Stimulated Reporting of Adverse Events Following Immunization with COVID-19 Vaccines.

In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were still underway. Even for vaccines that have completed phase 3 trials, safety data may not be comprehensive. This retrospective observational study was conducted at a designated Regional Training Centre for Pharmacovigilance cum Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India. The data sources were stimulated spontaneous reports of Adverse Events Following Immunization (AEFI) due to the COVID-19 vaccines from 10 January to 31 December 2021. A total of 51,010 COVID vaccine doses were administered during the study period. There were 330 AEFI reported (AEFI rate: 0.65%). Six AEFI were serious events among which three were Adverse Events of Special Interest. The majority of the AEFI were systemic, reported after the first dose, and with an onset between 1 and 24 h after vaccination. On comparing Covishield and Covaxin, there were no statistically significant differences in the AEFI reported with either vaccine in terms of gender, seriousness, lag period, duration, recovery, causality, treatment received for AEFI, presence of co-morbidity, or history of COVID-19 infection. Overall, the rates of AEFI was uncommon, and serious AEFI were rare with both Covishield and Covaxin, with a higher rate after the first dose. Whether immunological tolerance or allayed anxiety was responsible for the lower AEFI risk with the second dose remains to be investigated.

Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough.

OBJECTIVES AND METHODS: In September 2018, the government of India banned 328 fixed dose combinations (FDCs), 24 of which are combinations containing topical steroids. To assess what impact can be expected from this regulatory action, we analyzed reports of adverse drug events due to topical corticosteroids at a hospital-based pharmacovigilance center between January 2017 and August 2018. RESULTS: Among 34 different steroid-containing FDCs responsible for 485 reports of ADEs with topical steroids, only three preparations, accounting for 50.10% of ADEs, come under the umbrella of the recent ban. Clobetasone propionate (68.87%) and betamethasone (28.45%) were the corticosteroids most frequently associated with adverse events. Most of the steroid preparations (87.84%) had been bought without a prescription for the treatment of dermatophytoses (76.70%). Males (77.73%) were predominantly affected, and nearly half (47.43%) of the patients were between 21 and 30 years of age. Skin atrophy (50.10%), striae (25.54%), and hypopigmentation (19.79%) were the major ADEs. CONCLUSION: Nearly half of the cutaneous adverse effects were due to topical steroid combinations which are still widely available over the counter.

Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions.

BACKGROUND: The Pharmacovigilance Program of India recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while many clinicians prefer the Naranjo algorithm for its simplicity. In the present study, we assessed agreement between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. MATERIALS AND METHODS: In this study, 842 individual case safety reports were randomly selected from 1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary healthcare Institute in Central India between 2016 and 2018. Two well-trained independent groups performed the causality assessment. One group performed a causality assessment of the 842 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. RESULTS: Cohen's kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. "No" agreement was found between the two scales {Kappa statistic with 95% confidence interval = 0.048 (P < 0.001)}. CONCLUSION: There was no agreement found between the WHO-UMC criteria and the Naranjo algorithm in our study.

A case report on azathioprine-induced euprolactinemic galactorrhea.

Galactorrhea is characterized as an inappropriate discharge of milk-containing fluid from the breast. It has various causes including physiological and pathological. It may also be caused by many drugs. Although galactorrhea is usually associated with increased serum prolactin levels, it has been reported to occur in the absence of hyperprolactinemia. Cases of azathioprine-induced galactorrhea with normal prolactin level in a 22-year-old female patient with prurigo have been reported. It was noticed that the patient had no history of galactorrhea in the past.

Erythema multiforme induced by tetanus toxoid vaccine.

Erythema multiforme (EM) is an immunomediated mucocutaneous disorder of usually unknown etiology which has been known to occur following an infection like herpes virus or exposure to drugs. It primarily affects adolescents, young adults, but can occur at any age. Vaccines are also documented as precipitating factors for EM. In the year 2017, the case of a 25-year-old male patient with lesions of EM which appeared after 30 min of administration of tetanus toxoid vaccine is reported here.

