Background Telaprevir is one of the new drugs for chronic hepatitis C genotype 1. As it is a new drug is necessary to be aware of the emergence of new adverse reactions that may not be included in the SPC. Purpose To investigate possible severe adverse reactions not mentioned in telaprevir’s SPC. Materials and methods Descriptive and retrospective clinical case. Data were obtained by review of the patient medical history, Savac and Selene software and laboratory data. Results Fifty-seven-year-old male with HCV genotype 1a/1c. It was decided to start his first treatment for hepatitis C with ribavirin (RBV) 400 mg/12 h, Peg-interferon (P-INF) alfa 2a 180 mcg/week and telaprevir 750 mg/8 h. In week 8 of treatment he was admitted with symptomatology compatible with pancreatitis. Amylase 1888 IU/L appeared in laboratory data. Absolute diet, analgesic and antiemetic measures were established. The patient was discharged a week after admission with an amylase of 173 IU/L. The next day he was admitted with an amylase of 3406 IU/L and the same symptoms. Telaprevir was suspended (week 9 of treatment) in case it could be the cause, and he continued with P-INF and RBV. The patient was discharged 5 days later with an amylase of 365 IU/L. The Karch-Lasagna modified algorithm established as “possible” the relationship between pancreatitis and telaprevir. Conclusions A MEDLINE search was performed on 17.01.13 with the words “telaprevir” “pancreatitis” “abdominal pain” or “amylase” and we did not find any results that evidenced pancreatitis caused by telaprevir. A temporal association existed between drug use and pancreatitis symptoms as well as between telaprevir suspension and the patient’s improvement. Therefore, we concluded that telaprevir could have caused acute pancreatitis in this patient. No conflict of interest.
Background Eribulin is a new drug against metastatic breast cancer, one of the most common cancers in women Purpose To study the effectiveness and safety of treatment with eribulin in metastatic breast cancer in patients who have been treated with at least two processing lines including anthracyclines and taxanes Materials and methods Retrospective descriptive study of patients who received eribulin from marketing until September 2013. Variables examined: sex, age, hormone receptor and lines of treatment prior to HER-2, progression-free survival (PFS) and adverse reactions (RA). Source of data: history and pharmaceutical validation program Farmis-Oncofarm. Results We included 26 female patients with a median age of 57 years, 22 (84.6%) hormone-sensitive and 20 (77%) HER-2 negative. Median prior lines of treatment were 5. Of the 26 patients, 23 had previously been treated with capecitabine, and drug median PFS was 140 days. The median number of eribulin cycles received was 6 and the median PFS was 137 days (range 31–663 days). Regarding safety, 18 (61.5%) patients experienced 36 RA Grade 1 or 2 and 6 grade 3 or 4 (G3/G4). The RA found were: asthenia 10 (1 G3/4), gastrointestinal disorders 10 (2 G3/G4), neuropathy 4 (1 G3/G4), anaemia 4 (1 G3/G4), skin disorders and/or alopecia 4 (1 G3/G4), neutropenia 3 and liver disorders 1 G3/4. Five patients had their dose reduced to 0.97 mg/m2. All patients received prophylactic G-CSF to reduce hematologic toxicity. Conclusions In the EUPHORIA study (presented in ASCO 2013). 104 patients were treated (64.4% hormone-sensitive). The median PFS was 97 days (3 months) With regard to the most frequent adverse reactions were similar to those in this study. The effectiveness results obtained in this study are consistent with those reported in the pivotal clinical trials (133 days, 3,8 months). The PFS of EUPHORIA study may be lower because the lower rate of hormone-sensitive patients. Moreover, the patients who have been treated with capecitabine and eribulin exhibit similar PFS. Given the effectiveness and safety of the drug, treatment should be evaluated with other cytostatic drugs with better cost-effectiveness profile-security such as capecitabine. No conflict of interest.
