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Verrucae, Stop messing about

Discussion in 'General Issues and Discussion Forum' started by wdd, Jun 28, 2013.

  1. wdd

    wdd Well-Known Member

    Members do not see these Ads. Sign Up.
    Acids, Freezing, Needling. If you want to do something that works and causes no pain and is undoubtedly the way things are going why not use 5-Flourouracil.

    I am attaching a few abstracts associated with the use of 5-Flourouracil in the treatment of verrucae.

    Having also seen at first hand the effects of 5-Flourouracil on resitant verrucae and the total lack of discomfot for the patient I will never again mess about with acids, freezing, needling or any treatment that causes damage to the tissues and I most certainly wouldn't invest in any expensive equipment.

    The podiatrist main function in the management of Verrucae using 5-Flourouracil is to debride any keratinous barrier so that the drug can reach the living cells.

    Pediatr Dermatol. 2009 May-Jun;26(3):279-85. doi: 10.1111/j.1525-1470.2008.00800.x.
    5% 5-Fluorouracil cream for treatment of verruca vulgaris in children.
    Gladsjo JA, Alió Sáenz AB, Bergman J, Kricorian G, Cunningham BB.
    University of California, San Diego, California, USA.
    Warts are a common pediatric skin disease. Most treatments show only modest benefit, and some are poorly tolerated because of pain. 5-fluorouracil interferes with deoxyribonucleic acid and ribonucleic acid synthesis, and is used to treat genital warts in adults. Efficacy, safety, and tolerability of topical 5% 5-fluorouracil for treatment of common warts were examined in an open-label pilot study with pediatric patients. Thirty-nine children who have at least two hand warts applied 5% 5-fluorouracil cream (Efudex, Valeant Pharmaceuticals International) once or twice daily, under occlusion for 6 weeks. Assessment of treatment response and side effects was performed at baseline, treatment completion, and 3- and 6-month follow-ups. Hematology measures, liver function tests, and medication blood levels were reassessed at treatment completion. Eighty-eight percent of treated warts improved after 6 weeks of treatment, and 41% of subjects had complete resolution of at least one wart. Treatment response did not differ between once or twice daily applications. Tolerability and patient satisfaction were excellent. No subject had clinically significant blood levels of 5-fluorouracil. At 6 month follow-up, 87% of complete responders had no wart recurrence. Topical 5% 5-fluorouracil is a safe, effective, and well-tolerated treatment for warts in children.
    PMID: 19706088 [PubMed - indexed for MEDLINE]
    Publication Types, MeSH Terms, Substances
    LinkOut - more resources

    Dermatologica. 1980;160(6):383-9.
    Treatment of verruca plana with 5% 5-fluorouracil ointment.
    Lee S, Kim JG, Chun SI.
    11 patients with verruca plana were treated with 5% 5-Fluorouracil ointment as a twice daily topical application with open dressing. The patients were chosen among those who failed to be cured with avrious topical agents such as salicylic acid, vitamin A acid and dinitrochlorobenzene (DNCB), or even with carbon dioxide cryotherapy, oral administration of methotrexate and intramuscular injection of sodium cacodylate. In 9 patients, all the treated warts completely disappeared within 3--5 weeks. 2 of these patients had recurrence after 3 weeks and 2 months, respectively. In 2 patients, some lesions disppeared while others failed to be healed. The major clinical adverse reactions were hyperpigmentation (8 cases), erythema (5 cases) and erosion (5 cases).
    PMID: 7389971 [PubMed - indexed for MEDLINE]
    MeSH Terms, Substances
    LinkOut - more resources