Fixed-drug Eruptions: What can we Learn from a Case Series?

BACKGROUND: A fixed-drug eruption (FDE) is a unique cutaneous adverse drug effect in the form of recurrent lesions at the same site after re-exposure to the offending agent. AIM: The aim of the study was to identify changes in trends in fixed drug eruptions with regard to causative drug or patient risk factors. METHODS: Cases of FDEs encountered between March 2014 to May 2017 during routine pharmacovigilance activities were analyzed. RESULTS: FDEs made up 8.4% of total adverse drug reactions and 11.1% of cutaneous reactions. Majority of the patients were adults between 18 and 45 years old. The average lag period between drug intake and appearance of FDE was 2.04 days. Commonly affected sites were extremities, lips, head and neck, and genitalia. Number of FDE lesions varied from 1 to > 6, with nearly half the patients (46%) presenting with a single lesion. Antimicrobials (80.6%) and nonsteroidal anti-inflammatory drugs (20.8%) were most frequent drugs implicated. Route of administration was oral for all causative drugs. History of an FDE was positive in 26 (50.2%) of the cases. Majority of the patients (21 out of 25 or 84%) whose lesions appeared within minutes to hours of suspected drug intake had a history of FDE. Furthermore, 66.7% of patients with multiple lesions had a history of FDE while only 34.8% of patients with a single lesion had such a history. CONCLUSION: FDEs are common cutaneous reactions with antimicrobials and anti-inflammatory agents, with increased likelihood of extensive and multiple lesions in patients with a history of FDE.

Fixed drug eruption due to levocetirizine.

A fixed drug eruption (FDE) is a cutaneous adverse drug reaction due to Type IV or delayed cell-mediated hypersensitivity. Antihistamines, which antagonize the action of histamine during an allergic reaction by blocking the H1 histamine receptors, are used routinely for the treatment of various allergic disorders such as urticaria, eczemas, and also in itchy lesions of skin like scabies. Levocetirizine, an active (R)-enantiomer of cetirizine, is a newer or second generation antihistamine, with more specific actions and fewer side effects, including cutaneous reactions. FDE due to levocetirizine as well as with cetirizine are rare. We report a case of levocetirizine induced FDE in a 49-year-old male patient with scabies. The patient had a history of cetirizine induced FDE in the past.

Study of cenesthesias and body image aberration in schizophrenia.

BACKGROUND: Abnormal body sensations are reported frequently by schizophrenic patients. Cenesthesias are infrequently recognized and diagnosis of cenesthopathic schizophrenia is rarely made. There are very few studies regarding the same. AIMS AND OBJECTIVES: To assess cenesthesias and different aspects of body image aberration and their relationship with psychopathology in patients with paranoid schizophrenia. MATERIALS AND METHODS: Seventy patients of paranoid schizophrenia meeting the inclusion and exclusion criteria were assessed with Positive and Negative Symptom Scale(PANSS) for psychopathology, Bonn Scale for Assessment of Basic Symptoms/Category D 'Cenesthesias' (BSABS), Image-Marking Procedure(IMP), alteration of body size and body cathexis. Assessments were made at baseline and after two weeks and assessed with SPSS 12.0. RESULTS: The most commonly endorsed items on BSABS were depersonalization, motor weakness, abnormal pain, numbness and stiffness. Patients underestimated lower extremities and feelings of body size change which was positively correlated with PANSS-scores and improved on reassessment. Cenesthesias were positively correlated with disturbances of body concept and were present at onset in 40% and change form in 75.7%. CONCLUSIONS: Cenesthesias and body image aberrations are common in paranoid schizophrenia. They are present from onset in few, change form and improve on treatment. Cenesthesias and disturbances of body concept are correlated and body size is associated with other psychopathology.