Untoward side effects of psychiatric drugs

2017 ◽  
Author(s):  
Manu S. Sharma ◽  
Ives Cavalcante Passos ◽  
André F. Carvalho
Keyword(s):  
Adverse Effects ◽  
Psychotropic Medications ◽  
The Body ◽  
Post Marketing Surveillance ◽  
Long Term Follow Up ◽  
Post Marketing ◽  
Metabolic Conditions ◽  
Life Threatening

Adverse effects are an unavoidable risk of medication treatment. Clinical trials alone do not adequately assess the entire side effect profile, and it is important to pay attention to post-marketing surveillance and long-term follow up studies. Psychotropic medications are responsible for a wide variety of adverse effects, which can affect almost any part/system of the body. Adverse effects can vary from mild nausea and vomiting to life-threatening blood dyscrasias and arrhythmias. A high number of adverse effects are associated with the action of the psychotropic medications on their primary targets outside the brain, and the additional action on the autonomic nervous system. In order to minimize the risk of adverse effects most psychotropic medications should be started with low-dose trials followed by slow titration. Care should be taken to look for drug-drug interactions and pre-existing medical and metabolic conditions which may pre-dispose a patient to certain adverse effects.

scholarly journals Factors affecting the course of body and kidney growth in infants with urolithiasis: A critical long-term evaluation

2016 ◽  
Vol 88 (4) ◽  
pp. 249 ◽  
Author(s):  
Kemal Sarica ◽  
Fatma Narter ◽  
Kubilay Sabuncu ◽  
Ahmet Akca ◽  
Utku Can ◽  
...  
Keyword(s):  
Breast Feeding ◽  
Clinical Course ◽  
Stone Disease ◽  
The Body ◽  
Renal Growth ◽  
Related Factors ◽  
Growth Status ◽  
Long Term Follow Up

Objective: To investigate the possible effects of dietary, patient and stone related factors on the clinical course of the stone disease as well as the body and renal growth status of the infants. Patients and Methods: A total of 50 children with an history of stone disease during infancy period were studied. Patient (anatomical abnormalities, urinary tract infection - UTI, associated morbidities), stone (obstruction, UTI and required interventions) and lastly dietary (duration of sole breast feeding, formula feeding) related factors which may affect the clinical course of the disease were all evaluated for their effects on the body and renal growth during long-term follow-up. Results: Mean age of the children was 2.40 ± 2.65 years. Our findings demonstrated that infants receiving longer period of breast feeding without formula addition seemed to have a higher rate of normal growth percentile values when compared with the other children. Again, higher frequency of UTI and stone attacks affected the growth status of the infants in a remarkable manner than the other cases. Our findings also demonstrated that thorough a close follow-up and appropriately taken measures; the possible growth retardation as well as renal growth problems could be avoided in children beginning to suffer from stone disease during infancy period. Conclusions: Duration of breast feeding, frequency of UTI, number of stone attacks and stone removal procedures are crucial factors for the clinical course of stone disease in infants that may affect the body as well as kidney growth during long-term follow-up.

Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Post Marketing Surveillance Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
P Value ◽  
End Of Treatment ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

scholarly journals Aorto-esophageal fistula: successful open surgical management of two cases

2020 ◽  
Vol 2020 (6) ◽  
Author(s):  
Siddharth Pahwa ◽  
Susmit Bhattacharya ◽  
Siddhartha Mukhopadhyay ◽  
Ashok Verma
Keyword(s):  
Surgical Management ◽  
Surgical Repair ◽  
Hemodynamic Instability ◽  
Esophageal Fistula ◽  
Long Term Follow Up ◽  
Life Threatening ◽  
Dacron Patch ◽  
Upper Gastrointestinal

