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The Steering Committee
Alastair Carruthers, MD, FRCP(C)
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Product Information


 

Botulinum Toxins

Botulinum Toxin Type A Purified Neurotoxin Complex (BOTOX® COSMETIC)

Indications: BOTOX COSMETIC is indicated for the temporary improvement in the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity in patients aged ≤65 years.

Contraindications: BOTOX COSMETIC is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any of its components.

Adverse events: In clinical trials, the most frequently reported adverse events following injection of BOTOX COSMETIC for glabellar lines were headache, respiratory infection, flu syndrome, blepharoptosis, and nausea. Less frequent adverse events: facial pain, injection-site erythema, parasthesia, and muscle weakness.1

1BOTOX COSMETIC [package insert]. Irvine, California: Allergan, Inc; 2006.

For more information on BOTOX COSMETIC, click here.


Warning: Adverse Reactions to BOTOX Use. February 8, 2008.


Botulinum Toxin Type B Injectable Solution (MYOBLOC®)

Indications: MYOBLOC is indicated for the treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain. Aesthetic uses of this product are considered off label.

Contraindications: MYOBLOC is contraindicated in patients with known hypersensitivity to any of its components.

Adverse events: In clinical trials, the most frequently reported adverse events following injection of MYOBLOC for aesthetic uses included injection-site pain. Adverse events associated with MYOBLOC use for cervical dystonia, including dysphagia, dyspepsia, and dry mouth, have not been reported following aesthetic use.1

1MYOBLOC [package insert]. San Fransisco, California: Solstice Neurosciences, Inc.; 2004.

For more information on MYOBLOC, click here.


FDA Warning: Adverse Reactions to MYOBLOC. February 8, 2008.


Clostridium Botulinum Type A Toxin-Hemagglutinin Complex (Dysport®)

Indications: Dysport is indicated for use outside of the United States for spasticity of the upper arm in adults following a stroke, dynamic equinus foot deformity due to spasticity in ambulant pediatric cerebral palsy patients aged ≥2 years (only in hospital specialist centers with appropriately trained personnel), spasmodic torticollis in adults, blepharospasm in adults, hemifacial spasm in adults, axillary hyperhidrosis, and improvement in the appearance of moderate-to-severe glabellar lines.
FDA approval for use in the United States is pending.

Contraindications: Dysport is contraindicated in patients with known hypersensitivity to any of its components; those diagnosed with myasthenia gravis or Eaton-Lambert (myasthenic) syndrome; and those with any signs of infection at the proposed injection site.

Adverse events: In clinical trials, the most frequently reported adverse events following injection of Dysport for glabellar lines were headache, eye edema, injection-site pain, stinging and warmth, facial paresis, eyelid ptosis, keratoconjunctivitis sicca, and pruritis.1

1Dysport [package insert]. Wrexham, UK: Ipsen Biopharm Limited; 2005.

For more information on Dysport, click here.





Injectable Dermal Fillers: Hyaluronic Acid

Hyaluronic Acid Gel (Juvéderm™ Ultra, Juvéderm™ Ultra Plus)

Indications: Juvéderm Ultra and Juvéderm Ultra Plus are indicated for injection into the mid-to-deep dermis for the correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds).

Contraindications: Juvéderm Ultra and Juvéderm Ultra Plus are contraindicated in patients with severe allergies due to a history of anaphylaxis or presence of multiple severe allergies and those with a history of allergies to gram-positive
bacterial proteins.

Adverse events: In clinical trials, the most frequently reported adverse events following injection of Juvéderm Ultra or Juvéderm Ultra Plus were redness, pain, firmness, swelling, lumps/bumps, bruising, itching, and/or discoloration at the injection site.1-2

1Juvéderm Ultra [package insert]. Irvine, California: Allergan, Inc; 2008.
2Juvéderm Ultra Plus [package insert]. Irvine, California: Allergan, Inc; 2008.

For more information on Juvéderm Ultra and Juvéderm Ultra Plus, click here.




Hylan B Gel (Hylaform®, Hylaform® Plus)

Indications: Hylaform and Hylaform Plus are indicated for injection into the mid-to-deep dermis for the correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds).