    Intralesional 5-fluorouracil, lidocaine and epinephrine mixture for the treatment of verrucae: a prospective placebo-controlled, single-blind randomized study.
    Isçimen A, Aydemir EH, Göksügür N, Engin B.
    Cerrahpasa Medical Faculty, Dermatology Department, University of Istanbul, TR-34303 Aksaray, Istanbul, Turkey.
    The treatment of viral warts remains challenging. A variety of treatment modalities have been used with a range of success. Fluorouracil has been shown to be effective in treating warts but the method of its delivery directly onto the affected tissue has been of little efficacy. We evaluated the safety and efficacy of intralesional 5-fluorouracil in the treatment of verrucae.
    Seventy-six patients with a total 315 verrucae were randomized to receive either a 5-fluorouracil, lidocaine and epinephrine (5-FU + LE) mixture or serum saline injection into the paired verrucae in the same patient. The mixture of 5-FU (4 cm(3), 50 mg/mL), lidocaine (1 cm(3), 20 mg/mL) and epinephrine (0.0125 mg/mL) was injected into the base of the wart using a mantoux needle. Each lesion was infiltrated with either of the solutions once a week for up to a maximum of 4 weeks, and the patients were followed up for 6 months.
    Complete response was noted in an average of 70% of the verrucae treated with the 5-FU + LE mixture and in 29% of those in the placebo group (P < 0.001). No clinically significant systemic and local adverse effects occurred. Pain and burning were noted as an immediate injection pain. Recurrence rates were evaluated and no statistically significant difference between the two groups was found.
    The results demonstrate that treatment of verrucae with 5-FU + LE mixture is safe and effective.
    PMID: 15196161 [PubMed - indexed for MEDLINE]
    Publication Types, MeSH Terms, Substances
    LinkOut - more resources
    Plantar Warts/Warts
    The primary objective of a current multicenter, randomized controlled trial conducted by the Department of Health Sciences, University of York, UK is to compare the clinical effectiveness of two common treatments for verrucae: cryotherapy using liquid nitrogen versus salicylic acid. The primary outcome is complete clearance of all verrucae as observed on digital photographs taken at 12 weeks.

    The EVERT (effective verruca treatments) trial protocol: a randomised controlled trial to evaluate cryotherapy versus salicylic acid for the treatment of verrucae
    E Sarah Cockayne and The EVERT Trial Team

    Accessed May 9, 2011

    Topical 5-fluorouracil (5-FU) 5% with tape occlusion produced complete eradication of all plantar warts within 12 weeks of treatment in 19 of 20 patients. It was concluded that use of topical 5% 5-fluorouracil cream for plantar warts is safe, efficacious, and accepted by the patient.

    J Drugs Dermatol. 2006 May;5(5):418-24.
    Topical 5% 5-fluorouracil cream in the treatment of plantar warts: a prospective, randomized, and controlled clinical study.
    Click here to access the PubMed abstract of this article.

    A medical record review was conducted by the Podiatry Division, Department of Orthopedics, Cabrini Medical Center, New York, NY to determine the clinical outcome and average time to resolution of verruca plantaris (plantar warts) in 20 patients treated with twice-daily applications of topical fluorouracil (5-FU) combined with topical 17% and 40% salicylic acid. Twice-daily application of topical fluorouracil and salicylic acid is a safe and effective treatment for verruca plantaris.

    J Am Podiatr Med Assoc. 2005 Jul-Aug;95(4):366-9.
    Treatment of verruca plantaris with a combination of topical fluorouracil and salicylic acid.
  2. Each to their own. Here are the contraindications of 5-Fluorouracil:

    No thank you. I'll stick to needling.
  3. blinda

    blinda MVP

    Sorry Bill, I just don`t get this statement. I understand that keratin is the cytoskeleton of epithelial tissue and that proliferation/overproduction of prickle cells are induced from the spinosum and granulosum layers as the virus replicates, so this epidermal tissue requires reduction prior to tx....but which "living cells" are you alluding to? Is it the basal layer where the viral particles lay dormant as it incubates for many months?

    Interesting studies but I`m afraid you`ll be hard pressed to persuade a GP to write a script for this, along with topical Aldera and all the other inflammatory modifiers, such as Imiquimod, Adapalene, etc which have certainly been seen to promote HPV resolution in certain sub-types, but can only be used off label for verrucae as they have not been approved for podiatric use. At least in the UK....that and the nasty side effects as pertinently highlighted by Kevin.

