Current Drug Safety - Volume 12, Issue 2, 2017

Introduction: The recent significant breakthroughs in the understanding of the pathogenetic mechanisms of psoriasis and other immune-mediated inflammatory disorders, have led to the emergence of a wide array of biologic agents or biologics, which are especially designed to target selective intracellular or extracellular components and pathways of the dysregulated immune response. Method: These targeted biologic agents have altered the landscape in dermatotherapy aiming to offer higher therapeutic efficacy and an alternative in patients who either failed on conventional systemic regimens or have no other therapeutic options. In the last two decades, the number of the commercially available biologic agents and the extent of their use have dramatically increased; today, these compounds represent a substantial part of modern dermatologic armamentarium. Results: Due to the immunosuppressive potential of biologics, serious concerns were raised about their safety profile, already during the pre-approval period. These concerns did not subside after the incorporation of the postmarketing experience, particularly after the withdrawal of a biologic agent (efalizumab) due to its serious and even fatal side effects. Conclusion: The purpose of the present article is to review the cutaneous and systemic side effects of all systemic biologic agents used so far in modern treatment of non-malignant skin disorders and to contribute to a better and updated awareness of their safety risks among clinicians, which will enable the latter to make the best informed and personalized drug selection and therapeutic decisions. This review was mainly based on data derived from Medline and Scopus databases and from manufacturing companies, as well.

Background: Neuropsychiatric symptoms of dementia are often treated through the prescription of one or more psychotropic medications. However, limited efficacy and potential harmful side-effects has resulted in efforts to reduce the use of psychotropic medication in this population, particularly for those living in long-term care. Objectives: This study sought to describe the pattern of central nervous system medication usage in older adults with dementia living in long-term care; assess the appropriateness of prescribing against Beers criteria; and detect potential drug interactions from co-administered medications. Methods: A retrospective descriptive audit of the medical records of n=415 residents, aged >60 years with a diagnosis of dementia, from 28 long-term care facilities in Queensland, Australia. Information extracted included the types and usage of regular and Pro Re Nata central nervous system medications. Results: Of those taking medication (n=317), 68% were prescribed at least one potentially inappropriate medication, and there was a significant positive correlation between the number of medications prescribed and the number of potentially inappropriate medications. Two-hundred potential interactions with variable severity were identified from 130 residents on ≥1 medication – 38% were potentially severe interactions, 46% were moderate. Conclusion: This medication audit raises concerns that prescription of medications may still be the first resort to treat behavioural and psychological symptoms of dementia. There is a need for effective and sustainable person-centred interventions that address barriers for appropriate prescribing practice, and involve the collaboration of all healthcare professionals to optimise prescribing and improve the quality of medicines in older people with dementia.

Background: Standard triple therapy with the proton pump inhibitors, clarithromycin and amoxicillin for Helicobacter pylori infection is considered to be safe; however, the development of significant adverse events (AEs), such as skin rashes, has been reported. Objective: To reconfirm the safety of this treatment. Methods: This was a retrospective cohort study. After the exclusion of patients allergic to penicillin, 322 consecutive patients, consisting of 305 outpatients and 17 inpatients, had received the first-line eradication treatment with lansoprazole (30 mg), clarithromycin (200 mg), and amoxicillin (750 mg) twice daily for 7 days. Their medical charts were reviewed, and data were collected. Results: Three patients discontinued the treatment because of the development of a skin rash, mild diarrhea, and heat sensation, respectively. The main AE observed was mild diarrhea in 50 patients. One patient had frequent diarrhea, but it was readily resolved by a probiotic treatment. On the second or third day after the conclusion of the treatment, a skin rash also occurred in six patients (2%). Two of these patients and one patient who discontinued the treatment were administered steroids as outpatients. They recovered within 1 month. Conclusion: Most AEs that developed were mild, except for some cases of a rash. Rashes developed in spite of the exclusion of penicillin-allergic patients and mainly after the completion of the one-week treatment. As a consequence of little previous exposure to penicillin in the Japanese population, the development of delayed rashes after this exclusion may represent first sensitization to penicillin.

Objective: The objective of the study was to describe the process of implementing a technology system to improve safety and quality in all the processes involved in the treatment with parenteral antineoplastic agents within an interdisciplinary team and to analyze the errors detected and avoided by this system. Materials and Methods: This is an observational and retrospective study, where the implementation of an expert technology system in all phases of the therapeutic process is described, including: prescription, validation, preparation and administration of drugs. This system integrates a qualitative and quantitative control (with an optical codes reader and a gravimetric method). All the administration process was also observed and controlled. A descriptive analysis of the errors recorded in the various stages of the process was carried out during 3 months. Results: There were a total of 2185 drugs prescribed and prepared, belonging to 382 patients. 14 prescription errors were recorded, representing 0.6% of admixtures. All were potential errors that the system helped to avoid and did not reach the patient. Qualitative control results: a total of 93(4.2%) incorrect code readings were detected and 16(0.7%) readings for wrong components / wrong drugs. Explaining the results of quantitative control, 95 mixtures (4.3%) were prepared incorrectly -29(1.3%) due to an overdosage, and 66(3.0%) because of an underdosage. Conclusion: A new support technology was introduced to increase pharmacotherapeutic security in oncohematology, which successfully achieved the purpose in all stages of the process. In the study period, the implemented system successfully intercepted all the errors that could have reached the patient in 6.2% of the prescribed mixtures.

