Adverse Events of SARS-CoV-2 Therapy: A Pharmacovigilance Study of the FAERS Database.

BACKGROUND: Over the past 2 years of the several strategies recommended to help fight COVID-19, nirmatrelvir/ritonavir is a novel drug shown in the EPIC-HR phase 2 to 3 clinical trial to lower COVID-19-related death or hospitalization at day 28 when compared with placebo. OBJECTIVE: Our study's aim was to explore the reported adverse events (AEs) associated with nirmatrelvir/ritonavir use for COVID-19. METHOD: We conducted a retrospective analysis using the FDA Adverse Event Reporting System (FAERS) database for AEs, listing nirmatrelvir/ritonavir as the primary drug between January and June 2022. The primary outcome was the incidence of reported AEs associated with nirmatrelvir/ritonavir. The OpenFDA database was queried using Python 3.10 to collect the AEs and Stata 17 was used to analyze the database. Adverse events were analyzed by associated medication, with "Covid-19" excluded. RESULTS: A total of 8098 reports were identified between January and June 2022. Most reported complaints in the AE system were COVID-19 and disease recurrence. The most common symptomatic AEs were dysgeusia, diarrhea, cough, fatigue, and headache. Event rates significantly rose between April and May. Disease recurrence and dysgeusia were the most commonly reported complaints for the top 8 concomitant drugs identified. Cardiac arrest, tremor, akathisia, and death were reported in 1, 3, 67, and 5 cases, respectively. CONCLUSIONS AND RELEVANCE: This is the first retrospective study done on reported AEs associated with nirmatrelvir/ritonavir use for COVID-19. COVID-19 and disease recurrence were the most reported AEs. Further monitoring of the FAERS database is warranted to periodically reassess the safety profile of this medication.

A Unique Presentation of Extrapulmonary Legionella: Rhabdomyolysis-Induced Acute Renal Failure and Cerebellar Dysfunction.

Legionella is most known for causing pneumonia. However, it is a systemic disease that can directly cause severe multi-organ injury in what is sometimes referred to as "extrapulmonary Legionella." In this case report, a reasonably healthy 80-year-old man is found to have Legionella pneumonia complicated by rhabdomyolysis with acute, severe, non-oliguric acute kidney injury, uremic encephalopathy, transaminitis, and cerebellar dysfunction. With a 14-day course of azithromycin and prompt initiation of dialysis, the patient's pneumonia and systemic sequelae improved. This case demonstrates the importance of considering Legionella in the differential diagnosis of patients who present with community-acquired pneumonia and multi-organ dysfunction. Prompt diagnosis and management may decrease mortality associated with this disease sequela.

Iodinated Contrast-Induced Thyroid Storm With Concomitant Cardiac Tamponade: A Case Report.

A thyroid storm is a rare but life-threatening condition caused by the exaggeration of the clinical manifestations of thyrotoxicosis. The symptoms of thyroid storms are non-specific in nature, making the Burch Wartofsky Point Scale (BWPS) a valuable resource in the diagnosis of thyroid storms. Though not part of the BWPS scoring criteria, literature reviews have shown an increasing number of reports of pericardial effusion secondary to thyrotoxicosis. Pericardial effusion is a well-known sequela of hypothyroidism that, in severe cases, can cause cardiac tamponade. With increasing reports, clinicians should be aware that pericardial effusions can develop secondary to both underactive and overactive thyroid states. We present a case of iodine contrast-induced Jod-Basedow in a 29-year-old with a prior history of Graves disease with concomitant pericardial effusion requiring thyroidectomy.

Repaglinide-Induced Acute Pancreatitis.

Acute pancreatitis is a common reason for hospitalization in the United States and can have a high degree of morbidity and mortality if not treated appropriately. Establishing the diagnosis and following guideline-directed medical therapy are both important. In the Western world, the most common causes include acute alcohol overuse, hypertriglyceridemia, gallstone pancreatitis, post-instrumentation including endoscopic cholangiopancreatography, and medication side effects. Our team describes the case of an 84-year-old male that was found to have acute pancreatitis secondary to repaglinide, a commonly used medication for the management of diabetes mellitus. The diagnosis was made based on the imaging findings, physical examination, and the corresponding laboratory markers. The patient was also found to have a blood-alcohol level at baseline and triglyceride levels within normal range. The patient's symptoms resolved with the cessation of repaglinide administration. Our team hopes to make the medical community more aware of the potential association between repaglinide and the potentially rapidly debilitating disease.