Botox® injections work by relaxing the facial muscles that cause your skin to wrinkle and furrow causing lines. Over one million people have been treated since it was approved by the FDA in 2002. Botox® is most the affordable and effective treatment for frown lines, crow’s feet and forehead creases.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
Lack of Interchangeability between Botulinum Toxin Products
The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines) have been reported.
Injections In or Near Vulnerable Anatomic Structures Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for indications pertaining to these injection sites. Some patients had pre-existing dysphagia or significant debility. Pneumothorax associated with injection procedure has been reported following the administration of BOTOX® near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.
Hypersensitivity Reactions Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular System There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Pre-existing Neuromuscular Disorders Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.
Pre-existing Conditions at the Injection Site Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Human Albumin and Transmission of Viral Diseases This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
The most frequently reported adverse event following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.