Contraindications: Hylaform and Hylaform Plus are contraindicated in patients with known history of hypersensitivity to avian proteins and/or allergies specific to birds; for breast augmentation; for implantation into tendon, bone, ligament, or muscle; for injection into blood vessels; and in patients taking anticoagulant therapy (eg, aspirin, NSAIDs). 

Adverse events: In a randomized, controlled trial, the most frequently reported adverse events following injection of Hylaform or Hylaform Plus were erythema, bruising, swelling, pain, pruritis, and/or desquamation at the injection site.1-2

1Hylaform [package insert]. Ridgefield, NJ: Genzyme Biosurgery; 2004.
2Hylaform Plus [package insert]. Ridgefield, NJ: Genzyme Biosurgery; 2004.

For more information on Hylaform, click here.

For more information on Hylaform Plus, click here.




Non–Animal-Stabilized Hyaluronic Acid Gel (Captique™)

Indications: Captique is indicated for the correction of moderate-to-severe facial wrinkles.

Contraindications: Captique is contraindicated in patients with severe allergies due to a history of anaphylaxis or presence of multiple severe allergies; history of allergies to gram-positive bacterial proteins; and those on immunosuppressive therapy and those using anticoagulants (eg, aspirin, NSAIDs); also contraindicated for implantation into blood vessels.

Adverse events: The most frequently reported adverse events associated with Captique injection include bruising, redness, swelling, pain/tenderness, peeling, and/or itching at the injection site.1

1American Society of Plastic Surgeons. Injectables at a Glance. Available at: http://www.plasticsurgery.org.
Accessed July 17, 2008.

Form more information on Captique, click here.




Non–Animal-Stabilized Hyaluronic Acid Gel (Perlane®)

Indications: Perlane is indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate-to-severe facial folds and wrinkles (eg, nasolabial folds).

Contraindications: Perlane is contraindicated in patients with severe allergies due to a history of anaphylaxis or presence of multiple severe allergies; history of allergies to gram-positive bacterial proteins; history of bleeding disorders; and those on immunosuppressive therapy and those using anticoagulants (eg, aspirin, NSAIDs); and for implantation into anatomical spaces other than the dermis or superficial layer of the subcutis; and implantation into blood vessels.

Adverse events: In clinical trials, the most frequently reported adverse events following injection of Perlane included bruising, redness, swelling, pain/tenderness, and/or itching at the injection site.1

1Perlane [package insert]. Scottsdale, Arizona: Medicis Aesthetics, Inc.; 2004.

For more information on Perlane, click here.




Non–Animal-Stabilized Hyaluronic Acid Gel (Restylane®)

Indications: Restylane is indicated for mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds).

Contraindications: Restylane is contraindicated in patients with severe allergies due to a history of anaphylaxis or presence of multiple severe allergies; history of allergies to gram-positive bacterial proteins; and in patients on immunosuppressive therapy and those using anticoagulants (eg, aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs]); also contraindicated for implantation into blood vessels.

Adverse events: In clinical trials, the most frequently reported adverse events following injection of Restylane included bruising, redness, swelling, pain, tenderness, and/or itching at the injection site.1

1Restylane [package insert]. Scottsdale, Arizona: Medicis Aesthetics, Inc.; 2005.

For more information on Restylane, click here.




Hyaluronic Acid Gel (Elevess™)

Indications: Elevess is indicated for the injection into the mid-to-deep dermis for the correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds).

Contraindications: Elevess is contraindicated in patients with severe allergies due to a history of anaphylaxis or presence of multiple severe allergies and those with a history of allergies to gram-positive bacterial proteins.

Adverse events: In clinical trials, the most frequently reported adverse events following injection of Elevess was bruising, redness, swelling, pain, tenderness, itching, and nodule formation at the injection site.1

1Elevess [package insert]. Woburn, Massachusetts: Anika Therapeutics, Inc.; 2006.





