Afatinib-induced toxic epidermal necrolysis: A case report with a literature review.

We present a 70-year-old female patient diagnosed with epidermal growth factor receptor-mutated metastatic non-small cell lung cancer (T4N2M1a), who developed afatinib-induced toxic epidermal necrolysis (TEN). We have also performed a PubMed/Medline literature review to detect other possible cases of TEN/Stevens-Johnson syndrome associated with afatinib treatment and found only 5 other cases reported. To our best knowledge, this is the first case of afatinib-induced TEN successfully treated with cyclosporine.

Incidence of Suspected Serious Adverse Drug Reactions in Corona Virus Disease-19 Patients Detected by a Pharmacovigilance Program by Laboratory Signals in a Tertiary Hospital in Spain: Cautionary Data.

BACKGROUND: From March to April 2020, Spain was the center of the SARS-CoV-2 pandemic, particularly Madrid with approximately 30% of the cases in Spain. The aim of this study is to report the suspected serious adverse drug reactions (SADRs) in COVID-19 patients vs. non-COVID-19 patients detected by the prospective pharmacovigilance program based on automatic laboratory signals (ALSs) in the hospital (PPLSH) during that period. We also compared the results with the suspected SADRs detected during the same period for 2019. METHODS: All ALSs that reflected potential SADRs including neutropenia, pancytopenia, thrombocytopenia, anemia, eosinophilia, leukocytes in cerebrospinal fluid, hepatitis, pancreatitis, acute kidney injury, rhabdomyolysis, and hyponatremia were prospectively monitored in hospitalized patients during the study periods. We analyzed the incidence and the distribution of causative drugs for the COVID-19 patients. RESULTS: The incidence rate of SADRs detected in the COVID-19 patients was 760.63 (95% CI 707.89-816.01) per 10,000 patients, 4.75-fold higher than the SADR rate for non-COVID-19 patients (160.15 per 10,000 patients, 95% CI 137.09-186.80), and 5.84-fold higher than the SADR rate detected for the same period in 2019 (130.19 per 10,000 patients, 95% CI 109.53-154.36). The most frequently related drugs were tocilizumab (59.84%), dexketoprofen (13.93%), azithromycin (8.43%), lopinavir-ritonavir (7.35%), dexamethasone (7.62%), and chloroquine/hydroxychloroquine (6.91%). CONCLUSIONS: The incidence rate of SADRs detected by the PPSLH in patients with COVID-19 was 4.75-fold higher than that of the non-COVID-19 patients. Caution is recommended when using medications for COVID-19 patients, especially drugs that are hepatotoxic, myotoxic, and those that induce thromboembolic events.

Antibiotic-associated suspected adverse drug reactions among hospitalized patients in Uganda: a prospective cohort study.

We sought to determine the prevalence at admission and incidence during hospitalization of antibiotic-associated suspected adverse drug reactions (aa-ADRs) among Ugandan inpatients; and to characterize these aa-ADRs. We conducted a prospective cohort study of 762 consented adults admitted on medical and gynecological wards of the 1790-bed Mulago National Referral Hospital. Thirty percent were known HIV-seropositive (232/762). Nineteen percent (148/762; 95% CI: 17-22%) of inpatients experienced at least one aa-ADR. At hospital admission, 6% (45/762; 95% CI: 4-8%) of patients had at least one aa-ADR; and 15% (45/300; 11-20%) of those who had received antibiotics in the 4-weeks preadmission. Twenty-four (53%) of these 45 patients had serious aa-ADRs. The incidence of aa-ADRs was 19% (117/629; 95% CI: 16-22%) of patients who received antibiotics [community-acquired: 9% (27/300; 95% CI: 6-13%); hospital-acquired: 16% (94/603; 95% CI: 13-19%)]: 39 (33%) of 117 patients had serious aa-ADRs. Of 269 aa-ADRs, 115 (43%) were community-acquired, 66 (25%) probable/definite, 171 (64%) preventable, 86 (32%) serious, and 24 (9%) rare. Ceftriaxone was the most frequently implicated for serious hospital-acquired aa-ADRs. Cotrimoxazole, isoniazid, rifampicin, ethambutol, and pyrazinamide were the most frequently linked to serious community-acquired aa-ADRs. Fatal jaundice (isoniazid), life-threatening difficulty in breathing with shortness of breath (rifampicin) and disabling itchy skin rash with numbness of lower swollen legs (ethambutol, isoniazid) were observed. Pharmaceutical quality testing of implicated antibiotics could be worthwhile. Periodic on-ward collection and analysis of antibiotic-safety-data standardized by consumption is an efficient method of tracking antibiotics with 1%-risk for serious aa-ADRs.