    That said, I`m not dissing 5-Flourouracil. I`m open minded where dermo is concerned. Where do you practice?

    PS. Needling doesn`t `cause pain`;)

    Last edited: Jun 28, 2013
  4. wdd

    wdd Well-Known Member

  5. ElijahPerez

    ElijahPerez Welcome New Poster

    Thanks for sharing detailed information.. Was the test successful and is it useful?Waiting for reply thanks in advance:)
  6. wdd

    wdd Well-Known Member


    The complete literature review, from which the following abstract was taken starts on page 57 of the above. Enjoy.


    Efficacy of Topical Agents (SA, 5-FU, and
    IMQ) for Treatment of
    Verruca Plantaris: A Systematic Review
    Aaron Bradley, BS, Danielle Boyle, BS, and Michael Rossidis, BS
    Conventional treatments for Verruca Plantaris are often challenging and painful being that these
    modalities obliterate infected keratinocytes by chemical or physical destruction. A literature
    review was conducted to assess and evaluate the efficacy of topical agents, specifically Salicylic
    Acid (SA), 5-Flurouracil (5-FU), and Imiquoid (IMQ), on the treatment of Verruca Plantaris
    Study Design
    Qualitative Systematic Review of the Literature
    An English language literature search was conducted using the PubMed, Cochrane databases, and
    a review of textbook articles. Studies which contained HIV + or immunocompromised subjects or
    subjects who were prescribed immunosuppressants were excluded from this review. Other
    exclusions included non-English articles or articles published prior to 2000. Inclusion criteria
    consists of adults and children, HIV– and immunocompetent patients, and terms “Verruca
    Plantaris” OR “Plantar Warts.”
    Ten articles were obtained through the PubMed and Cochrane database that met the criteria for
    the study.
    Treatment of VP was enhanced when the regimen included topical agents, such as 5-FU and IMQ,
    coupled with a keratinolytic agent, such as SA. These novel topical agents were able to decrease
    clearance time, when compared to conventional treatments, and were found to be most effective
    when coupled together. Future randomized controlled trials comparing the efficacy of 5FU/SA
    and imiquimod/SA on the treatment of recurrent plantar warts should take into account a
    standardized time frame of sustained clearance and potential adverse side effects. Moreover, such
    future studies may assist practitioners in determining the proper treatment for each individual
    Key Words
    Verruca, 5-FU, IMQ
    Level of Evidence: 4
  7. Leah Claydon

    Leah Claydon Active Member

    There was a good article in Podiatry Now about using Efudex in about 2006 - I was practicing in Cyprus at the time and without the prescription laws it was easy to get hold of, although massively expensive - around £45 for a tiny tube. I found it worked well, was well tolerated and popular with patients. I have tried to get GPs to prescribe it here in the UK but they are not happy to do so - most like on grounds of cost.
  8. wdd

    wdd Well-Known Member

  9. Leah Claydon

    Leah Claydon Active Member

    Happy to expand. Amongst many other cases, 2 in particular stick in my mind.

    1. 60+ yr old woman. Had previously presented in UK to a podiatrist with a lesion on her RF sub 2nd MTPJ. It had been treated as a neuro-vasc corn without resolution. The previous Pod thought it was due to transference pressure secondary to HAV. The patient was referred to have surgical removal of the 'nv' corn and the surgeon decided she should have HAV correction to prevent reccurence. The poor woman acquired a post op MRSA infection which resulted in a 6 month stay in hospital because of non-union due to osteomyelitis. I saw her some 3 years post-op and guess what - the 'nv' corn was still there! The lesion didn't really present as a typical nv corn and I suspected it was a VP - amazing it was still there after deep curretage. This lesion responded to twice daily applications of Efudex under Tegaderm to keep it in place and aid absorption. The lesion cleared painlessly and without complication in 4 weeks. She remained a patient for many years and the lesion did not recur.

    2. A podiatrist colleague of mine in Cyprus (female aged 48), had multiple mosaic warts bubbling up around most of her finger nails which looked unsightly and were of obvious great embarrassment given our profession. She had tried every VP treatment in our tool box for 7 years + and nothing had worked. I suggested Efudex under Sleek twice daily and they cleared within a month never to return.

