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Erica L Eason, SM, MDCM, FRCSC; Perle Feldman, BSc, MDCM, CCFP

Objective: To report a clinical association between vulvar irritation or contact dermatitis and the use of Always sanitary napkins. Design: Case series. Setting: A gynecology practice in Montreal. Patients: Women presenting between September 1991 and September 1994 with itching or burning of areas that would be in contact with a sanitary napkin (mons pubis, external surfaces of the vulva and perineum) beginning at least 1 day after the use of the napkins was started and less than 5 days after the use was stopped. Results: Twenty-eight women experienced vulvar itching and burning, often associated with eruptions resembling contact dermatitis, of the vulvar and perineal surfaces after using Always sanitary napkins. Twenty-six reported that symptoms disappeared after they stopped using that brand of sanitary napkin. Seven women who later used the same brand again reported a recurrence of the vulvar irritation. Conclusion: The findings of this case series reveal Always sanitary napkins as a potentially important cause of recurrent vulvitis. Physician awareness of the association will enable effective advice and relief for a large number of women suffering "chronic vaginitis."

Objectif: Signaler lexistence d'un lien clinique entre lirritation vulvaire ou la dermatite de contact et lutilisation de serviettes sanitaires Always. Conception Serie de cas. Contexte Pratique gynecologique de Montreal. Patientes: Femmes qui se sont presentees 'a la clinique entre septembre 1991 et septembre 1994 avec des demangeaisons ou des br'ulures aux endroits en contact avec une serviette sanitaire (mont de Venus, surfaces externes de la vulve et perinee), problemes qui ont fait leur apparition au moins 1 jour apres qu'elles aient commence 'a porter les serviettes et moins de 5 jours apres qu'elles aient cesse den porter. Resultats Vingt-huit femmes ont eu des demangeaisons et des br'ulures vulvaires, souvent liees 'a des eruptions ressemblant 'a celles qui sont causees par une dermatite de contact, des surfaces vulvaires et perineales apres avoir porte des serviettes sanitaires Always. Vingt-six ont signale que les symptomes sont disparus apres qu'elles aient cesse de porter cette marque de serviette sanitaire. Sept femmes qui ont reutilise plus tard la meme marque ont signale que lirritation vulvaire etait reapparue. Conclusion Les resultats de cette serie de cas revelent que les serviettes sanitaires Always peuvent etre une cause importante de vulvite 'a repetition. La sensibilisation des medecins a ce lien leur permettra de conseiller efficacement et de soulager beaucoup de femmes souffrant de <(vaginite chronique>>.

S ome years ago each of us observed several patients who presented with similar and unusual histories. These women complained of "vaginal infections" every month, but our clinical and microscopic examinations revealed no evidence of vaginitis. Some of the women

had received repeated treatments elsewhere with antifungal medications, without a decrease in recurrence of symptoms. All of the women had itching or burning of the mons pubis, labia and perineum but no associated odour or vaginal discharge and no redness or swelling of

Dr. Eason is assistant professor in the departments of Obstetrics and Gynecology and of Clinical Epidemiology, Montreal General Hospital and McGill University, Montreal, Que.; and Dr. Feldman is assistant professor in the Department of Family Medicine, Sir Mortimer 8. Davis-Jewish General Hospital and McGill University, Montreal, Que.

Reprint requests to: Dr. Erica L. Eason, Rm. L10-412, Montreal General Hospital, 1650 CedarAve., Montreal QC H3G 1A4
0 1996 Canadian Medical Association

(text and abstract/resume)

CAN MED ASSOC J * APR. 15, 1996; 154 (8)


the inner labia and vestibule. Symptoms subsided after several days, with or without treatment. In some cases we noted an erythematous papular eruption over the groin, mons pubis and perineum. We suspected contact dermatitis rather than the much more common vulvovaginitis due to Candida albicans, Tricbomonas or bacteria.,,2 However, questioning about the usual suspects --exposure to perfumes or deodorants, detergents and fabric softeners, or a change in soap-'3 - revealed no obvious cause. Two clues alerted us to a connection between the symptoms and the use of sanitary napkins. First, in some of the women the sharp margins of the eruption outlined the contact area of a sanitary napkin. In parous women the clitoral hood and the tips of the labia minora extending beyond the labia majora were often most severely affected. Second, the symptoms started during or a few days after menses; microbial vaginitis usually presents in the premenstrual period and is somewhat relieved during menses. When questioned about the brand of tampons or sanitary napkins they used, the women gave us the same answer: Always sanitary napkins (Procter & Gamble Inc., Toronto). Changing the brand, without specific treatment of the irritation, prevented recurrence of the symptoms. We have not seen this periodic menstrual vulvitis in women using other brands of sanitary napkins. The US Food and Drug Administration (FDA) has received a few reports of similar adverse reactions to Always sanitary napkins (FDA, Washington: Medical Device Report [list edition], June 1993). Our search of the medical literature revealed two cases.of allergy to the perfume used in sanitary napkins45 but no reports of contact dermatitis or irritation associated with any particular brand. When asked, most of our colleagues had not noticed this association; however, those who had recognized it had seen it several times, and others reported cases to us after we alerted them to it. To document this problem and to inform physicians of the diagnosis, we present a series of 28 cases of vulvar irritation associated with the use of Always sanitary napkins.

