New Botox Side Effects Aesthetic Practitioners Should Know About

New Botox side effects have been announced regarding Botox Cosmetic, the Allergan Aesthetics/AbbVie onabotulinumtoxinA brand. This specifically refers to the use of this popular neurotoxin for aesthetic purposes.

America’s Food & Drug Administration (FDA) included this information in one of its regular side effects updates, published on 18th October 2024. These were safety-related labeling changes approved by FDA Center for Drug Evaluation and Research (CDER).

Whilst FDA notifications have little bearing on UK aesthetic practitioners, it’s wise to be up-to-date on patient safety information from any reputable source. Especially where, as in this case, it refers to new details added to the product label. The MHRA - the Medicines and Healthcare products Regulatory Authority - is the UK’s equivalent government organisation.

The last FDA update regarding the Botox Cosmetic label information prior to this was published on 8th November 2023.

Read on to find out what the new Botox side effects and medication’s label updates are…

Botox side effects update from October 2024

The updates to the approved product label information fall into five main categories:

• Those relating to Botox’s new approval for the treatment of platysmal bands
• Contraindications, warnings and precautions
• Adverse reactions and drug interactions
• Use in specific patient cohorts
• Additions and revisions to the information on Botox’s Medication Guide and Patient Counselling Information.

Below we’ll take you through each one. As this information is taken from an American source - the FDA - you’ll notice the quotes include American English spellings.

New references to using Botox to treat platysma bands

Botox was first approved by the FDA for cosmetic use on 15th April 2002. At that point, it was only approved for upper face treatments. It was specifically approved to temporarily improve the appearance of moderate to severe glabellar lines, or frown lines, between the eyebrows.

Since then, the FDA has further approved cosmetic Botox for other treatment areas.

On 11th September 2013, Botox was approved for the treatment of crow’s feet followed by platysma bands on 18th October 2024.

As a result of this recent approval, the medication’s label needed to be updated to include references to its new indication for vertical neck bands. 

The following additions and revisions were made to section 17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide) - Medication Guide. 

Please note this is an extract highlighting the amendments as italic text below; it does not show the entire text of this section.

“BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when BOTOX Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, forehead lines, or vertical bands connecting the jaw and neck.

“BOTOX Cosmetic is a prescription medicine for adults that is injected into muscles and used for a short period of time (temporary) to improve the look of:

• moderate to severe frown lines between the eyebrows (glabellar lines)
• moderate to severe crow’s feet lines
• moderate to severe forehead lines
• moderate to severe vertical bands connecting the jaw and neck (platysma bands)

“You may receive treatment for frown lines, crow’s feet lines, forehead lines, and vertical bands connecting the jaw and neck at the same time.”

Updates to Botox Cosmetic contraindications, warnings and precautions

These sections on the approved drug label were updated as follows.

Changes to Contraindications section

A new subsection 4.2 was added to the 4. Contraindications section of the approved drug label for Botox Cosmetic. It reads:

4.2 Infection at the Injection Site(s)

BOTOX Cosmetic is contraindicated in the presence of infection at the proposed injection site(s).

Warnings and Precautions updates

Numerous new entries and amendments were made to section 5. Warnings and Precautions.

New subsections were added at 5.10 and 5.11, stating:

“5.10 Dry Eye in Patients Treated with BOTOX Cosmetic

There have been reports of dry eye associated with BOTOX Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist [see Warnings and Precautions (5.9)].

“5.11 Spatial Disorientation, Double Vision or Past-Pointing in Patients Treated for Strabismus

Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision or past pointing. Covering the affected eye may alleviate these symptoms.”

New information was added to 5.2 Spread of Toxin Effect, which states:

“No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX/BOTOX Cosmetic at the labelled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines), or 100 Units (for severe primary axillary hyperhidrosis) have been reported.”

A new subsection was added at 5.5 Cardiovascular System:

“There have been reports following administration of BOTOX/BOTOX Cosmetic 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.”

Section 5.6 Increased Risk of Clinically Significant Effects with Pre-Existing Neuromuscular Disorders was amended. The revisions are highlighted here as italicised text:

“Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from onabotulinumtoxinA [see Warnings and Precautions (5.2, 5.7)]. Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.”

Another new subsection was added at 5.8 Pre-existing Conditions at the Injection Site. This reads: 

“Use caution when BOTOX Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s), ptosis, or when excessive weakness or atrophy is present in the targeted muscle(s).”

