Preview

Safety and Risk of Pharmacotherapy

Advanced search
Vol 6, No 3 (2018)
View or download the full issue PDF (Russian)
https://doi.org/10.30895/2312-7821-2018-6-3

ORIGINAL ARTICLES

103-110 10525
Abstract

The article reviews the literature on classical and atypical Reye’s syndrome, explores the circumstances that contribute to its  occurrence, provides criteria for diagnosing with an illustration in the form of an authentic case of Reye-like disease in a child of 3 years  old. Reye’s syndrome is a disease manifested by acute  encephalopathy in combination with fatty degeneration of the  internal organs, mainly the liver. This condition was first described in  1963 by an Australian pathologist who identified 21 cases of the  disease in children with influenza A who were taking acetylsalicylic  acid, 17 children died. In the future, the circle of infections that  preceded the development of Reye’s syndrome-acute respiratory  infections, chickenpox, entero- and rotavirus infections, in rare  cases, hepatitis A and HIV, bacterial infections: mycoplasma,  chlamydia, whooping cough, shigella, salmonella. Drugs that can cause the development of this syndrome: tetracycline,  zidovudine, diclofenac sodium, mefenamic acid, paracetamol,  amiodarone, warfarin, phenothiazine derivatives, histaminolytics  (dimedrol), valproic acid. Along with drugs, insecticides, herbicides,  hepatotoxic fungi can be used as triggers of the syndrome. There is  an age dependence of the development of this syndrome. The  pathogenesis of classic Reye’s syndrome is associated with  generalized damage to the mitochondria primarily in the brain, as well as in the liver, kidneys, muscles, myocardium and pancreas,  with the disturbance of oxidation of fatty acids in them and the  formation of fat degeneration of varying degrees. In addition to the  classic Reye’s syndrome, atypical Reye’s syndrome or Reye-like  disease is isolated, occurs in children under 5 with congenital  disturbance of oxidation of fatty acids. We observed in our clinic the  case of Reye-like disease in a girl of three years with infection and  taking antipyretics. In the discussion section, the features of the  given case are noted, the question of the appropriateness (in view of the generality of the clinic and the mechanisms of development) of  dividing the syndrome into classical and atypical is discussed. A new  name for both conditions is proposed — Reye’s disease in honor of  the discoverer, highlighting its two forms with an early and late  onset. Given the morphological changes in this syndrome —  steatosis of internal organs — authors seem to be appropriate  measures aimed at treating secondary mitochondrial insufficiency  and fatty dystrophy.

111-117 1353
Abstract

Human papillomavirus refers to DNA-containing viruses and infects the skin and mucosal epithelium. One common way is to change the  expression of cellular genes by integrating the viral genome into  cellular DNA. The reason for the resistance of HPV infection is the  presence of complex mechanisms of inhibiting the immune response  of the macroorganism. An important infectious agent involved in  carcinogenesis are human papillomavirus (HPV) viruses, which cause  a significant part of oncological diseases. Viruses create the  prerequisites for malignant cells by introducing an oncogene or  blockade of suppressor proteins in cells to disrupt the regulation of  cell division. Two proteins, E6 and E7, encoded by the DNA of the  virus, play a leading role in this process. More than 100 different types of HPV have been identified, and approximately one- third of them infect epithelial cells in  the genital tract. HPV is also  the cause of carcinoma of the penis, vulva, anus and contribute to  the occurrence of more than 40 % of oropharyngeal cancer. To date,  the most effective way to combat HPV infection is  immunoprophylaxis. To date, there are three commercially available  HPV vaccines: Cervarix®, Gardasil®, Gardasil®9. These three  vaccines effectively prevent HPV infections, causing the production of neutralizing antibodies that bind to viral particles and block their  entry into host cells. However, these vaccines are not effective in  eliminating pre-existing infections. Currently, there are no  therapeutic vaccines against HPV, approved for use in humans. The  review discusses the types of vaccines against HPV infection and the effectiveness of vaccination.