Introduction: Fluoroquinolones are most widely used for empirical treatment of gastrointestinal disease due to emergence of drug resistant strains to other antimicrobials. They are also indulged in cutaneous adverse drug reactions with varying form of severity. Case Presentation: A 43 year old male patient developed fixed drug eruptions after administration of tablet norfloxacin and metronidazole for the treatment of colicky abdominal pain with diarrhoea. Erythematous rashes involved whole body including buccal mucosa. Causative drugs were stopped and patient was managed by local as well as systemic therapy and was recovered after 20 days. Conclusion: Awareness among healthcare professionals regarding FDEs and its management is essential to prevent mortality and morbidity and counsel patient regarding future use of drugs causing reactions with physician’s advice.

Introduction: Cefixime, a third-generation cephalosporin, is commonly used in different infections. Tolerance is pretty good even if some side effects can be frequent like digestive disorders. Other effects, not mentioned in the Summary of Product Characteristics, can occur. Methods: We report a case of recurrent, acute oromandibular dystonia in a cefixime-treated adult. Case-report: After the third dose of cefixime, prescribed for a bronchial infection, a patient experienced a first episode of oromandibular dystonia. Then, after each ingestion, the same effects appeared. After the discontinuation of cefixime, there was no recurrence. The diagnosis of acute oromandibular dystonia has been confirmed by a neurologist. Discussion: Some cases of dystonia have been published with other β-lactams antibiotics and with cefixime but they concerned children. Different mechanisms are proposed to explain the occurrence of dystonia during a treatment with cefixime. They involved certain neurotransmitters like dopamine, acetylcholine or GABA. Conclusion: Even if dystonia is not a side effect mentioned in the SPC, the drug’s potential causal role must always be considered in case of involuntary contraction of muscles in a patient treated with cefixime or any other β-lactam antibiotics.

Background: Risperidone is an atypical ant ipsychotic agent that was originally approved by the United States Food and Drug Adminstration for the treatment of schizophrenia. There are many side effects that are frequently associated with the use of risperidone. These include weight gain, anxiety, extra-pyramidal side effects, and elevated prolactin levels. More infrequently, the use of risperidone has been linked to leukopenia. Objective: To describe the relationship between the administration of risperidone and the development of leukopenia in this patient. Method: We present the case of a 66-year-old gentleman who developed leukopenia after the initiation of risperidone to control agitation due to delirium. We will review the previous cases of leukopenia associated with risperidone, and will review possible risk factors for the development of leukopenia, based on the reported cases. Results: In this case, there was noted to be a close temporal relationship between the increase in risperidone dose and the rapid drop in white blood cell count. Conclusion: This patient's case supports the premise that patients may develop leukopenia after treatment with risperidone. The development of risperidone induced leukopenia may be more likely if the patient had a prior episode of leukopenia associated with the use of another antipsychotic agent.

Porphyria cutanea tarda (PCT) is the most common form of human porphyria, due to reduced activity of uroporphyrinogen decarboxylase (UROD). There are many factors which can trigger PCT such as viral infections, excessive alcohol intake, iron overload, hepatotoxic drugs and hepatic tumours. Drug induced PCT is well documented but PCT induced by interferon α has rarely been described and only in cases of Hepatitis C Virus (HCV) infection or haematological malignancies. Here, we report the first case of de novo PCT induced by adjuvant interferon α (IFNα) therapy in a patient with stage II melanoma.

Introduction: Multiple meningiomas growth in patients under cyproterone acetate (CPA) is now well known. However, time between initial CPA intake and diagnosis remains unclear. Methods: The exposure time differs in each reported case: from 2 to 10 years. We present the case of an old man with acute visual impairment caused by an unusual bilateral optic nerve compression by three likely planum sphenoidale meningiomas rapidly induced by the admistration of CPA for prostatic adenocarinoma. Results and Conclusion: This case is the first reported with a short exposure time (7 months) to CPA treatment before diagnosis of multiple meningiomas and stabilization on clinical follow-up after CPA treatment discontinuation.

Introduction: Thalidomide, previously banned owing to the issues of teratogenicity is being used and tested for a variety of dermatological and non dermatological conditions. The drug has been approved for the management of erythema nodosum leprosum [ENL] and multiple myeloma [MM]. The drug is commonly known to produce adverse effects like peripheral neuropathy and constipation. Deep vein thrombosis [DVT] is one of the serious adverse effects seen with thalidomide use, especially in malignancies and is relatively uncommon in non cancer settings like ENL. Method: Here we report a case of DVT occurring after 8 months of use of thalidomide in a young patient of 22 years age suffering from ENL. Result: The case highlights the problems faced in the management of refractory ENL and the treatment of DVT in the setting of multiple drug interactions and financial constraints. Conclusion: New guidelines are required regarding the prophylaxis and management of DVT associated with thalidomide use in non-malignant conditions.