Abstract An aorto-esophageal fistula (AEF) is a rare yet life-threatening cause of upper gastrointestinal bleeding. We report our experience with open surgical management of two cases of AEF. Both cases presented with almost identical presentations: hematemesis and hemodynamic instability. The aorta in the first patient was normal; the defect was small and was repaired with a Dacron patch. The second patient had an aneurysmal aorta, which was replaced with a Dacron graft. Both cases were performed under partial bypass. The esophageal rent in both patients was debrided, primarily closed and buttressed with a vascularized intercostal pedicle. Nonavailability of endovascular personnel and equipment along with hemodynamic instability of the patient influenced our surgical strategy. Long-term follow-up of these patients is necessary to analyze the outcomes of our surgical repair.

scholarly journals Coronaric Stent-Graft Deployment in the Treatment of Carotid Blowout

2011 ◽  
Vol 17 (4) ◽  
pp. 490-494 ◽  
Author(s):  
E. Pampana ◽  
R. Gandini ◽  
M. Stefanini ◽  
S. Fabiano ◽  
A. Chiaravalloti ◽  
...  
Keyword(s):  
Stent Graft ◽  
Clinical Results ◽  
Covered Stent ◽  
Endovascular Stent Graft ◽  
Carotid Blowout Syndrome ◽  
Rescue Treatment ◽  
Long Term Follow Up ◽  
Life Threatening

“Carotid blowout syndrome” is defined as a hemorrhage caused by rupture of the carotid artery and its branches, and may be a severe complication of rhinopharyngeal carcinoma. This study aimed to highlight the usefulness and versatility of endovascular stent-graft placement as a rescue treatment in life-threatening carotid blowout syndrome. We describe the unconventional use of a 6×5 mm balloon-expandable coronaric covered stent in a patient with a diagnosis of spinocellular rhinopharyngeal carcinoma, followed by carotid blowout syndrome. Although long-term follow-up is needed to assess the eventuality of bleeding recurrence, the immediate clinical results were satisfactory.

scholarly journals Ultrasound-tailored functional hemispherectomy for surgical control of seizures in children

1996 ◽  
Vol 1 (5) ◽  
pp. E4
Author(s):  
Paul M. Kanev ◽  
Catherine M. Foley ◽  
Dan Miles
Keyword(s):  
The Body ◽  
Temporal Lobectomy ◽  
Surgical Time ◽  
Postoperative Fever ◽  
Intractable Seizures ◽  
Functional Hemispherectomy ◽  
Fever Syndromes ◽  
Long Term Follow Up

Functional hemispherectomy techniques have been designed to minimize the long-term complications of anatomical resection without reducing the effectiveness of seizure control. The authors have used an ultrasound-guided approach tailored to combine temporal lobectomy with frontal and occipital disconnections with a central topectomy of the lateral, insular, and interhemispheric cortex. This technique achieves a comprehensive functional disconnection and minimizes entrance and manipulation within the body of the lateral ventricle. Eight patients ranging in age from 10 months to 23 years with congenital paresis and medically intractable seizures underwent functional hemispherectomy via this technique. The average surgical time was 4.5 hours, and blood loss ranged from 90 to 400 ml. All but one patient was discharged after 5 days. Postoperative fever syndromes, aseptic meningitis, and infection were avoided. On long-term follow-up evaluation (range l8-60 months, mean 38 months), seven of eight patients remain seizure free and were not on a course of anticonvulsant agents. Advantages of this technique include avoiding entrance within the ventricle, a more predictable postoperative period, and reduced postoperative complications.

Pets and Health

1998 ◽  
Vol 83 (3) ◽  
pp. 1011-1024 ◽  
Author(s):  
James Robert Brasić
Keyword(s):  
Adverse Effects ◽  
Objective Assessment ◽  
Wide Range ◽  
Follow Up Studies ◽  
Long Term Follow Up

Beneficial and adverse effects of pets for individuals in a wide range of circumstances have been reported. Nevertheless, well-designed unbiased experiments and long-term follow-up studies are needed. Pets appear to be therapeutic for some individuals and deleterious for others. The controversies concerning the effects of pets on health merit objective assessment by unbiased researchers.

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