Section 5.9 Corneal Exposure and Ulceration in Patients Treated with BOTOX for Blepharospasm received the following italicised additions and revisions:

“Reduced blinking from injection of botulinum toxin products in or near the orbicularis oculi muscle can lead to corneal exposure, persistent cornealepithelial defect, and corneal ulceration, especially in patients with VII nerve disorders.

“Employ vigorous treatment of any corneal epithelial defect. This may require protective drops, ointment, therapeutic soft contact lenses, or closure of the eye by patching or other means.”

New information on adverse reactions and drug interactions with Botox Cosmetic

Section 6 of the approved drug label relates to adverse reactions. This update adds “extensive changes” to clinical trial and postmarketing experiences, as follows:

“6.1 Clinical Trials Experience

Extensive changes; please refer to label

“6.2 Postmarketing Experience

Extensive changes; please refer to label”

7 Drug Interactions also received new information:

“No formal drug interaction studies have been conducted with BOTOX Cosmetic (onabotulinumtoxinA) for injection.”

Updates to use in specific patient cohorts sections

Amendments were made to 8 Use in Specific Patient Populations. These are italicised in the text below.

“The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

“Data

“Animal Data

“When BOTOX Cosmetic (4, 8, or 16 Units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. The no-effect dose for developmental toxicity in these studies (4 Units/kg) is approximately 4 times the average high human dose for glabellar lines, lateral canthal lines, and forehead lines of 64 Units on a body weight basis (Units/kg).

“When BOTOX Cosmetic was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 Units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 Units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits.

“These doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. The developmental no-effect doses in these studies of 1 Unit/kg in rats is approximately equal the average high human dose of 64 Units based on Units/kg, and the developmental no-effect dose of 0.25 Units/kg in rabbits is less than the average high human dose based on Units/kg.

“When pregnant rats received single intramuscular injections (1, 4, or 16 Units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. The developmental no-effect level for a single maternal dose in rats (16 Units/kg) is approximately 16 times the average high human dose of 64 Units based on Units/kg.”

Also within this section, subsection 8.4 Geriatric Use was updated to read: “Extensive changes; please refer to label”.

Lastly, 8.4 Pediatric Use had the following new information added:

“The safety and effectiveness of BOTOX Cosmetic have not been established in pediatric patients.”

Changes to Botox Cosmetic’s Medication Guide and Patient Counselling Information

Medication Guide changes

We covered some of the changes made to 17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide) earlier in this article. These were the ones related to platysma bands. Further changes were made in addition to these, which are outlined in the following extracts in italicised text. 

These relate to patients being advised to tell their aesthetic practitioner if they have received botox injections using other brands in the past four months, and if they’ve had any adverse reactions to them. Changes are highlighted in italics.

“Do not receive BOTOX or BOTOX Cosmetic if you:

• are allergic to any of the ingredients in BOTOX or BOTOX Cosmetic. See the end of this Medication Guide for a complete list of ingredients in BOTOX and BOTOX Cosmetic.
• had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), Jeuveau® (prabotulinumtoxinA-xvfs), Daxxify® (daxibotulinumtoxinA-lanm), or Letybo®
  (letibotulinumtoxinA-wlbg). This may not be a complete list of all botulinum toxin products.
  Especially tell your doctor if you:
• have received any other botulinum toxin product in the last four months.
• have received injections of botulinum toxin, such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), Jeuveau® (prabotulinumtoxinA-xvfs), Daxxify® (daxibotulinumtoxinA-lanm), or Letybo® (letibotulinumtoxinA-wlbg) in the past. This may not be a complete list of all botulinum toxin products.”

Patient Counselling updates

The medication’s Patient Counseling Information was also updated. Additions are noted in the italicised text extracted below:

“Advise the patient to read the FDA-approved patient labeling (Medication Guide). Provide a copy of the Medication Guide and review the contents with the patient.

. . .

“Ophthalmic Adverse Reactions

“Inform patients that BOTOX Cosmetic injection may cause eye dryness. Advise patients to report symptoms of eye dryness (e.g., eye pain, eye irritation, photosensitivity, or changes in vision) to their doctor.”

If you have any concerns regarding these updates or want to know more, we suggest contacting your Botox provider or Allergan Aesthetics. You can also find the full details on the relevant FDA webpage for Botox updates.

For details on any of the botox courses we run here at Harley Academy, browse the aesthetics training courses on our website. 

Alternatively, give our team a call and they can provide you with personalised information on the best botox training options for you. You can book a call with our Course Advisors for a day and time that suits you. We look forward to helping you soon!

All information correct at time of publication