety evaluation of Botox Cosmetics and two other botulinum products, concluding that the prescribing information must be updated to ensure safe consumer use.
FDA Safety Alert Includes Botox and More
The alert includes the following products:
- Botox/Botox Cosmetic (OnabotulinumtoxinA)
- Myobloc (RimabotulinumtoxinB)
- Dysport (AbobotulinumtoxinA)
Black Box Warning Highlights Potential Health Risks
The FDA alert announced that it approved a series of updates to the prescribing information for both Botox and Myobloc.
A Black box warning was added for Botox and Myobloc to warn healthcare professionals of the risk that the botulinum toxin may spread from the injection site, which may result in death. Signs that this may be occurring include:
- Muscle weakness
- Loss of strength
- Difficulty speaking clearly
- Loss of bladder control
- Difficulty breathing
- Difficulty swallowing
- Double or blurred vision
New Medication Guide Intended for Consumers
A Risk Evaluation and Mitigation Strategy (REMS) highlighting the risks and benefits of the botulinum toxin products has also been included.
The FDA encourages all consumers to read the new Medication Guide before using one of the listed products and to familiarize themselves with the potential health risks and the signs and symptoms. Should a patient begin to experience any of the symptoms listed above, they are advised to seek immediate medical attention.
The FDA is asking all Botox, Myobloc and Dysport patients to report any side effects or adverse events to the FDA. Changes have also been made to the names and indications.
(Source: FDA)
For more information about the potential health risks associated with botulinum toxin products, contact our botox lawyers today. If you’ve been harmed by one of the mentioned injections, we can help you seek and recover compensation for your injuries and losses.
