do you remember the movie “death becomes her”? For some crazy reason, that’s what this whole thing reminds me of….just how willing are we to make a pact with the devil? That’s kind of what my experience felt like, lol! k, here goes….
So the other day, I went to a spa with a good friend, to get some facials.
When they took me in for my appointment, the Esthetician told me that the spa was running a great deal on all kinds of injections. I said I wasn’t interested and they seemed surprised, then said, “There’s nothing wrong with a little Botox” I paused, then said, “Actually, I think there could be a lot wrong with it.”
She seemed stunned and asked why I would think that way.
I said “Because I’ve read the warning labels and side effects, and oh, I don’t know, maybe because botulism is one of the most toxic elements on this planet.”
She laughed and said, I’ll get you to try it, just wait.
And maybe I’m the one getting the last laugh, because she won’t get me to try it.
So why do I feel the way I do about Botox and all of it’s toxic relatives? I wrote a post on Is Botox Dangerous or Safe? before, but this time, I think I’ll let you decide for yourself. I’m just going to post the actual warnings that they are required by law (not by choice) to share. Yet I really wonder if most of the people getting (or even doing) injections have ever really looked through the product warnings?
Anyway, read on, and I’d LOVE to hear your thoughts on this, because I know you have them!!
BOTOX® (onabotulinumtoxinA) Important Information
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment.
Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.
Patients treated for overactive bladder due to neurologic disease
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n=33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n=7).
Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. These reactions include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you experience any such symptoms; further injection of BOTOX® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX®.
Tell your doctor if you have any breathing-related problems. Your doctor will want to monitor you for any breathing problems during your treatment with BOTOX® for detrusor overactivity associated with a neurologic condition. The risk of pulmonary effects in patients with compromised respiratory status is increased in patients receiving BOTOX®.
Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to breastfeed (it is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).
Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-433-8871.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete boxed warning.
The effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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, particularly in those patients who have an underlying condition that would predispose them to these symptoms. (5.2)
- WARNINGS AND PRECAUTIONS__________________________• Potency Units of BOTOX not interchangeable with other preparations of botulinum toxin products (5.1, 11)• Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur (5.2, 5.6)• Care should be taken when injecting in or near vulnerable anatomic structures. (5.3)• Concomitant neuromuscular disorder may exacerbate clinical effects of treatment (5.5)• Use with caution in patients with compromised respiratory function (5.6, 5.7, 5.10)• Corneal exposure and ulceration due to reduced blinking may occur with BOTOX treatment of blepharospasm (5.8)• Retrobulbar hemorrhages and compromised retinal circulation may occur with BOTOX treatment of strabismus (5.9)
• Bronchitis and upper respiratory tract infections in patients treated for upper limb spasticity (5.10)
• Urinary tract infections in patients treated for OAB (5.12)
• Urinary retention: Post-void residual urine volume should be monitored
in patients treated for OAB or detrusor overactivity associated with a neurologic condition who do not catheterize routinely, particularly patients with multiple sclerosis or diabetes mellitus. (5.13)
_______________________________ ________________________________ ADVERSE REACTIONS
The most common adverse reactions (≥5% and >placebo) are (6.1):
• OAB: urinary tract infection, dysuria, urinary retention
• Detrusor Overactivity associated with a neurologic condition: urinary
tract infection, urinary retention
• Chronic Migraine: neck pain, headache
• Spasticity: pain in extremity
• Cervical Dystonia: dysphagia, upper respiratory infection, neck pain,
headache, increased cough, flu syndrome, back pain, rhinitis
• Axillary Hyperhidrosis: injection site pain and hemorrhage, non-axillary
sweating, pharyngitis, flu syndrome
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Patients receiving concomitant treatment of BOTOX and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare- like agents), or muscle relaxants, should be observed closely because the effect of BOTOX may be potentiated (7)
USE IN SPECIFIC POPULATIONS_______________________
• Pregnancy: Based on animal data, may cause fetal harm (8.1)
• Pediatric Use: Safety and efficacy are not established in patients under
18 years of age for the prophylaxis of headaches in chronic migraine, treatment of OAB, detrusor overactivity associated with a neurologic condition, upper limb spasticity, and axillary hyperhidrosis; in patients under 16 years of age for treatment of cervical dystonia; and in patients under 12 years of age for treatment of blepharospasm and strabismus (8.4)
FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: DISTANT SPREAD OF TOXIN EFFECT 1 INDICATIONS AND USAGE
1.1 Bladder Dysfunction 1.2 Chronic Migraine
1.3 Upper Limb Spasticity 1.4 Cervical Dystonia
1.5 Primary Axillary Hyperhidrosis
1.6 Blepharospasm and Strabismus
2 DOSAGE AND ADMINISTRATION
2.1 Instructions for Safe Use
2.2 Preparation and Dilution Technique 2.3 Bladder Dysfunction
2.4 Chronic Migraine
2.5 Upper Limb Spasticity
2.6 Cervical Dystonia
2.7 Primary Axillary Hyperhidrosis
3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS
4.1 Known Hypersensitivity to Botulinum Toxin 4.2 Infection at the Injection Site(s)
4.3 Urinary Tract Infection or Urinary Retention
5 WARNINGS AND PRECAUTIONS
5.1 Lack of Interchangeability between Botulinum Toxin Products 5.2 Spread of Toxin Effect
5.3 Injections In or Near Vulnerable Anatomic Structures
5.4 Hypersensitivity Reactions
5.5 Pre-Existing Neuromuscular Disorders
5.6 Dysphagia and Breathing Difficulties in Treatment of Cervical
5.7 Pulmonary Effects of BOTOX in Patients with Compromised
Respiratory Status Treated for Spasticity or for Detrusor
Overactivity associated with a Neurologic Condition
5.8 Corneal Exposure and Ulceration in Patients Treated with BOTOX
5.9 Retrobulbar Hemorrhages in Patients Treated with BOTOX for
5.10 Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity
5.11 Autonomic Dysreflexia in Patients Treated for Detrusor Overactivity associated with a Neurologic Condition
5.12 Urinary Tract Infections in Patients with Overactive Bladder 5.13 Urinary Retention in Patients Treated for Bladder Dysfunction 5.14 Human Albumin and Transmission of Viral Diseases
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience 6.2 Immunogenicity
6.3 Post-Marketing Experience
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology
14 CLINICAL STUDIES
14.1 Overactive Bladder (OAB)
14.2 Detrusor Overactivity associated with a Neurologic Condition 14.3 Chronic Migraine
14.4 Upper Limb Spasticity
14.5 Cervical Dystonia
14.6 Primary Axillary Hyperhidrosis
* Sections or subsections omitted from the full prescribing information are not listed.
Gosh, I don’t know–is it worth it? PLEASE let us know your thoughts!!!
Laurie & Tiffany