    Of course these are just two anecdotal histories, but I can report that of the say 25 patients that opted for Efudex, I did not receive any reports of irritation or other adverse reaction. It is a POM for good reason, but it is shame access to it so restricted. It is my belief that it is not licensed in the UK for use on warts - I think the nearest product to it in the UK is Bleomycin - which is usually administered in Dermatology clinics by Dermajet injection.
  10. wdd

    wdd Well-Known Member

    The following was taken from an article appearing in 2004.

    In the article they say that they were currently undertaking a controlled randomised trial using Efudex cream. Does anyone know the outcome of that study?

    Exploring Alternative Treatment For Resistant Warts - See more at: http://www.podiatrytoday.com/article/2598?page=2#sthash.H9ouXO8e.dpuf

    [Issue Number:
    Volume 17 - Issue 5 - May 2004B][/B]

    By Robert Salk, DPM, Kirk Grogan, DPM, Thomas Chang, DPM, and Walter D’Costa, DPM

    5-fluorouracil (Efudex, Carac Cream). One may utilize 5-fluorouracil as a cream with two existing forms, Efudex 5% cream and Carac 0.5% cream. The agent 5-fluorouracil is chemotherapeutic and is FDA-approved for actinic keratoses and basal cell carcinomas. However, there has been a great deal of interest in its off-label use for the HPV virus. We typically use Efudex in our treatment course for warts as it is has 10 times the strength of Carac cream. However, Carac cream is known to supply the 5-fluorouracil over an extended period of time.
    While the exact mechanism is unknown, this agent does inhibit DNA synthesis.2 By inhibiting DNA synthesis with 5-fluorouracil, we eradicate the wart because the wart is a DNA virus. We are currently conducting a controlled randomized trial with the use of Efudex cream. Prior to the study, we have utilized 5-fluorouracil as a first-line treatment for plantar warts with excellent success. In the clinic, you would apply the medication to the debrided lesion and occlude it with tape. This treatment course is simple both for the clinician and patient. If pinpoint bleeding occurs with debridement, you must establish hemostasis before applying 5-fluorouracil and tape (waterproof tape, duct tape). The choice of tape is open as long as it has strong adhesive properties and is waterproof. In order to maintain a high concentration of the 5-fluorouracil for the wart, emphasize to the patient that he or she should apply it twice a day and perform debridement with a pumice stone at home. It is extremely important to see the patient every one or two weeks in the clinic in order to pare nonviable tissue. Doing so allows maximum contact and penetration of the medication to the wart. Since 5-fluorouracil has the tendency to affect the wart exclusively, there is not as much of an issue of containing the medicine. Unlike salicylic acid, 5-fluorouracil has great affinity to the wart without affecting surrounding tissues. Many patients will have extensive maceration of the warts within two weeks. As the weeks go by and with diligent treatment at home, the wart will actually begin to ulcerate. This is normal as the wart is simply destroyed at a faster rate than it can be replaced with healthy skin. These ulcerations are superficial, minimally painful and are harbingers of complete destruction of the wart. When you can see skin lines running right to the edge of the ulcer, have the patient continue the treatment for one to two more weeks. At the end of this period, follow up with the patient, discontinue the 5-fluorouracil and allow the lesion to heal. The typical treatment course for 5-fluorouracil will be from eight to 10 weeks. - See more at: http://www.podiatrytoday.com/article/2598?page=2#sthash.TAWote31.dpuf
  11. Tkemp

    Tkemp Active Member

    So from 11 patients, 7 experienced complete resolution of the problem.
    However, 8 out of 11 (72.73%) had a "major clinical adverse reaction"
    and 2 other "major clinical reactions" were both experienced by 5 out of 11 (45.45%).

    I personally am not convinced the benefits outweigh the risks.
    Thank you for the information and research though.
  12. wdd

    wdd Well-Known Member

    I personally am not convinced the benefits outweigh the risks.

