Q&A 331.4
Which dental local anaesthetics are made with natural rubber latex?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp
Date prepared: January 2016
Background
Natural rubber latex is found in thousands of everyday consumer and healthcare items including examination and surgical gloves, surgical masks, dental dams, bungs in medicine vials, needle sheaths, syringes, injection ports and intravenous tubing [1]. Up to 6% of the general population are thought to have antibodies to proteins in natural rubber latex, and about 1% of the UK population and 10% of health personnel report symptoms of allergy on contact with natural rubber latex [1-3].
There are two types of natural rubber latex allergy.
· Type I reaction is immediate hypersensitivity to natural rubber latex proteins caused by production of immunoglobulin E antibodies. It occurs within minutes of contact with natural rubber latex and can be life threatening. Symptoms can be mild, such as nettle rash (urticaria) anywhere on the body, or be more severe with swelling in the face, throat and/or mouth, difficulty breathing, severe asthma, abdominal pain, nausea or vomiting. In extreme cases anaphylactic shock can occur. Some people with type I natural rubber latex allergy may experience symptoms by being in a room where powdered gloves containing natural rubber latex are being used even though they do not touch the gloves. Reactions may vary in severity from patient to patient, and from time to time in an individual patient.
· Type IV reaction (known as allergic contact dermatitis) is a delayed reaction to chemicals used in the rubber manufacturing process, rather than natural rubber latex itself. It occurs six to 48 hours after exposure resulting in a red itchy rash with blistering and weeping in the area in contact with natural rubber latex, but can spread to other areas of the body. It is itchy and uncomfortable but not life threatening [1,3].
Natural rubber latex can also cause irritant contact dermatitis, but this is not a true allergy [4]. It is caused by maceration of the skin, often associated with sweating under occlusion (such as when wearing rubber gloves) and can progress to low-grade eczema with itching, redness and scaling [3].
People with allergy to natural rubber latex should avoid contact with all products containing natural rubber latex [1,3-6]. Airborne exposure should be reduced as much as possible [5]. Contact between natural rubber latex and a mucosal surface (such as mouth and nose) may cause a more severe reaction than contact with intact skin since greater amounts of natural rubber latex protein are absorbed systemically [3]. Unfortunately most products are not labelled to warn that they contain natural rubber latex. In the EU, the package leaflet of medicinal products must state if the container of the product contains latex rubber [7].
This Medicines Q&A provides a list of local anaesthetic preparations used in dentistry and notes whether natural rubber latex is used as a material in the manufacture of the product, its container and packaging.
For advice on managing patients with allergy to local anaesthetic agents due to other causes, see Medicines Q&A Allergy to local anaesthetic agents used in dentistry – what are the signs, symptoms, alternative diagnosis and management options?
Answer
The following table lists local dental anaesthetics, and topical anaesthetics used by dental healthcare professionals, that are currently available in the UK; natural rubber latex is not used as a material in the manufacture of any of the products, their container and packaging. However, it is not possible to state that a product is completely free of natural rubber latex proteins, and dental health professionals should always be cautious when providing care to people with natural rubber latex allergy, especially those with type I allergy or poorly controlled asthma. The presence of asthma, especially poorly controlled asthma, is a major risk factor for more severe reactions in people with type I natural rubber latex allergy [1].
The US Food and Drug Administration strongly recommends that the terms ‘latex-free’ and ‘does not contain latex’ are not used in medical product labelling. This is because the term ‘latex’ is not sufficiently specific as it could also refer to synthetic latex (not derived from natural rubber latex). In addition, it is not possible to state that a product does not contain natural rubber latex as there are no tests available to show a product is completely free of natural rubber latex proteins, and products could become accidentally contaminated with natural rubber latex during or after manufacture [8]. There is no equivalent guidance from UK or European regulatory agencies.
Other precautions dental staff should take when caring for patients with natural rubber latex allergy include:
· Do not use gloves containing natural rubber latex [3], especially powdered gloves which increase the risk of sensitisation as natural rubber latex proteins are carried and made airborne by powder particles [4-5].
· Wash hands to remove natural rubber latex residues before putting on gloves or handling medicines or equipment [6].
· If a patient has been prescribed an adrenaline injector, make sure it is available should they need it [1]. Ensure emergency drugs and resuscitation equipment are available – these should also not be made with natural rubber latex [6].
