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.

Black hairy tongue (BHT) is a benign disease characterized by elongated filiform lingual papillae, with a carpet-like appearance of the dorsum of the tongue. It is has been reported to occur with a prevalence ranging from 0.6% to 11.3%. Although its etiology is not fully understood, BHT may be triggered by smoking, excessive coffee or black tea drinking, poor oral hygiene, trigeminal neuralgia, general debilitation, dry mouth as well as certain drugs. We present here a case of a patient with psychosis, depression, and benign prostatic hyperplasia, who developed BHT following treatment with a fixed dose combination (FDC) of olanzapine and fluoxetine and recovered within 3 months after withdrawal of treatment with FDC.

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 H ₁ 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.

Orticosteroids 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....

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.

BACKGROUND: The concept of listing essential medicines can lead to improved supply and access, more rational prescribing, and lower costs of drugs. However, these benefits hinge on the prescription of drugs from an Essential Medicines List (EML). Several studies have highlighted the problem of underutilization of EMLs by prescribers. Therefore, as part of prescription research by the Indian Council of Medical Research-Rational Use of Medicines Centres Network, we evaluated the extent of prescription of drugs not listed in the National List of Essential Medicines (NLEM). MATERIALS AND METHODS: Prescriptions of outpatients from participating centers were included after obtaining verbal/written informed consent as approved by the Ethics Committee, and evaluated for prescription of drugs from the NLEM 2015. RESULTS: Analysis of 4838 prescriptions from 13 tertiary health-care institutes revealed that 2677 (55.33%) prescriptions had at least one non-NLEM drug prescribed. In all, 5215 (31.12%) of the total 16,758 drugs prescribed were not in NLEM. Of these, 2722 (16.24%) were single drugs and 2493 (14.88%) were fixed-dose combinations (FDCs). These comprised 700 different drug products – 346 single drugs and 354 FDCs. The average number of non-NLEM drugs prescribed per prescription was 1.08, while the average number of all drugs prescribed was 3.35 per prescription. It was also found that some of the non-NLEM drugs prescribed had the potential to result in increased cost (for example, levocetirizine), increased adverse effects (dextromethorphan), and less effectiveness (losartan) when compared to their NLEM counterparts. Nonavailability of an essential drug (oral hydroxocobalamin) was another important finding of our study. CONCLUSION: This study highlights the extent and pattern of drugs prescribed from outside the NLEM at the tertiary health-care level and the need for training and enhanced awareness among prescribers for greater utilization of the NLEM.