    That undoubtedly gets to the root of the issue. In a general sense what are the risks? Not a list of the things that might happen (as highlighted by Kevin, earlier in this thread) but a list of the probabiities of particular adverse reactions. Surely 5-flourouracil has been used both with sufficient frequency and over a long enough period of time to be able to come up with a list of the levels of probability of specific adverse outcomes?

    Time for a little search online.

  13. wdd

    wdd Well-Known Member

    The following was taken from this web site. It refers only to the topical use of Efudix over a recommended maximum skin surface area of 500 square centimetres.

    '4.8 Undesirable side effects' gives some sense of the probability of adverse reaction within system organ classes

    http://www.medicines.org.uk/emc/medicine/6219/SPC/Efudix Cream

    4.1 Therapeutic indications
    Efudix is used for the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenical forms; keratoacanthoma; Bowen's disease; superficial basal-cell carcinoma. Deep, penetrating or nodular basal cell and squamous cell carcinomas do not usually respond to Efudix therapy. It should be used only as a palliative therapy in such cases where no other form of treatment is possible.
    4.2 Posology and method of administration
    Efudix cream is for topical application.
    Pre-malignant conditions
    The cream should be applied thinly to the affected area once or twice daily; an occlusive dressing is not essential.
    Malignant conditions
    The cream should be applied once or twice daily under an occlusive dressing where this is practicable.
    The cream should not harm healthy skin. Treatment should be continued until there is marked inflammatory response from the treated area, preferably with some erosion in the case of pre-malignant conditions. Severe discomfort may be alleviated by the use of topical steroid cream. The usual duration of treatment for an initial course of therapy is three to four weeks, but this may be prolonged. Lesions on the face usually respond more quickly than those on the trunk or lower limbs whilst lesions on the hands and forearms respond more slowly. Healing may not be complete until one or two months after therapy is stopped.
    Many of the conditions for which Efudix is indicated are common in the elderly. No special precautions are necessary.
    In view of the lack of clinical data available, Efudix is not recommended for use in children.
    4.3 Contraindications
    Efudix is contraindicated in patients with known hypersensitivity to fluorouracil or any of the excipients in Efudix Cream.
    Coadministration of Efudix with antiviral nucleoside drugs (e.g. brivudine and analogues) may lead to a substantial increase in plasma levels of fluorouracil and associated toxicity and is contraindicated. Brivudine and analogues are potent inhibitors of DPD, a fluorouracil metabolising enzyme (see section 4.4 and 4.5)
    Use of Efudix during pregnancy and in breast-feeding mothers is contraindicated.
    4.4 Special warnings and precautions for use
    The hands should be washed carefully after applying Efudix. Also care should be taken to avoid contact with mucous membranes or the eyes when applying the cream.
    The total area of skin being treated with Efudix at any one time should not exceed 500 cm2 (approximately 23 x 23 cm). Larger areas should be treated a section at a time.
    The normal pattern of response includes: early and severe inflammatory phases (typically characterised by erythema, which may become intense and blotchy), a necrotic phase (characterised by skin erosion) and finally healing (when epithelialisation occurs). The clinical manifestation of response usually occurs in the second week of Efudix treatment. However these treatment effects sometimes be more severe and include pain, blistering and ulceration (see section 4.8). Exposure to sunlight may increase the intensity of the reaction.
    Pre-existing subclinical lesions may become apparent following Efudix use.
    Any severe skin discomfort during treatment with Efudix may be alleviated by the use of an appropriate topical steroid cream.
    When used according to the approved prescribing information Efudix should have minimal effect on healthy skin.