· Make sure they are competent to deal with anaphylaxis or collapse should it occur [6].
· Treat patients with natural rubber latex allergy at the start of the day when allergen levels from treating other patients are lowest [6].
Note: All Septodont dental local anaesthetic prescribing information (summaries of product characteristics) states that their local anaesthetic cartridges have rubber closures. However, the rubber is synthetic and not derived from natural rubber latex. Septodont’s Ultra Safety Plus Dental Single-use syringe system is also not made with natural rubber latex [9].
UKMi Medicines Q&A 331.4 Which dental local anaesthetics are made with natural rubber latex? January 2016
Available through NICE Evidence Search at www.evidence.nhs.uk
Dental local anaesthetic preparations not made with natural rubber latex Natural rubber latex is not used as a material in the manufacture of the following products, their containers and packaging. However, it is not possible to state that a product is ‘free of natural rubber latex’.
Brand name / Ingredients / Presentation / Company / Ref /Articaine
Artikent / Articaine 4% with adrenaline 1:100,000 / 2.2mL cartridge / Kent Express / 9
Bartinest / Articaine 4% with adrenaline 1:100,000 / 2.2mL cartridge / Dental Directory / 9
Espestesin / Articaine 4% with adrenaline 1:100,000 & 1:200,000 / 1.8mL cartridge / 3M ESPE / 10
Isonest / Articaine 4% with adrenaline 1:100,000 / 2.2mL cartridge / Henry Schein / 9
Septanest / Articaine 4% with adrenaline 1:100,000 & 1:200,000 / 2.2mL cartridge / Septodont / 9
Lidocaine
Emla cream$ / Lidocaine 2.5% prilocaine 2.5% / 5g tube (with or without dressings) / AstraZeneca / 11
Eurocaine / Lidocaine 2% with adrenaline 1:80,000 / 2.2mL cartridge / Septodont / 9
Lignokent / Lidocaine 2% with adrenaline 1:80,000 / 2.2mL cartridge / Kent Express / 9
Lignospan Special / Lidocaine 2% with adrenaline 1:80,000 / 1.8 and 2.2mL cartridge / Septodont / 9
Oraqix periodontal gel / Lidocaine 2.5% & prilocaine 2.5% / 25g tube / Dentsply / 12
Rexocaine / Lidocaine 2% with adrenaline 1:80,000 / 2.2mL cartridge / Henry Schein / 9
Utilycaine / Lidocaine 2% with adrenaline 1:80,000 / 2.2mL cartridge / Dental Directory / 9
Xylestein / Lidocaine 2% with adrenaline 1:80,000 / 1.7mL cartridge / 3M ESPE / 10
Xylocaine / Lidocaine 2% with adrenaline 1:80,000 / 2.2mL standard & 2.2mL self-aspirating cartridge / Dentsply / 12
Xylocaine spray / Lidocaine 10mg spray / 50mL bottle / AstraZeneca / 11
Xylonor gel / Lidocaine 5% / 15g tube / Septodont / 9
Xylonor spray / Lidocaine 10% spray / 36g bottle / 9
Mepivacaine
Scandonest Plain / Mepivacaine 3% / 2.2mL cartridge / Septodont / 9
Scandonest Special / Mepivacaine 2% and adrenaline 1:100,000 / 2.2mL cartridge / 9
Prilocaine
Citanest with Octapressin / Prilocaine 3% & felypressin 0.03units/mL / 2.2mL standard & 2.2mL self-aspirating cartridge / Dentsply / 12
$ This is not a dental local anaesthetic but dental professionals may use it for topical anaesthesia prior to procedures such as venepuncture or venous cannulation.
UKMi Medicines Q&A 331.4 Which dental local anaesthetics are made with natural rubber latex? January 2016
Available through NICE Evidence Search at www.evidence.nhs.uk
Limitations
Formulations are subject to change, but information contained in this document is accurate at the time of publication. This document will be updated every two years.
Smith & Nephew were unable to provide information on natural rubber latex content of Ametop gel (tetracaine 4%).
References
1. Anaphylaxis Campaign. Latex allergy: The facts. February 2014. Available at www.anaphylaxis.org.uk/wp-content/uploads/2015/06/Latex-version-6-reformatted-Feb-2014-with-logo-and-AC-update.pdf (accessed 23/12/15).