Injectable Dermal Fillers: Collagen Filler

Autologous Human Collagen (Autologen™)

Indications: Autologen is indicated for the treatment of wrinkles, deep folds (eg, nasolabial folds), and frown lines, especially vertical frown lines between eyebrows (glabellar region); lip augmentation; filling depressed scars and similar indentations.1

Contraindications: Autologen is contraindicated in patients with allergies to local anesthetics.1

Adverse events: Frequently reported adverse events associated with injection of Autologen include bruising, lumps and bumps, uneven skin, skin necrosis, granulomas, and delayed hypersensitivity reactions.2

1Dermal Filler: Autologous human collagen (Autologen). Available at http://www.smartskincare.com/treatments/fillers/injautograft_human-collagen.html. Accessed July 17, 2008.
2Derma Network. Autologen as a dermal filler. Available at: http://www.dermanetwork.org/glossary/2007/10/autolgen_as_a_dermal_filler.html. Accessed July 17, 2008.




Bovine Collagen Implants (Zyderm®, Zyplast®)

Indications: Zyderm and Zyplast are indicated for the correction of contour deformities of the dermis in non–weight-bearing areas.

Contraindications: Zyderm and Zyplast are contraindicated in patients with allergic reactions to required skin test, injectable collagen products or lidocaine, or history of severe anaphylactic reactions; pregnant women; patients undergoing desensitization injections to meat products; breast augmentation; implantation into bone, tendon, ligament, or muscle.

Adverse events: Frequently reported adverse events associated with implantation of Zyderm and Zyplast include allergic reaction(s), erythema, swelling, pain, itching, discoloration, and/or tenderness at implant site.1-2

1Zyderm [package insert]. Fremont, California: McGhan Medical Corporation; 2000.
2Zyplast [package insert]. Fremont, California: McGhan Medical Corporation; 2000.

For more information on Zyderm and Zyplast, click here.




Human Tissue-Derived Collagen Implants (CosmoDerm®, CosmoPlast®)

Indications: CosmoDerm and CosmoPlast are indicated for the correction of soft-tissue contour deficiencies (eg, wrinkles, acne scars) in the superficial papillary dermis.

Contraindications: CosmoDerm and CosmoPlast are contraindicated in patients with known allergy to lidocaine; severe allergies due to history of anaphylaxis; inflamed/infected skin condition; for increasing breast size; for implanting into bone, tendon, ligament, or muscle.

Adverse events: In a clinical study, the most frequently reported adverse events associated with implantation of CosmoDerm and CosmoPlast included redness, pain/tenderness, induration, and/or swelling at injection site.1-2

1CosmoPlast [package insert]. Irvine, California: Allergan, Inc; 2007.
2CosmoDerm [package insert]. Irvine, California: Allergan, Inc; 2007.

For more information on CosmoPlast and CosmoDerm, click here.




Injectable Donor Fascia (Fascian™)

Indications: Fascian is indicated to treat the lip and nasolabial fold areas; acne and chicken pox; depressed scars; post-surgical scars; and fat loss in cheeks.1

Contraindications: Fascian is contraindicated in patients with active infection at the injection site, active herpetic dermatitis, or history of a connective or autoimmune disease. Should also be avoided in patients with known allergies to polymyxin B sulfate, bacitracin, and/or gentamicin.2

Adverse events: Fascian may transmit infectious agents. Patients who are allergic to polymyxin B sulfate, bacitracin, and/or gentamicin should be managed accordingly. Intradermal injection may produce lumpiness and a persistent inflammatory response. May cause bruising at the injection site.1

1 Fascian [package insert]. Beverly Hills, California: Fascia Biosystems, LLC; 1999.
2Gayre CS. Currently Available Cosmetic Filler Agents. In: Lipham WJ. Cosmetic and Clinical Applications of Botulinum Toxin. Thorofare, NJ: SLACK Incorporated; 2003:87-132.




Porcine Collagen (Evolence®)

Indications: Evolence is indicated for the correction of moderate-to-deep facial wrinkles and nasolabial folds.

Contraindications: Evolence is contraindicated for use in patients with known hypersensitivity to any collagen products or undergoing desensitization injections to porcine products; those with an allergic reaction to collagen or history of anaphylactic reactions; also contraindicated for injection into spaces other than the dermis of the face. 

Adverse events: Adverse events associated with injection of Evolence include bruising or bleeding (especially with concomitant aspirin or NSAID use), swelling, erythema, pain, pruritus, or induration at the injection site.1

1Evolence [package insert]. Morris Plains, NJ: ColBar LifeScience Ltd.; 2008.

For more information on Evolence, click here.





