Botox is the most popular cosmetic surgery treatment, with more than 6 million Botox treatments administered each year.
Botox is derived from Clostridium botulinum, a bacteria found in the natural environment. The bacterium produces a neurotoxin (botulinum toxin) that disrupts the signaling processes that allow neurons to communicate effectively.
Types of wrinkles :
There are two types of wrinkles: dynamic wrinkles and static wrinkles.
Dynamic wrinkles :
These are caused by facial muscles that move when you smile, laugh, and squint. These are often around the lips, on the forehead and between the eyebrows. They are also the “crows’ feet” at the corner of your eyelids. As you age, these wrinkles get deeper and easier to see. Botulinum toxin can be used to make these dynamic wrinkles less noticeable.
Static wrinkles :
These are formed when collagen in the skin starts to thin due to aging and sun damage. It makes the skin on your face stretch and sag, creating fine wrinkles. Botulinum toxin does not erase fine lines and wrinkles. However, there are other ways to reduce their appearance.
How does botox work ?
Botulinum toxin can be injected into humans in extremely small concentrations to prevent signals from the nerve cells reaching muscles. The effect of botulinum toxin causes a reduction in abnormal muscle contraction allowing the muscles to become less stiff.
Medical and cosmetic uses of botox :
Botulinum toxin is predominantly used as a treatment to reduce the appearance of facial wrinkles and fine lines. Beyond aesthetic applications, Botox has been found useful in treating a variety of medical conditions including eye squints, migraines, excess sweating and leaky bladders.
Botulinum toxin is currently approved for the following therapeutic applications :
- Glabellar lines (frown lines between the eyebrows)2
- Canthal lines (crow’s feet)7
How is the botox procedure performed ?
Botulinum toxin is administered by diluting the powder in saline (sodium chloride) and injecting it directly into neuromuscular tissue. It takes 24-72 hours for botulinum toxin to take effect. It may take as long as 5-7 days for the full effect of botulinum toxin to be observed.
Botulinum toxin should not be used in pregnant or lactating women, or by people who have had a previous allergic reaction to the drug or any of its ingredients.
Who can get botulinum toxin injections ?
- You need to be healthy and at least 18 years old before you can get botulinum toxin injections.
- Some people whom should not get botulinum toxin include:
- People who have a neuromuscular disease (such as multiple sclerosis or myasthenia gravis)
- Who are pregnant or nursing
- Who have weakness in certain facial muscles
- Who have skin problems near the injection area
Risks and side effects of botox :
Injections with botulinum toxin are generally well tolerated and there are few side effects. In rare cases an individual may have a genetic predisposition that results in a mild, transient unusual response to the drug.
Some unwanted effects include :
Mild pain, local edema and/or erythema at the injection site, temporary unwanted weakness/paralysis of nearby musculature caused by the action of the toxin, temporary upper lid or brow ptosis (drooping), weakness of the lower eyelid or lateral rectus (a muscle controlling eye movement), redness or bruising in the injection area. This is more likely to happen if you take aspirin or blood-thinning medicine. Ask your doctor if you should stop taking those medicines a few days before getting a botulinum toxin injection.
To help reduce the possibility of side effects, your doctor may recommend using eye drops or ointment after a botulinum toxin injection. You may also be asked to sit upright (not lie down) and avoid pressing on the treated area for about 4 hours after the injection. Also, your doctor may recommend you not exercise for 24 hours after treatment.
Safety Information :
- BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
- Glabellar Lines
BOTOX® Cosmetic (onabotulinumtoxinA) for injection is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Lateral Canthal Lines
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
- 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.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, Dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing Dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
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.
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.
Dysphagia and Breathing Difficulties
Treatment with BOTOX and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
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 glabellar lines was eyelid ptosis (3%).
- 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.
USE IN SPECIFIC POPULATIONS
BOTOX® Cosmetic is not recommended for use in children or pregnant women. It is not known whether BOTOX® Cosmetic is excreted in human milk. Caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.
Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.