Guillain-Barré syndrome after COVID-19 vaccines: A Tunisian case series.

As the COVID-19 vaccination campaign progresses worldwide, Guillain-Barré syndrome (GBS) vaccine-related cases have been reported. We carried out a retrospective, descriptive study of GBS patients following COVID-19 vaccine, submitted to the National Pharmacovigilance Center of Tunis during the period between March 2021 and May 2022. Our study aimed to identify epidemiological and clinical features of COVID-19 vaccine-associated GBS. We found 9 cases of GBS post COVID-19 vaccination; 5 of them were excluded due to the lack of information, whereas 4 cases were included in this study. Men represented 75% (3/4) of the cases. The most frequently reported vaccine type was ChAdOx1 nCoV-19 vaccine (n = 2 reports [50%]), Ad26.COV2.S vaccine and BNT162b2 vaccine in 1. The mean time interval from vaccination to symptom onset was 15.3 days. Clinical manifestations were different: classical GBS in two cases and GBS with unilateral facial palsy in the other 2 cases. All patients were treated with a course of intravenous immunoglobulin for 5 days. Three patients reported clinical improvement while one case (25%) showed treatment-related fluctuations. Our observations suggest that COVID-19 vaccines may be associated with GBS. Continuous surveillance and further studies are warranted to assess the significance of the association.

Toxicological evaluation of oral exposure to isoniazid: behavioral, biochemical, and histopathological assessments in rats.

Isoniazid (INH), being the first-line drug used as an anti-tuberculosis drug, is known to be associated with physiological deteriorations including hepatic and neurologic disturbances. This study was aimed at biochemical and behavioral characterization of toxic manifestations of isoniazid treatment in Wistar rats. Experimental animals were divided into four groups. Each group consists of six animals including the control group (saline solution), I25 group (25 mg/kg of INH), I50 group (50 mg/kg of INH), and I100 group (100 mg/kg of INH). Animals received daily INH for 30 days. Isoniazid is known to be associated with hepatotoxicity; it's among the most common causes of drug-induced toxicities. For this reason assays for aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and lactate dehydrogenase (LDH) were performed to assess liver toxicity. Moreover, behavioral study, renal, and lipid parameters were also assessed in addition to histological features of the liver and brain. Significant differences in all studied parameters were seen especially in the I100 group and a marked increase in liver enzymes activities, such as AST and ALT was observed. In another hand, there were no major clinical signs in treated animals, except fatigue and anxiety in the I100 group. On the other hand, the histological findings showed potential liver and brain injury which was evidenced by degenerative changes, infiltration, and hepatocyte necrosis, in addition to the appearance of many pyramidales cells in the gyrus. The current study findings suggest that INH interacts with multiple biochemical pathways in the body what comes up by behavioral changes and liver disturbances in animals caused by INH toxicity.

Fatal Kounis syndrome with stent thrombosis secondary to amoxicillin/clavulanic acid use: A case report and literature review.

Anaphylactic reactions are often induced by drugs, and the most frequent ones are penicillin derivates. The concurrence of acute coronary syndrome with hypersensitivity and anaphylactic or anaphylactoid reactions constitutes the Kounis syndrome. We report a case of a coronary stent thrombosis with a fatal outcome complicating an anaphylactic shock induced by amoxicillin-clavulanic acid association. A 58-year-old woman with a history of triple coronary stenting was treated by amoxicillin/clavulanic acid association for pharyngitis. One hour after the first drug intake, she developed an anaphylactic shock with acute constricting chest pain. She received intravenous hydrocortisone and was transferred to emergency department. The patient received epinephrine intravenously with fluid perfusion and oxygen. Electrocardiogram showed Pardee waves in the anterior precordial leads. Cardiac enzyme levels (troponin I) were disturbed. The patient was transferred to the coronary care unit with a diagnosis of acute myocardial infarction. The coronary angiography revealed anterior interventricular stent thrombosis. The patient experienced a cardiogenic shock with an important hemodynamic repercussion, and she died few hours later despite emergency care. The responsibility of amoxicillin-clavulanic acid association was retained in the genesis of this anaphylactic shock in front of a suggestive delay, a compatible evolution and a high semiotic score. Amoxicillin/clavulanic acid use may cause Kounis syndrome. The use of epinephrine is a challenging decision. We suggest that Kounis syndrome should be considered in the differential diagnosis of acute coronary syndrome.

Bullous Eruption Associated With Dihydropyridines With Cross Reactivity.

The spectrum of cutaneous eruptions associated with dihydropyridines is extensive, varying from exanthemas to severe adverse events. We report a case of bullous eruption, one month after starting nicardipine and lercanidipine. The same symptoms recurred few days after taking nitrendipine.

DRESS Syndrome Following Levofloxacin Exposure With Positive Patch-test.

Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) in a severe cutaneous drug reaction, which can be life threatening. Levofloxacin has not been reported in literature as a causative drug. We are presenting an exceptional case of levofloxacin-induced DRESS without eosinophilia and with positive patch-tests to levofloxacin.

Facial hyperpigmentation during imatinib therapy for gastrointestinal stromal tumor.

We report a rare case of facial hyperpigmentation during imatinib therapy for a gastrointestinal stromal tumor.

[Fixed pigmented erythema antihistamine H1: about 2 cases and review of the literature]. / Érythème pigmenté fixe aux antihistaminiques H1 : à propos de 2 cas et revue de la littérature.

We describe two cases of fixed drug eruptions induced by pheniramine (1(st) case) and loratadine (2(nd) case).

[Not Available]. / Érythème pigmenté fixe aux antihistaminiques H1 : à propos de 2 cas et revue de la littérature.

We describe two cases of fixed drug eruptions induced by pheniramine (1(st) case) and loratadine (2(nd) case).

Lichen associated with metformin.

We report an exceptional case of bullous lichen induced by metformin in a patient with diabetes mellitus.

Development of Dermatomyositis after Pfizer BioNTeh COVID-19 Vaccine: A Case Report.

INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) pandemic led to the fast development of vaccines, which is considered a medical advance in healthcare. With the extensive vaccination campaign performed worldwide, many adverse events following immunization (AEFI) were reported. Most of them were flu-like symptoms, mild and self-limiting. However, serious adverse events, such as dermatomyositis (DM), an idiopathic autoimmune connective tissue disease, have also been reported. CASE PRESENTATION: In this report, we describe a case of skin erythema, edema, and diffuse myalgia attributed at first to Pfizer BioNTeh, COVID-19 vaccination, given the temporal relationship and the absence of significant medical history. The causality assessment score was I1B2. However, after completing the etiological assessment, an invasive breast carcinoma was identified, and we retained the diagnosis of paraneoplastic DM. CONCLUSION: This study underlines the importance of completing the etiological assessment before attributing any adverse reaction to vaccination to maintain optimal patient care.

Azathioprine and Acenocoumarol Drug Interaction in Patients with Crohn's Disease: A Case Report.

BACKGROUND: Acenocoumarol is an anticoagulant with numerous drug reactions. We report here, an unusual interaction between acenocoumarol and azathioprine. CASE PRESENTATION: A 35-year-old woman, treated with acenocoumarol for thrombosis of the superior mesenteric vein, was prescribed azathioprine for Crohn's disease. Three days later, INR values decreased from 2.36 to 1.48. The dose of acenocoumarol had to almost be doubled to reach an INR value of 2.56. The interaction between azathioprine and acenocoumarol was then suspected. Few similar cases of interactions between azathioprine and another coumarin derivative, warfarin, have been reported. To our knowledge, this is the second case of such interaction reported with acenocoumarol in literature. CONCLUSION: Thus, despite the rarity of this interaction reporting, we draw attention to the importance of close monitoring of INR values in patients treated with acenocoumarol associated with azathioprine.

Erythema multiforme reactions following Pfizer/BioNTech (tozinameran) vaccination: two case-reports with positive rechallenge and review of the literature.

AIM: Pfizer/BioNTech (BNT162b2) is a COVID-19 vaccine with a reassuring safety profile. The main adverse reactions are mild local reactions. Cutaneous reactions are generally minor. The most common cutaneous reaction reported was a local injection-site reaction. CASE STUDY: Here we present 2 cases of erythema multiform (EM) following BNT162b2 vaccination with positive rechallenge. The 1st case was about a 51-year-old woman who developed 5 days after the 1st dose of the mRNA Pfizer/BioNTech (BNT162b2) a macular, erythematous, round-shaped lesions on the hands, knees and soles. She experienced a positive rechallenge one month later. In the 2nd case, a 55-year-old man presented 6 days following the 2nd shot of the mRNA Pfizer/BioNTech (BNT162b2), targetoid eruption on the upper and lower members. The patient reported that he had the same skin lesions in ankles and soles few days following the 1st shot of the same vaccine. CONCLUSION: Few cases of EM following COVID-19 vaccination were reported in the literature and positive rechallenge in only one case. Rechallenge was not performed in most cases. Our two cases are particular because of the positive rechallenge in both patients. This is the gold standard to confirm that the vaccine was the culprit agent in inducing EM.

DRESS Syndrome Associated with Liposomal Amphotericin-B in a Kidney Transplant Patient: A Case Report.