Background Autologous serum eye drop treatment is a common practice in the treatment of several ocular pathologies that require relatively frequent blood draws. Purpose To study the symptom improvement perceived by patients after treatment with autologous serum 20% and overall satisfaction with such treatment. Materials and methods Observational, retrospective and descriptive study in eye disease patients (GVHD, dry eye, etc.) with autologous serum 20% eye drops in 2011 and 2012. The information was compiled by the SAVAC and SELENE prescribing systems and reviewing medical records in addition to telephone surveys of patients. Reviewed symptoms were: red eye, dry eye, inflammation, rheum, foreign body, itching/burning, tearing, photophobia, blurred vision and eye heaviness. Results A total of 15 patients (53% male) with a median age of 58 years were studied, of whom 11 (73%) had red eye, 13 (87%) dry eye, 6 (40%) inflammation, 5 (33%) rheum, 11 (73%) foreign body, 14 (93%) itching/burning, 1 (7%) tearing, 13 (87%), photophobia, 10 (67%), blurred vision, 5 (33%) eye heaviness. Of patients who experienced these symptoms, 64% of patients with red eye, 46% with dry eye, 50% with inflammation, 80% with rheum, 82% with foreign body, 64% with itching/burning, 15% with photophobia, 50% with blurred vision and 40% with eye heaviness considered they had improved and the tearing-eyed patient did not improve. Conclusions Symptoms that improved in a greater number of patients were sensation of foreign body, itching/burning eye and red eye. On the other hand, some symptoms such as photophobia, tearing and dry eye improved in only a small number of patients. Furthermore, 80% of patients said the perceived subjective improvement in symptoms was worthwhile, compared to the discomfort of blood draws. No conflict of interest.
BackgroundOndansetron is a powerful and highly selective serotonin receptor antagonist used to prevent nauseas and vomiting after surgery or chemotherapy. Sialadenitis consists in the formation of stones along the salivary duct.PurposeTo describe a case of ondansetron-induced sialadenitis and the prevention of its reappearance.Material and methodsData obtained from the medical records and direct interview with the patient, were: age, sex, pathology, concomitant drugs and resolution. Side effects and interactions of each drug were obtained from the product information and Micromedex.ResultsA 28-year-old woman in treatment with temozolomide for a low-grade astrocytoma, sought help in her third cycle of chemotherapy for obstruction of the salivary duct.The patient was taking escitalopram and levetiracetam. Temozolomide, ondansetron and dexamethasone had been recently introduced, so they were the most likely agents to have caused the event.In the list of possible adverse effects of every agent, sialadenitis is not referenced but xerostomia is described in the information about ondansetron (5%) and escitalopram (4–9%) and it could have worsened with the vomiting and dehydration.Studying the interactions between the drugs did not warn us. The mechanism of action of ondansetron over the 5-HT4 receptor can explain it. Some antidepressants block cholinergic receptors contributing to this situation but escitalopram has a very low effect over them, the reaction was unexpected.The Naranjo algorithm assigned 5 points (likely) to both as the causative agents but there are no previous notifications of this adverse event.The stone dissolved spontaneously after oral hydration and the salivary duct became milky. The pharmacist instructed the patient in correct oral hydration and the event did not occur again during the next 12 months of treatment.ConclusionHigh dose of ondansetron added to escitalopram may cause salivary duct stones in patients with other risk factors such as vomiting and dehydration. The pharmacist can prevent new stones from appearing by teaching patients good oral hydration practices during treatment.ReferenceNo conflict of interest.
BackgroundSome patients directly hospitalised via the emergency department are changed from their current home treatment. The pharmacy department aims to identify any errors and rectify them.PurposeTo find out how many home treatment prescriptions could lead to an error in patients hospitalised by the emergency medical service.To identify any issues and analyse them.Material and methodsProspective observational study. 366 Patients hospitalised from January 2014 were followed.The analysis included: medicines prescribed 48 h after admission, age, gender, team on duty and problems related to the home treatment. We classified the issues found as:Treatment not followed at allTreatment partially followed.Patient’s previous medicines not stated.Patient’s previous medicines stated incorrectly.Illegible writing.Data source: Savac (prescription and clinical history records), Selene (specialist care medical history records).Results366 consultant prescriptions were analysed. 30% of them were for a home treatment.Patient characteristics: Males: 51%; 85% of the patients were over 60 years; the Internal Medicine ward had the highest number of admissions, 32%; 4.7% of the patients had problems related to home treatmentBased on our classification of the issues found to do with home treatment, the following frequencies were obtained:Type 1: 31.5%;Type 2: 6.25%;Type 3:37.5%Type 4:18.7%;Type 5: 6.25%ConclusionIssues related to home treatment were identified in 4.7% of the patients.The most common issue was type 3: Patient’s previous medicines not stated.The ward with the highest number of issues detected was the orthopaedic surgery department.ReferenceTomás S, Chanovas M, Roqueta F, Alcaraz J, Toranzo T, Grupo EVADUR-SEMES. EVADUR: eventos adversos ligados a la asistencia en los servicios de urgencias de hospitales españoles. Emergencias 2010;22:415–28No conflict of interest.
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