118-122 5132
Abstract

Myopathy is a life-threatening disease that can be caused, among other things, by the intake of various medications. Despite the fact  that many drug-induced myopathies are well known, however, many  health professionals are not alert to myopathies caused by drug  interactions. Myopathy is a wellknown adverse reaction of statins,  and muscle damage can range from minor muscle pain and  weakness to life-threatening rhabdomyolysis. Colchicine can also  cause myopathy, including rhabdomyolysis. The combination of  colchicine and statins can significantly increase the risk of myopathy  compared with their intake separately. In cases of development of  myopathy in patients receiving colchicine and statins simultaneously, the most common manifestation of drug interaction was muscle  weakness, occurring in almost every case, and in some cases,  muscle weakness was so severe that the patient lost the ability to  move. In a third of cases, the development of muscle weakness was  accompanied by muscular pain, and darkening of urine to tea shade.  One study showed that 40 % of patients received concurrent combinations of drugs that increased the risk of muscle  damage. It is concluded that the simultaneous administration of  colchicine and statins requires an assessment of the “benefit-risk”  ratio, as well as the administration of drugs in minimally effective doses.

123-129 2011
Abstract

Non-steroidal anti-inflammatory drugs (NSAIDs) are liders in selling both in the Russian Federation and worldwide. The combination of  analgesic, anti-inflammatory and antipyretic effects make the drugs  of this group very popular in patients with various diseases. The  realization of NSAIDs in pharmacies occurs both by prescription and  over-the-counter, so the safety assessment of the use of this group  of drugs remains relevant. In the current practice, self-administration (responsible selfmedication) of drugs of the NSAID  group is an additional factor affecting the safety of their intake. According to the studies, about 40 % of patients taking  NSAIDs consider that NSAIDS are absolutely safe, and more than 30  % of those taking OTC NSAIDs use them in excess of the  recommended dosages. We analyzed 3963 individual case safety  reports (ICSR) in the federal database «Pharmacovigilance» from  07.12.2008 to 31.08.2017. The inclusion criterions was the presence of information on the off-label application of NSAIDs in the ICSR,  reports of adverse effects that may be associated with the use of this drug or erroneous reports on the active substance, which was  not present in this drug. The most frequent mistakes in the  application were an increase of the daily dose, a change in the  method of administration to patient who are contraindicated with this drug. There were 9 ICSR of burning sensation in the anus with the  introduction of ibuprofen suppositories (not in the label), and 7 ICSR  of ineffectiveness of the active substance, which was not present in this drug.

RELEVANT INFORMATION

 
130-137 2432
Abstract

The monitoring of information on the safety of various drugs is becoming more relevant day by day, as the number of drugs on the  pharmaceutical market increases, generic drugs, bio-analogous drugs appear. Long-term post-marketing use of a  medicinal product allows to accumulate a sufficient evidence base  and experience of application in various population groups, to study  the features of the use of this drug. Information on the safe use of  new drugs can be obtained in selected scientific publications. In  addition to publications in the specialized scientific literature,  regulators of different countries on the basis of new information give opinions on the need to make changes in instructions for medical  use. When analyzing the recommendations of Russian and foreign  regulatory authorities on restricting the circulation of medicines and  / or the need to amend the instructions for their medical use in  connection with the change in the assessment of the safety profile,  we identified 16 administrative decisions of foreign regulatory bodies containing information about the following drugs registered in  Russia. We consider all recommendations to be important  information on the safety of medicines, which is addressed to  specialists in the field of medicine, in particular to persons  authorized by pharmacovigilance in pharmaceutical companies. In  addition, this information may be of interest to physicians of various  specialties who in their practice use buprenorphine, venlafaxine,  gadolinium contrast drugs hydroxyethyl starch, daclizumab,  duloxetine, denosumab, cladribine, clomifene citrate, milnacipran, methotrexate, pemetrexet, radium dichloride, rifampicin,  phoebusostat, flupirtine. 

OTHER



Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2312-7821 (Print)
ISSN 2619-1164 (Online)