about their previous and subsequent use of products for menstrual protection, any associated symptoms, other potential causes or risk factors for vulvitis and pertinent aspects of the medical history. To assess the proportion of women in the practice population who used Always sanitary napkins we interviewed a comparison group of women from the same practice, matched for date of visit, age within 5 years, referral status and reason for using sanitary product (e.g., menses, urinary incontinence or discharge).

Thirty-four women met the symptom criteria, and all had been using Always sanitary napkins. After the interviews, five women were excluded because of coexisting chronic vulvar or vaginal conditions (recurrent herpes, known local skin allergies and chronic introital dyspareunia). Their symptoms diminished after they stopped using the Always napkins, but we excluded them because of the confounding causes of the vulvitis. An additional woman was excluded because subsequent use of Always napkins was well tolerated. The 28 remaining women ranged in age from 20 to 64 years (median 32 years). Twenty-four women used the sanitary napkins during menses only; the other four used them every day. The women were asked about menstrualprotection methods, use of sanitary napkins for other reasons and episodes of menstrual or postmenstrual vulvar itching or burning during the 6 months before the index episode. Thirteen women had symptoms with their first exposure to the product; reactions in the others developed only on repeat exposure. Symptoms were typically recurrent: 19 of the women had had four or more episodes of symptoms, and 8 of the 20 women who had used the product for at least 6 months had had symptoms every month during that time. Symptoms were first noticed 1 to 9 days (median 3 days; interquartile range [IQR] 2 to 4 days) after use of the sanitary napkins was started during each menses and lasted for a median of 4.5 days (IQR 4 to 7 days). The four women who used the napkins every day had constant irritation. Of the 28 women 13 also had erythematous papular eruption. Symptoms did not disappear immediately after the women stopped using the sanitary napkins; rather, the itching and burning lasted for a median of 3 days (IQR 2 to 5 days) afterward. In six of the women the symptoms began 1 to 2 days after napkin use was stopped. All of these women experienced only postmenstrual itching and burning of the vulva on at least three occasions. Before the index visit none of the women had identified the sanitary napkins as a possible cause of their symptoms: most reported "vaginal infection every month." We informed patients at the end of the index

We reviewed the charts of all women seen in a gyne-

cology practice in Montreal between September 1991 and September 1994 who had presented with symptoms indicative of contact vulvitis associated with the use of sanitary napkins. Suspected cases had to meet the following criteria: itching or burning of areas that would be in contact with a sanitary napkin (mons pubis, extemal surfaces of the vulva and perineum) and onset of symptoms at least 1 day after the use of sanitary napkins was started and less than 5 days after the use was stopped. Patients were interviewed by telephone by their attending physician to obtain more detailed information
CAN MED ASSOC J * 15 AVR. 1996; 154 (8)

visit of the possible cause of their symptoms and advised them to suspend use of the product. Twenty-three of the 28 women switched to another product for the next 3 months and had no further vulvar irritation. Three women continued to use Always napkins and had recurrent irritation at each menses until they discontinued its use, whereupon symptoms disappeared. One woman continued to use Always napkins for 3 months after the index visit without a problem, but when she used them again later she experienced irritation. Another woman could not recall whether she had had recurrent irritation during the 3 months after switching brands, but she did later reuse Always napkins and experienced irritation. Seven women later used Always napkins again and experienced recurrent vulvar itching and burning. C. albicans or bacterial vaginitis was present at the index visit in 5 of the 28 women. Although these women had a potential microbial cause of vulvitis, the clinical picture was that of contact or irritant dermatitis. All five had at least 3 months of exclusively menstrual or postmenstrual irritation. Cyclic symptoms continued in one of the five patients after treatment for Candida and resolved only after use of Always napkins was stopped. Only I of the 28 women reported using scented napkins; 7 were unsure whether they were scented. None used talcum powder, feminine hygiene spray or douches. None had recently changed brands of soap, laundry detergent or fabric softener. None had lichen sclerosis or vulvar epithelial hyperplasia. Three had a history of nonvulvar eczema or psoriasis but had no active disease at the time of the index visit. None of the women was using vulvar or vaginal medications when the irritation began. Six had a history of contact dermatitis not involving the vulvar area, and five had a history of skin manifestations related to drug allergy. No patient had diabetes. The vulvar symptoms were not related to obesity: the median body mass index was 22.8 (IQR 20.9 to 24.2), which was within normal limits. None of the women used spermicide; five were exposed to condoms without resulting irritation. In the comparison group of 29 patients from the same practice, 8 (28%) were using Always napkins; 1 reported that they caused vulvar irritation but that she liked the "wings" feature. Eleven (38%) were using another brand of napkin, and 10 (34%) were using tampons.