INTRODUCTION: Liposomal amphotericin B is a widely used broad-spectrum antifungal drug. It was developed to reduce nephrotoxicity and maximize the therapeutic utility of amphotericin B in the treatment of invasive fungal infections. Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome is a severe drug-induced hypersensitivity syndrome commonly associated with aromatic antiepileptic drugs. Liposomal amphotericin-B was associated with DRESS syndrome in only one case. CASE REPORT: We report an exceptional case of possible DRESS syndrome associated with liposomal amphotericin B in a 31-year-old male renal transplant recipient. Seventeen days after starting liposomal amphotericin B for visceral leishmaniosis, he developed a skin rash with elevated liver tests. Liposomal amphotericin B was then discontinued. A favourable outcome was slowly observed in one month. RESULTS AND CONCLUSION: This case scored two (possible case) based on the criteria adopted by the European group RegiSCAR. The Naranjo score for liposomal amphotericin B was four (possible).

Serious adverse drug reactions in older adults notified to pharmacovigilance.

PURPOSE: To report the serious adverse drug reactions (ADRs) in older adults notified to pharmacovigilance, to identify the incriminated drugs and to search for risk factors of occurrence. METHODS: A retrospective study including 106 serious adverse drug reactions notified to pharmacovigilance in patients aged of 65 years and more, over a period of 16 years. Imputation was established according to the French method and seriousness according to the World Health Organisation (WHO) criteria. RESULTS: Adverse drug reactions were essentially systemic. Incriminated drugs were mainly antibiotics, allopurinol and cardio-vascular drugs. Gender, age and number of administered drugs did not seem to be risk factors of serious ADRs occurrence. Among older adults, 4% died further to a serious ADRs. CONCLUSION: Systemic notification to pharmacovigilance will allow a better analysis of risk factors of serious ADRs occurrence and to insure safety and health to the older adults.

Adverse drug reactions in older adults: a retrospective study from pharmacovigilance.

PURPOSE: To assess the adverse drug reactions notified in older adults to pharmacovigilance and to identify the incriminated drugs in their genesis. METHODS: A retrospective study including 688 notifications of adverse drug reactions to pharmacovigilance in patients aged of 65 years and more, over a period of 16 years and where the responsibility of one drug or more was incriminated in the genesis of the adverse reaction. Imputation was established according to the French method and seriousness according to the World Health Organization (WHO) criteria. RESULTS: Sex-ratio W/M was 1.2. Average age was 71.3 years. The average number of administered drugs was 3.64 and polymedication was noted in 30% of cases. Adverse drug reactions were essentially cutaneous and systemic. Incriminated drugs were mainly antibiotics and cardio-vascular drugs. Serious adverse drug reactions were noted in 26%. CONCLUSION: In older adults, adverse drug reactions' notification to pharmacovigilance is necessary and allows assessing large scale epidemiologic studies to identify iatrogenic risk factors.

Cutaneous adverse drug reactions in children. A series of 90 cases.

BACKGROUND: Cutaneous adverse drug reactions (CADR) are frequent in children. They have different clinical presentations and may be caused by several drugs. AIM: To evaluate the epidemioclinical features of cutaneous adverse drug reactions (CADR) and the different causative drugs in a Tunisian paediatric series. METHODS: We have retrospectively included 90 children (under 16 years old) with a well documented cutaneous drug reaction, seen in the Department of Dermatology of Charles Nicolle hospital of Tunis over 18 years (1991-2008). Age, gender, duration of skin disorders, type of cutaneous lesions, incriminated drugs, delay between drug consumption and eruption, validation by the national pharmacovigilance centre, treatment and outcome were recorded. RESULTS: Our patients were 6.9 year-aged (sex-ratio M/F 1.19). They had maculopapular eruption (MPE) (57.7%), acute urticaria (16.6%), fixed drug eruption (14.4%), erythema multiform (2.2%), photosensitization (1.1%) or severe cutaneous drug reactions (10%).Incriminated drugs were: Antibiotics (55.5%), non-steroidal antiinflammatory drugs (18.8%), antiepileptics (11.1%), and analgesics (5.5%). Betalactamins were the most commonly incriminated antibiotics (32 out of 50 patients; 64%). Barbiturates were the most commonly incriminated anti-epileptics (7/90 cases, 7.7%). Favourable outcome was noted in all patients, even those with severe drug reactions. CONCLUSION: MPE to antibiotics were the most common kinds of CADR in children. Drug responsibility should be based on solid criteria given the frequency of MPE of infectious origin and the frequent prescription of antibiotics in paediatric population.

Seizures after vaccines.

Immunization plays an important role in achieving global health goals. Thus, vaccination is one of the essential means of preventing infectious and viral diseases. The onset of adverse events following immunization (AEFI) is common and most of the time it is a mild effect. However, stimulating the immune system during critical periods of brain development can lead to neurological effects. Among the neurological effects, we were interested in this work by seizures appearing following vaccination.