Injectable Dermal Fillers: Calcium Hydroxylapatite Microspheres

Calcium Hydroxylapatite Microspheres Implant (Radiesse®)

Indications: Radiesse is indicated for subdermal implantation for the correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds), and for the correction of the signs of facial lipoatrophy in people with human immunodeficiency virus (HIV).

Contraindications: Radiesse is contraindicated in patients with severe allergies due to a history of anaphylaxis, and in those with known hypersensitvity to any of its components; also contraindicated for implantation into blood vessels.

Adverse events: In a randomized, controlled trial, the most frequently reported adverse events associated with the injection of Radiesse included bruising, itching, lumping erythema, edemas, and/or pain.1

1Radiesse [package insert]. Franksville, Wyoming: BioForm Medical Inc.; 2006.

For more information on Radiesse, click here.





Injectable Dermal Fillers: Synthetic Poly-L-Lactic Acid

Injectable Poly-L-Lactic Acid (Sculptra™)

Indications: Sculptra is indicated for the restoration and/or correction of facial lipoatrophy in people with HIV. Aesthetic uses are considered off label.

Contraindications: Sculptra is contraindicated in patients with known hypersensitivity to any of its components and for implantation into blood vessels.

Adverse events: In clinical trials, the most frequently reported adverse events associated with the injection of Sculptra included bruising, edema, discomfort, hematoma, inflammation, and/or erythema.1

1Sculptra [package insert]. Bridgewater, New Jersey: Dermik Laboratories; 2006.

For more information on Sculptra, click here.





Injectable Dermal Fillers: Polymethylmethacrylate Microspheres

Polymethylmethacrylate Microspheres Implants (ArteFill®)

Indications: ArteFill is indicated for the correction of nasolabial folds.

Contraindications: ArteFill is contraindicated in patients with severe allergies due to history of anaphylaxis or presence of multiple severe allergies; lidocaine sensitivity; history of allergies to bovine collagen products; patients undergoing desensitization to meat products; known susceptibility to keloid formation or hypertrophic scarring; implantation into blood vessels; and lip augmentation and injection into the vermilion or wet mucosa of lip.

Adverse events: Commonly reported adverse events associated with injection of ArteFill include lumpiness, swelling, redness, or itching at the injection site.1-2

1ArteFill [package insert]. San Diego, California: Artes Medical, Inc.; 2007.

For more information on ArteFill, click here.





Topical Creams

ELA-Max® Cream

Indications: ELA-Max Cream is indicated for the temporary relief of pain associated with minor cuts and abrasions of the skin, minor burns, including sunburn, minor skin irritation, and insect bites.

Contraindications: ELA-Max Cream is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Adverse events: ELA-Max cream may cause erythema, edema, or abnormal sensation; urticaria; angioedema; bronchospasm; and shock. Adverse reactions of lidocaine are similar in nature to those observed with other amide local anesthetic agents (eg, dizzinesss, numbness).1

1ELA-Max Cream [package insert]. Ferndale, Michigan: Ferndale Laboratories, Inc.; Pittsburg, California:
BioZone Laboratories, Inc.;1998.

For more information on ELA-Max Cream, click here.




Eutectic mixture of local anesthetics (EMLA®)

Indications: EMLA Cream/Patch is indicated for the skin in connection with needle insertion (eg, intravenous catheters or blood sampling) and superficial surgical procedures.

EMLA Cream is indicated for the genital mucosa (eg, prior to superficial surgical procedures or infiltration anaesthesia) and leg ulcers to facilitate mechanical cleansing/debridement.

Contraindications: EMLA Cream/Patch is contraindicated in patients with hypersensitivity to local anaesthetics of the amide type or to any other component of the product; and in patients with congenital or idiopathic methemoglobinemia.

Adverse events: EMLA Cream/Patch may cause paleness and erythema, mild burning, or itching sensation. Rare: Methemoglobinemia in children, discrete local lesions at the application site (purpuric or petechial). In rare cases, local anaesthetic preparations have been associated with allergic reactions.1

1EMLA [package insert]. Willmington, Pennsylvania: AstraZeneca, LP; 2000.

For more information on EMLA, click here.


FDA Advisory: Life-Threatening Side Effects of Numbing Ingredients. February 9, 2007.