The clinical picture of recurrent menstrual or postmenstrual vulvitis, described by some of the patients as "repeated yeast infections"t or "chronic vaginitis," was always associated with the same brand of sanitary napkin. It is improbable that this was a chance occurrence: the Canadian market share of Always napkins in 1993 was

about 30% (Ontario Consumer Information Office, Procter & Gamble, Toronto: unpublished data), and the proportion of women in the comparison group who used this brand was 28%. Despite the rather striking pattern of recurrence, none of the women in the study group had made the connection between their sanitary napkins and the irritation. Few physicians are aware of this potential problem with Always napkins, although colleagues we have since alerted have confirmed our observations. We suspect that this relatively common reaction has escaped notice for several reasons. In our experience, it did not always occur with the initial use of the product or immediately upon exposure, and symptoms tended to persist and to worsen after the women stopped using the napkins. In some cases the symptoms began after the end of their menses. If the dermatitis is mistaken for Candida vulvitis, which is similar in appearance although not in distribution, its resolution coincident with antifungal therapy may mislead the patient and her physician into believing that it was a yeast infection. Indeed, we saw several patients who had been treated for "monthly recurring yeast infection" that resolved after the correct diagnosis. Clinicians are generally unaware of the possibility that unscented sanitary napkins can cause contact dermatitis. Although Pincus3 and others6 have mentioned the possibility of allergy to the rubber or perfumes used in sanitary products, contact dermatitis to sanitary nap.kins is not mentioned in major gynecology or dermatology textbooks or in texts on diseases of the vulva.2',7,9 Since almost all of the women in our study used unscented napkins, the cause of their symptoms was likely different from that in the previously reported cases irritant rather than allergic. Many of our patients like Always sanitary napkins because of their length, the "wings" that protect the underwear and the wicking of blood away from the surface through the Dry Weave plastic. This plastic, which lies directly in contact with the skin, may chafe and result in irritant dermatitis in some women. However, the timing and duration of symptoms suggest an allergic reaction to some component of the sanitary napkin. From our study we cannot determine whether the reactions were primarily an irritant or an allergic contact dermatitis. Further investigation, including patch testing to various components of the Always napkins, is under way to elucidate the mechanism responsible for the vulvitis. Certain questions about the syndrome cannot be answered within the framework of a case series. The spectrum of severity and the prevalence cannot be identified, since women making their own diagnosis would simply change products without consulting their physician, and the proportion of women using Always napkins who have experienced vulvar irritation cannot be estimated.
CAN MED ASSOC J * APR. 15, 1996; 154 (8) 1175

Hanke-Baier and associates' observed skin irritation from Always Excel Plus and another sanitary pad in 256 women and reported "up to moderate erythema" of the contact area during menstruation but did not provide data or analysis by type of pad. Because our case definition included Always use, we could not determine the proportion of cases of menstrual or postmenstrual vulvitis attributable to this brand. However, the novelty of this pattern alerted us to the diagnosis, and in our experience the vulvitis has been associated with the use of this product in almost all cases. Our findings reveal a potentially important cause of recurrent vulvitis that has hitherto escaped notice. Because of the widespread use of Always sanitary napkins in Canada, physician awareness of the association will enable effective advice and relief for a large number of women suffering from "chronic vaginitis."

3. 4.



tice of Clinical Gynecology, 2nd ed, Churchill Livingstone, New York, 1990: 583-586 Pincus SH: Vulvar dermatoses and pruritis vulvae. [review] Dermatol Clin 1992; 10: 297-308 Larsen WG: Sanitary napkin dermatitis due to the perfume. ArchbDermatol 1979; 115: 363 Sterry W, Schmoll M: Contact urticaria and dermatitis from self-adhesive pads. Contact Dermatitis 1985; 13: 284-285 Maiback HI, Dannaker CJ, Lahti A: Contact skin allergy. In Middleton E Jr, Reed CE, Ellis EF et al (eds): Allergy, Principles and Practice, 4th ed, Mosby, St Louis, 1993: 1605-1648 Wilkinson JD, Rycroft RJG: Contact dermatitis. In Champion RH, Burton JL, Ebling FJG (eds): Rook!Wilkinson/Ebling Textbook of Dermatology, 5th ed, Blackwell Scientific Publications, Oxford, England, 1992: 611-716 Ridley CM: The Vulva, Churchill Livingstone, Edinburgh,