    Significant systemic drug toxicity is unlikely via percutaneous absorption of fluorouracil when Efudix is administered as per the approved prescribing information. However the likelihood of this is increased if the product is used excessively, especially on skin areas in which the barrier function is impaired (e.g. cuts) and/or in individuals with deficiency in dihydropyrimidine dehydrogenase (DPD), see section 4.8. DPD is a key enzyme involved in metabolising and eliminating fluorouracil. Determination of DPD activity may be considered where systemic drug toxicity is confirmed or suspected. There have been reports of increased toxicity in patients who have reduced activity/deficiency of the enzyme dihydropyrimidine dehydrogenase. In the event of suspected systemic drug toxicity, consideration should be given to stopping Efudix treatment.
    An interval of at least four weeks should elapse between treatment with brivudine, sorivudine or analogues and subsequent administration of Efudix.
    The excipients stearyl alcohol and propylene glycol may cause local skin irritations (e.g. contact dermatitis); the excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
    4.5 Interaction with other medicinal products and other forms of interaction
    Although no significant drug interactions with Efudix have been reported, potential drug interactions are possible as indicated below.
    Brivudine, sorivudine and analogues are potent inhibitors of DPD, a fluorouracil metabolising enzyme (see section 4.4). For this reason, concomitant administration of these drugs with Efudix is contraindicated (see section 4.3)
    4.6 Pregnancy and lactation
    There are no adequate data from the use of fluorouracil in pregnant women.
    Studies in animals have shown that fluorouracil is teratogenic (see section 5.3). The potential risk for humans is unknown, hence Efudix should not be used during pregnancy and in nursing mothers (see section 4.3)
    4.7 Effects on ability to drive and use machines
    None known.
    4.8 Undesirable effects
    Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories:
    Very common (> 1/10) Common (> 1/100 to <1/10) Uncommon (> 1/1,000 to <1/100) Rare (> 1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data)
    Adverse reactions associated with exacerbations of normal pattern of response (see section 4.4) which are related to pharmacological activity of fluorouracil on the skin are the most frequently reported reactions. Allergic type skin reactions and reactions related to systemic drug toxicity are very rarely reported.
    Immune system disorders
    Very rare: Allergic conditions (e.g. hypersensitivity and allergic reactions).
    Nervous system disorders
    Frequency not known: Dysgeusia.
    Eye disorders
    Frequency not known: Conjunctival irritation, keratitis, increased lacrimation.
    Skin and subcutaneous tissue disorders
    Very rare: Pruritus, urticaria, rash (usually local but also generalised if associated with systemic drug toxicity); erythemas including erythema multiforme; dermal and epidermal conditions (such as skin burning sensation, skin exfoliation, skin swelling); skin and subcutaneous skin ulcerations; dermatitis and eczema conditions (such as contact dermatitis, skin irritation); blisters, and alopecia.
    Exposure to sunlight may increase the intensity of the reaction.
    See also normal pattern of response in section 4.4
    General disorders and administration site conditions
    Application and installation site reactions (localised skin reactions associated with use of Efudix; see also under skin and subcutaneous disorders), pain.
    The following undesirable effects are associated with systemic drug toxicity (see section 4.4)
    Blood and lymphatic system disorders
    Very rare: Haematological disorders, associated with systemic drug toxicity, e.g. pancytopenia, neutropenia, thrombocytopenia.
    Gastrointestinal disorders
    Very rare: Diarrhoea haemorrhagic, diarrhoea, vomiting, abdominal pain, stomatitis, associated with systemic drug toxicity.
    General disorders and administration site conditions
    Very rare: Pyrexia, chills and mucosal inflammation, associated with systemic drug toxicity.
    Reporting of suspected adverse reactions
    Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
  14. wdd