Analysis behavior of patients with serious adverse drug reaction using statins leading to rhabdomyolysis / 中国基层医药

Objective To analyze the behavior of patients with serious adverse drug reactions and look for risk factors leading to serious adverse drug reactions .Methods Patient medication behavior evaluation method was established,which was used in cases of serious adverse reaction caused by stains in recent three years in Beijing Chuiyangliu Hospital .Clinical pharmacists participated in field survey .Medication behavior of patients was analyzed from three aspects of knowledge ,attitude and ability .Results Three patients had serious adverse reactions occurred in recent 3 years,drugs were suspected of simvastatin and atorvastatin .The score of medication knowledge was lower than 20%.The score of health attitude was lower than 20%.The score of taking ability was lower than 20%. Conclusion In the investigation of serious adverse reaction ,pharmacists found the risk behavior of patients with daily medication is an important cause of patients with serious adverse reaction .Pharmacists should strengthen the drug education and publicity ,especially in patients with risk factors of medication behavior such as knowledge ,attitude and ability in their daily work .

Analysis of serious adverse drug reactions of anti-infective drugs / 中国药学杂志

OBJECTIVE: To analyze the serious adverse drug reaction reports in Beijing during 2012 and provide reference to clinic about the reasonable use of anti-infective drugs.

Preventive Measures against Adverse Drug Reactions on the Basis of Case Analyses of Monitored Serious Adverse Events / 薬剤疫学

Objective : To analyze serious adverse drug reactions (ADRs) in terms of their occurrence, the related factors and the necessary means to avoid such ADRs, and proposal of possible preventive measures against ADRs.<BR>Design : Case series.<BR>Methods : Out of 598 cases collected through an in-patient drug monitoring conducted from April 1990 to March 1996 in Hospital T, 59 cases which were of Grade 3 of the Ministry of Health and Welfare Standards for Severity Classification of ADRs were selected for this study. By classifying the causes of and the possibilities to avoid reactions in 59 cases, we discussed measures to prevent serious reactions to drugs.<BR>Results : Symptoms involved were, in descending order, hypersensitivity, hepatic disorder, blood disorder, renal failure, cadiovascular system disorder, and other symptoms. Causal drugs were, in descending order, antibiotics, central nervous system drugs, circulatory drugs, gastrointestinal drugs, and other drugs.<BR>Regarding the causes for the ADRs, factors involved in “usage”, such as indication and dosage, represented the highest rate, 40.7%. In a detailed survey of the possible avoidance of such reactions, 49.2% of serious ADRs were judged preventable by careful administration of the drugs. Further, 15.3% of the cases were thought to have resulted from a lack of or an inadequate description in the package insert.<BR>Conclusions : The study indicates that the following steps are necessary to prevent ADRs. : (1) To be appropriately cautious to indications and dosages of the drug (including, in particular, indications and dosages for the aged, and renal failure or allergic patients, and the adjustment of dosage on the basis of drug-drug interaction); (2) To adhere strictly to contraindication ; (3) To offer suitable information on the ADRs to the patient who has experienced such a reaction ; and, (4) To be aware of unusual conditions by careful follow-up at an early stage after the administration.<BR>The following action plans were considered important for carrying out the steps mentioned above : 1) to deepen medical workers awareness to prevent ADRs ; 2) to establish a system that can correctly offer fundamental and essential information to physicians ; 3) to standardize drug treatment according to patient condition (age, renal-failure, etc.) and to establish a safety assurance system.