1. Hewitt J, Pelisse M, Paniel B: Diseases of the Vulva, McCraw Hill, London, England, 1991: 29-32, 49-51 2. Kase NG, Weingold AB, Gershenson DM: Principles and Prac-

9. Jones HW, Wentz AC, Burnett LS: Novak's Textbook of Gynecology, I th ed, Williams & Wilkins, Baltimore, 1988 10. Hanke-Baier P, Johannigmann J, Levin R et al: Evaluation of vaginal and perineal area during the use of external sanitary protection throughout the menstrual cycle. Acta Obstet Gynecol Scand 1994; 73: 486-491

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THERAPEUTIC CLASSIFICATION Angiotensin Converting Enzyme Inhibitor INDICATIONS AND CLINICAL USE The treatment of mild to moderate essential hypertension. May be used with thiazide diuretics. Use when treatment with a diuretic or a beta-blocker are contraindicated, were found ineffective or have been associated with unacceptable adverse effects. Not recommended for CHF and renovascular hypertension. When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury or even death ot the developing fetus. When pregnancy is detected MONOPRIL should be discontinued as soon as possible.
Hypersensitivity and history of angioedema related to previous ACE inhibitor therapy. WARNINGS Angioedema associated with laryngeal involvement may be fatal. If laryngeal stridor or angioedema of the tongue, or glottis occurs, discontinue immediately, administer epinephrine (0.3 - 0.5 mL 1:1000) and carefully observe patient until swelling disappears. Swelling confined to the face and lips generally resolves without treatment; antihistamines may be used. Patients with a history of angloedema may be at increased risk. Hypotension: Usually occurs after first or second dose or when the dose was increased. More likely in patients who are volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Patients with severe CHF, ischemic heart or cerebrovascular disease should start therapy under close medical supervision, then followed closely for the first weeks of treatment and whenever diuretic or MONOPRIL dose is increased. Neutropenia/Agranulocytosis: Incidence is rare. Consider periodic monitoring of white blood cell counts. PRECAUTIONS Impaired Renal Function: Assess renal function before initiating therapy. Use with caution in patients with renal insufficiency, and closely monitor. Surgery/Anesthesia: Hypotensive effects of anesthetics and analgesics may be augmented. Correct by volume expansion. Hyperkalemia and Potassium-Sparing Diuretics: Use with caution. Risk factors include renal insufficiency, diabetes mellitus, and concomitant use of agents to treat hypokalemia or other drugs associated with increases in serum potassium (e.g. heparin).


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Adverse reactions occurring in 2 1% of 1048 hypertensive patients in controlled clinical trials treated with MONOPRIL monotherapy were: orthostatic hypotension (1.4%), rash (1.0%), sexual dysfunction (1.7%), nausea/vomiting (1.4%), diarrhea (1.4%), pyrosis (1.0%), dry mouth (1.0%), fatigue (2.8%), headache (4.6%), dizziness (3.8%) and cough (4.0%). DOSAGE AND ADMINISTRATION Individualize dosage. Consider recent antihypertensive drug treatment, extent of blood pressure elevation and salt restriction. The recommended initial dose of MONOPRIL is 10 mg once daily. Adjust according to blood pressure response, at intervals of at least two weeks. Usual maintenance dose is 20 mg once daily. Do not exceed a dose of 40 mg daily. If antihypertensive effect is not satisfactorily maintained for 24 hours, consider either twice daily administration with the same total daily dose, or an increase in dose. If blood pressure is not controlled with MONOPRIL alone, a diuretic may be added. Concomitant Diuretic Therapy: If possible, discontinue diuretic for two to three days before beginning therapy with MONOPRIL to reduce likelihood of hypotension. If not, use an initial dose of 10 mg MONOPRIL with careful medical supervision for several hours and until blood pressure has stabilized. Titrate dosage of MONOPRIL to obtain optimal response. Dosing Adjustment in Renal lmpairment: With normal liver y. Initial dose is 10 mg function no dosage adjustmert is once daily. Dosing Adjustmen in Hepatic ImpaItment With normal renal function no dosage adjustment is necessary. Initial dose of MONOPRIL is 10 mg one daily. No dosage adjustment is necessary in ederly hypertensives with normal renal and hepatic function. AVAILABILITY MONOPRIL 10 mg tablets are white to off-white, flat end diamond shaped, compressed tablets with a partial bisect bar engraved with BMS on one side and MONOPRIL 10 on the other. MONOPRIL 20 mg tablets are white to off-white, oval shaped, compressed tablets engraved with BMS on one side and MONOPRIL 20 on the other. Bottles of 100 tablets. Full Product Monograph available upon request.

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CAN MED ASSOC J * 15 AVR. 1996; 154 (8)