2. Health and Safety Executive. Latex allergies. Available at www.hse.gov.uk/skin/employ/latex.htm (accessed 23/12/15)
3. Allergy UK. Rubber latex allergy. March 2012. Available at www.allergyuk.org/fs_rubberlatex.aspx (accessed 23/12/15).
4. Health and Safety Executive. Latex allergies in health and social care. Available at www.hse.gov.uk/healthservices/latex/ (accessed 23/12/15)
5. NHS Plus, Royal College of Physicians, Faculty of Occupational Medicine. Latex allergy: occupational aspects of management. A national guideline. London: RCP, 2008. Available at www.hse.gov.uk/healthservices/latex/allergyguide.pdf (accessed 15/12/15).
6. British Dental Association. Hand dermatitis and latex allergy. Fact file. May 2008.
7. European Commission. Medicinal products for human use: safety, environment and information. Excipients in the label and package leaflet of medicinal products for human use. July 2003. Reference 3BC7A. Available at www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003412.pdf (accessed 23/12/15).
8. U.S. Department of Health and Human Services Food and Drug Administration. Recommendations for labeling medical products to inform users that the product or product container is not made with natural rubber latex. Guidance for industry and Food and Drug Administration staff. December 2014. Available at www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm342872.pdf (accessed 23/12/15).
9. Personal communication. Septodont. 15/12/15.
10. Personal communication. 3M ESPE. 15/12/15 & 19/1/16.
11. Personal communication. AstraZeneca. 18/12/15.
12. Personal communication. Dentsply. 16/12/15.
Quality Assurance
Prepared by
Joanne McEntee. Medicines Information Pharmacist.
North West Medicines Information Centre, 70 Pembroke Place, Liverpool, L69 3GF.
Date Prepared
December 2015 and January 2016
Checked by
Christine Randall (Senior Medicines Information Pharmacist).
North West Medicines Information Centre, 70 Pembroke Place, Liverpool, L69 3GF.
Date of check
January 2016
Search strategy (completed Dec 2015)
¨ Embase via NICE Evidence Search ([*LATEX/] and [exp LOCAL ANESTHETIC AGENT/).
¨ Medline via NICE Evidence Search ([LATEX/ or LATEX HYPERSENSITIVITY/] and [exp ANESTHETICS, LOCAL/ or EPINEPHRINE/ or FELYPRESSIN/]).
¨ In-house database/resources.
¨ NICE Evidence Search www.evidence.nhs.uk (free text [latex allergy]).
¨ Latex Allergy Support Association www.lasg.org.uk
(LASG merged with the Anaphylaxis Campaign on 1/1/16)
¨ Anaphylaxis Campaign www.anaphylaxis.org.uk
¨ Allergy UK www.allergyuk.org
¨ British Association of Dermatologists www.bad.org.uk
¨ National Patient Safety Agency www.npsa.nhs.uk (legacy site)
¨ Health and Safety Executive www.hse.gov.uk (free text [latex]).
¨ Medicines and Healthcare products Regulatory Agency www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
¨ European Medicines Agency www.ema.europa.eu
¨ Food and Drug Administration www.fda.gov
¨ Pharmaceutical manufacturers’ websites and medical information departments
External reviewers (January 2012)
¨ Ms Ann Clarke. Honorary Secretary, Latex Allergy Support Group.
¨ Dr Tina Dixon. Consultant Allergist, Royal Liverpool and Broadgreen Hospital.
¨ Dr Anne Field. Clinical Director and Consultant/Honorary Professor in Oral Medicine, Liverpool University Dental Hospital.
¨ Dr Lesley Longman, Senior Lecturer/Honorary Consultant in Special Care & Restorative Dentistry, & Clinical Teaching Lead for Sedation and Special Care Dentistry, School of Dental Sciences, Liverpool.
¨ Dr Mike Pemberton. Consultant in Oral Medicine, University Dental Hospital of Manchester.
¨ Dr Gavin Spickett. Consultant Clinical Immunologist, Royal Victoria Infirmary, Newcastle.
¨ Catherine Stephenson, Medicines Information Manager, Nottingham University Hospitals NHS Trust.
UKMi Medicines Q&A 331.4 Which dental local anaesthetics are made with natural rubber latex? January 2016
Available through NICE Evidence Search at www.evidence.nhs.uk