A rare case of misoprostol hypersensitivity.

Medical abortion using mifepristone-misoprostol regimen has been considered to be a safe and effective method for pregnancy termination. Misoprostol is a frequently used well tolerated drug with mild and transient side effects. Considering the safety profile mifepristone-misoprostol regimen has also been advocated by many for home-based medical abortion. However, we report herein a rare case of hypersensitivity reaction to sublingual misoprostol administered for first trimester medical abortion, where timely diagnosis and prompt intervention prevented life-threatening airway obstruction. The possibility of such rare event should be kept in mind and included in patient counselling and information especially for those who opt for outpatient abortion care so that they can seek medical help at the earliest. Copyright:

Introduction

Misoprostol is a prostaglandin E1 analogue with widespread application in obstetrics and gynaecology. Although originally approved for treating NSAID-induced peptic ulcer, it has broader application in reproductive health for various indications including medical abortion, medical management of missed and incomplete abortion, induction of labour, for prevention and treatment of postpartum haemorrhage and also pre-instrumentation dilatation of the cervix prior to dilatation and curettage, hysteroscopy etc.[1] It can be administered orally, buccally, sublingually, perrectally and pervaginally. The dosage and route of administration varies according to the indication of use. Misoprostol though considered a very well tolerated commonly used drug with minimal and transient side effects, we encountered a rare case of life-threatening hypersensitivity reaction to sublingual misoprostol administered for first trimester medical abortion.

Case Report

A 34-year-old, G2P2L1, presented at 6 weeks of gestational age for medical termination of pregnancy for social reasons. Proper evaluation and ultrasound confirmation of intrauterine location of pregnancy was done. She was not having hypertension, diabetes or any other comorbidity. She gave no history of allergy to any food or drug.

After proper counselling, she opted for medical abortion. Tablet Misoprostol 800 microgram was administered sublingually 48 h after an oral dose of 200 mg of tablet mifepristone. Within 20 min of sublingual misoprostol, patient started having itching inside the oral cavity, in the buccal mucosa, tongue, palate and lips and also in both the palms with mild shivering. The itching sensation progressed rapidly and she started feeling heaviness in the tongue with difficulty in deglutition. On general examination, she was found to be conscious and oriented, afebrile with a temp of 98°F, pulse rate of 116/min, blood pressure of 130/70 mmHg, respiratory rate of 18/min and SpO2 of 97% in room air. There was no stridor and chest was bilaterally clear on auscultation. She had facial flushing, both the upper and lower lips were oedematous with gross swelling of the tongue. Immediately, injection hydrocortisone 200 mg and injection pheniramine 22.75 mg were administered slowly intravenously on suspicion of hypersensitivity to misoprostol. Gradually, the itching sensation, swelling of the lips and tongue and difficulty in deglutition started decreasing with complete resolution of the symptoms in the next 3 h. Within an hour of the sublingual misoprostol, she also started having pain in the abdomen and bleeding per vaginum with passage of fleshy mass. Expulsion of abortus was completed in the next 5 h when her pain subsided and bleeding decreased. She continued to have bleeding per vaginum for the next 6 days. On follow-up, 2 weeks later, she was absolutely fine and confirmation of complete abortion was done by clinical examination and ultrasonography.

Discussion

Medical abortion using mifepristone and misoprostol regimen has been considered a safe and effective method of pregnancy termination.[2] The U.S. Food and Drug Administration approves use of both the drugs for medical abortion up to 70 days of gestation.[3] WHO recommends the use of 200 mg mifepristone orally followed by 24 to 48 h later by 800 micrograms of misoprostol administered vaginally, sublingually or buccally for first trimester medical abortion.[4]

Misoprostol is generally well tolerated with occasional mild side effects like nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, fever and chills.[12] The overall occurrence of adverse events reported with medical abortion is rare (0.3%).[2] Considering the safety profile, mifepristone-misoprostol regimen has also been advocated even for home-based and outpatient medical abortion services.[5]

However, in our case, sublingual misoprostol led to life-threatening hypersensitivity reaction. On literature, search reports of such hypersensitivity reaction is sparse and only three such cases could be found. Madan et al. reported a case of hypersensitivity to vaginal misoprostol administered for medical management of missed abortion.[6] Another case of severe hypersensitivity reaction occurred to sublingual misoprostol used for prevention of postpartum haemorrhage.[7] This rare adverse effect is not limited to pregnant women and a case of anaphylactic shock has also been reported following vaginal misoprostol administered for cervical ripening to a non-pregnant women posted for hysteroscopic myomectomy.[8]

In our patient, misoprostol has been found to successfully induce abortion; however, the patient developed serious hypersensitivity reaction which with timely diagnosis and prompt management prevented life-threatening airway obstruction.

Misoprostol being a frequently used drug at all levels of health care services including its use for home-based abortion awareness of primary care providers and family physicians about this rare hypersensitivity reaction is vital as early diagnosis and timely intervention can prevent grave consequences.

Thus, misoprostol though considered a very safe drug, possibility of rare and life-threatening hypersensitivity reaction should be kept in mind. Appropriate counselling about such rare events should be done to all women especially to those who opt for home-based medical abortion so that they can seek medical help at the earliest.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient (s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.