    wdd Well-Known Member

    Did the research define "major clinical reaction"?

  15. Tkemp

    Tkemp Active Member

    Hyperpigmentation, erythema, erosion
  16. wdd

    wdd Well-Known Member

    Thanks for the info.

    Hyperpigmentation, erythema and erosion seem to be part of the normal response (see below) or an exaggeration of the normal response and of course depending upon the degree of the response and the frequency of the response might be considered as 'major clinical reactions'. However from the data,collected by eMC (which should include the adverse reactions included in the study you cite) such responses are classified as very rare, ie occurring in <1/10,000 patients.

    However 8 out of 11 patients presenting with hyperpigmentation, erythema, erosion, ulceration swelling, pain would seem to correspond pretty well with my experience of traditional podiatric verruca treatments in fact I think it would be nearer 11 out of 11 cases.

    "I am not convinced that the benefits outweigh the risks". For my money the accumulating evidence seems to me to suggest that the benefits massively outweigh the risks.

    (from eMC website)

    The normal pattern of response includes: early and severe inflammatory phases (typically characterised by erythema, which may become intense and blotchy), a necrotic phase (characterised by skin erosion) and finally healing (when epithelialisation occurs). The clinical manifestation of response usually occurs in the second week of Efudix treatment. However these treatment effects sometimes be more severe and include pain, blistering and ulceration (see section 4.8). Exposure to sunlight may increase the intensity of the reaction.
    Pre-existing subclinical lesions may become apparent following Efudix use.

    Any severe skin discomfort during treatment with Efudix may be alleviated by the use of an appropriate topical steroid cream.

    When used according to the approved prescribing information Efudix should have minimal effect on healthy skin.

  17. Lawrence Bevan

    Lawrence Bevan Active Member


    The info on the eMC website will relate to expected reactions when the product is used in licensed use. Use on verrucae is off-license.

    The specific indications on the product summary are "Efudix is used for the topical treatment of superficial pre-malignant and malignant skin lesions"

    The adverse effects mentioned may not be the same as those experienced when a product is used off-license. This is not to say they will be different but legally you cannot refer to the adverse effects in the license as a defense if an unexpected adverse reaction is encountered from off-license use.

    For instance will hyperkeratosis impact on absorption, will weight bearing - in the same manner Sal acid can be??

    This is not to say that I think this is a bad idea - its probably a very good one, just thought I would chip in!

    Good discussion

  18. wdd

    wdd Well-Known Member

    They seem like good points to me Lawrence.

    Something I don't know but someone may is, if an organisation such as eMC wishes to be informed of adverse reactions does it only wish to be informed of those adverse reactions resulting from 'licenced' use and associated with that, when someone informs them of an adverse reaction will the information supplied include the condition that it was being used to treat? I imagine that for 'off licence' use to possibly, one day become 'licenced', reporting and recording 'off licence' adverse reactions would be a very valuable way of accumulating evidence.

  19. Lawrence Bevan

    Lawrence Bevan Active Member

    Thats another good point - the MHRA are the UK regulatory body that will monitor and compile the reported adverse reactions. I think they only do so for the product in its licensed use. Unlicensed use in some senses can be considered mis-use and an adverse reaction from mis-use is not an adverse reaction but simply mis-use.

    Applications for license are based on economics - it takes about 10 years and millions of pounds so often a product is not re-licensed but a popular off-license can become more common than the licensed use. A good example is Amytriptaline now not used for depression (licensed use) but is used for neuro pain - unlicensed. The BNF can specify dosages for the unlicensed use but will state if it is unlicensed.

    All based on custom and practice - and where published research is very helpful

    Grey area as they say.
  20. wdd

    wdd Well-Known Member

  21. wdd

    wdd Well-Known Member

    Wartpeel. Is apparently designed for the treatment of verrucae and contains 5 flourouracil and sal. acid.

    The sal. acid is designed to take the place of the podiatrist by debriding the verruca to allow penetration of the 5 flourouracil.

    It seems that many of the above comments re risks associated with the use of 5 flourouracil in the management of verrucae are being overtaken by events?

    Personally I would rather use 5 flourouracil with regular and frequent podiatric debridement to allow penetration of the 5 flourouracil than any other treatment both for comfort, ease of application, risk and efficacy.

    But maybe I am wrong. Time will tell.

  22. ives

    ives Member

  23. wdd

    wdd Well-Known Member

    Adapalene looks very promising. Is its off licence use for the management of verrucae becoming more common and if not why not?

    I certainly get the feeling that we are on the verge of a revoution in terms of treatment of verruca, ie away from treatments producing chemical, thermal or mechanical musherisation of tissues, including the verruca or at least some part of it and towards treatments minimising or eliminating tissue trauma, pain and discomfort (including psychological pain and discomfort and sense of hoplessness for the teating podiatrist) and with a cure rate approaching 100% within a thirty day period.

