Thromboembolism and Oral Contraceptives During the COVID-19 Pandemic: A Disproportionality Analysis Within the Spanish Pharmacovigilance Database.

BACKGROUND: Thromboembolic events (TEs) are known to be a severe complication for COVID-19. They are associated with a systemic inflammatory response syndrome with coagulation cascade activation. OBJECTIVE: The aim of this study was to determine a potential association between the COVID-19 pandemic and the increment of the risk of suspected TEs in women on systemic hormonal contraceptives (SHCs). PATIENTS AND METHODS: This study utilised a case/non-case approach in the Spanish Pharmacovigilance Database, which includes more than 290,000 cases of suspected adverse drug reactions (ADRs). The reporting odds ratio (ROR) was calculated during an initial pandemic period in 2020 compared with a pre-pandemic period in 2019 and an additional control period in 2018. RESULTS: While there was a decreased number of ADR notifications for any medications and for any type of ADR in patients on SHCs during the pandemic period, the TE ROR for all SHCs was higher in the 2020 pandemic period [ROR = 11.8 (5.6-24.7)] relative to the pre-pandemic period in 2019 [ROR = 6.3 (3.2-12.5)] and the additional control period in 2018 [ROR = 4.6. (2.1-9.9)]. In contrast, ROR for progestogen-only contraceptives was lower during the pandemic as compared with the two control periods. CONCLUSION: The reported disproportionality of TEs in women on SHCs rose during the pandemic period. This suggests a potential interaction of the drug (SHC) with COVID-19, which led to an increased risk of TEs in women exposed to both factors. This should be taken into consideration in the context of the COVID-19 pandemic.

[Amoxicillin-induced cholestatic hepatitis]. / Hepatitis colestásica por amoxicilina.

Drug-induced hepatotoxicity is a challenge in daily clinical practice. One of the most frequent causes is antibiotics. However, amoxicillin-induced liver injury is uncommon. We report the case of an 87-year-old man who developed cholestatic hepatitis after ingesting amoxicillin 500 mg/8 hours for dental disease. A review of the literature on this topic is provided.

Prevalence of CYP2C9 polymorphisms in the south of Europe.

CYP2C9 is a major liver enzyme responsible of the metabolism of many clinically important drugs. The presence of CYP2C9 genetic polymorphisms has been associated with marked interindividual variability in its catalytic activity that could result in drug toxicity. Here we present frequencies of the most common CYP2C9 coding variants CYP2C9*2 (C430T) and CYP2C9*3 (A1075C) in representative samples of four regions from Spain (Basque Country, n=358; Catalonia, n=240; Central Spain, n=190 and Galicia, n=288) and one northern Italian region, (Verona, n=164), which range between 0.125 and 0.165 in the case of CYP2C9*2 and between 0.071 and 0.085 for CYP2C9*3. No significant differences between CYP2C9 allele frequencies were found comparing all the sampled populations. A more extensive comparative analysis using allele frequency data of populations widely spread over Europe was performed, showing significant differences in the CYP2C9*2 allele frequencies distribution between some of the regions, being quite homogeneous in the case of CYP2C9*3 variant. The results obtained show that above 40% of our samples carry a mutate allele, which can result in a poor metabolization of low therapeutic index drugs as oral anticoagulants (warfarin, acenocoumarol), oral antidiabetic drugs and some non-steroidal anti-inflammatory drugs. Our study constitutes both a large (n=1240) and robust allele frequency database on CYP2C9 polymorphisms, which represents one of the most numerous CYP2C9*2 and *3 database existing to date.

Hepatitis colestásica por amoxicilina / Amoxicillin-induced cholestatic hepatitis

La hepatotoxicidad farmacológica es un reto en la práctica clínica diaria. Los antibióticos son una de las causas más frecuentes. Sin embargo, el daño hepático por amoxicilina sola es poco frecuente. Presentamos el caso de un paciente varón de 87 años que presentó colestasis hepática con buena evolución clínica tras la ingesta de amoxicilina 500mg/8h por patología dental. Se hace una revisión de la literatura médica publicada sobre este tema (AU)

Drug-induced hepatotoxicity is a challenge in daily clinical practice. One of the most frequent causes is antibiotics. However, amoxicillin-induced liver injury is uncommon. We report the case of an 87-year-old man who developed cholestatic hepatitis after ingesting amoxicillin 500mg/8hours for dental disease. A review of the literature on this topic is provided (AU)

Metformina y deficiencia de vitamina B12 / Metformin and vitamin B12 deficiency

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Déficit de vitamina B12 secundario a la toma de metformina / Vitamin B12 deficiency secondary to metformin therapy

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