    Hopefully the introduction of independent prescriber courses for podiatrists in the UK will eventually lead to, a well reasoned and researched increase in the appropriate use of such drugs at least in the UK.

  24. Rob Kidd

    Rob Kidd Well-Known Member

    The above does beg the question: why are you treating at all? In the case of asymptomatic warts, why not simply leave them alone? Symtpomatic - well that is a different story
  25. wdd

    wdd Well-Known Member

    Good question Robb.

    I wonder what percentage of veruccae are asymptomatic and possibly more relevant to the podiatrist, what percentage of verrucae seen by the podiatrist are asymptomatic?

    Sounds like a nice and easy, inexpensive research project I wonder if it has already been done?

    Of course the definition of 'symptom' in the case of verrucae includes the presence of a verruca so I suppose that in a sense all verrucae are symptomatic. That's a bit too slippery but if the verruca is causing either the patient or their parent/s/carer mental anguish would that make the verruca sufficiently symptomatic to treat?

    One of the reasons proposed for treating asymptomatic verrucae that I remember from student days was that without treatment the verrucae might increase in number. Treating in a case where the verrucae are multiplying always seemed like a hiding to nothing to me.

    A slight aside - how is recalcitrant defined?

  26. blinda

    blinda MVP

    Indeed. My favourite (stolen from Rob`s aunt, I think?) treatment for verrucae is a `tincture of time`.

    I would define symptomatic as those lesions which interfere with the patients quality of life - in either a painful or psychological manner.
  27. wdd

    wdd Well-Known Member

    That would mean that almost 100% of verrucae could be classified as symptomatic?

  28. blinda

    blinda MVP

    Not really. Many pts who seek treatment for a different pathology are often surprised to discover that they have a VP as they have never noticed it. I will briefly explain the aetiology of HPV and most are happy to just leave it alone. Nowadays, I actually get more satisfaction with educating people on the nature of the virus, than treating them!
  29. Simon Ross

    Simon Ross Active Member

    "I actually get more satisfaction with educating people on the nature of the virus, than treating them"

    Bel, that is one excellent comment. One of the best that I have ever read!

    There are too many practitioners out there, who seem quite happy to continue to treat VPs once every 2 weeks, do not review the treatment outcome, and are only too happy to take money of the customer!
  30. Rob Kidd

    Rob Kidd Well-Known Member

    My Gran actually, but I will let you off on this one occassian. I cannot seem to spell occassion tonight). When she died in 1986; she had practised medicine from Qual in 1924 (I have her final year papers framed in acid proof in my office, behind my head as I speak), until she was 80, in 1981. The obtuse cases she told me about were the siamese twins (mentioned in an earlier post). But there was also the guy with an amputated penis - she had it reattached. Whether it worked afterwards- no idea. But what she did do, was to neither give nor take any ****. She advised me on the best way to diagnose diptheria; "you get their gob wide open (a Northern lass), get your nose down and smell. you will sense the difference between an ordinary strep and diptheria straight away. This level of perception, observation etc has been lost in our diagnosese of today - maybe that is right. If anyone is interested, I will photo her final years papers from Queens in Belfast, and publish them. Be quite clear, I am not pushing my own - I am simply looking at history and how important it is.
  31. wdd

    wdd Well-Known Member

    Dear Bel.,

    Of course the group who didn't know that they had verrucae are unlikely to have been troubled psychologically by their presence but I would love to know how the group who have discovered that they have verruca respond longer term.

    Like work expanding to fill the time available for its completion I think a similar principle applies to worry/concern/psychological symptoms. Humans have a need to worry about things. Of course that need varies from person but there is no one who does not worry about something. If there are no major worries and often even if there are they will focus on the small things, like a physically symptom free verruca.

    If your patients found that your explanation relieved them of any future concern re their verruca I would think you have identified a very select group of people. For many I would expect it to eat away at them until eventually they would either start to pick at it physically or psychologically and ultimately become so uncomfortable about it that they would feel forced to do something about it.

    Best wishes,


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