DOI: https://doi.org/10.18370/2309-4117.2018.44.64-70

Safety of drugs

А. А. Суханова, Ю. Н. Мельник, А. Б. Гордийчук

Abstract


Liver is the main organ that plays an important role in the biotransformation of medicine in human body. Therefore, drug-induced liver injuries are much more common than official medical statistics show in different countries and on different continents. This circumstance is associated with many factors: the latent course of drug-induced liver injuries, inadequate interpretation of clinical symptoms and clinical laboratory parameters, insufficiently careful investigation of anamnesis, different frequency of use of various medicine in different countries.

Drug-induced liver injuries are lesions that are associated with the use of medicine. Drug-induced liver injuries must be diagnosed as early as possible, as the continued administration of medicine can repeatedly exacerbate the severity of clinical manifestations and significantly affect the outcome of the disease as a whole. In addition, legal aspects are also important in this regard, since an unrecognized drug-induced liver injury with continued use of this medicine that allegedly caused this injury is a matter of a frequent professional investigations.

The reaction of the liver on medicine depends on many factors: the initial state of liver function (already existing liver disease), heredity, gender, age, alcohol intake and other medicine. Presence of these factors in patients significantly increases the risk of development of liver injuries associated with taking medications, and if the drug-induced liver injury develops, the prognosis of its course will be heavier. Statistically-valid are frequent drug-induced liver injuries in women. The same type of medicine can cause different types of liver injuries in terms of clinical and morphological manifestations. Diagnostics of drug-induced liver injury is often difficult and requires from a specialist certain skills not only the necessity to carefully collect an anamnesis of a patient with a developed disease, but also a good orientation in his clinical and morphological manifestations.


Keywords


liver damage; alanine aminotransferase; aspartate aminotransferase; liver enzymes; acute hepatitis; chronic hepatitis

References


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GOST Style Citations


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3.           Aithal, G.P., Watkins, P.B., Andrade, R.J., et al. “Case definition and phenotype standardization in drug-induced liver injury.” Clin Pharmacol Ther 89 (2011): 806–15.

4.           Bjornsson, E., Talwalkar, J., Ttreeprasertuk, S., et al. “Drug-induced autoimmune hepatitis: clinical characteristics and prognosis.” Hepatology 51 (2010): 2040–8.

5.           Chalasani, N.P., Ayashi, P.H., Bonkovsky, H.L., et al. “ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury.” Am J Gastroenterol 109 (2014): 950–66.

6.           Chen, M., Susuki, A., Thakkar, S., et al. “The largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.” Drug Discov Today 21 (2016): 648–53.

7.           De Abajo, F.J., Montero, D., Madurga, M., García Rodríguez, L.A.

“Acute and clinically relevant drug-induced liver injury: a population based case-control study.” Br J Clin Pharmacol 58 (2004): 71–80.

8.           De Valle, M.B., Av Klinteberg, V., Alem, N., et al. “Drug-induced liver injury in a Swedish University hospital out-patient hepatology clinic.” Aliment Pharmacol Ther 24 (2006): 1187–95.

9.           Donnez, J., Dolmans, M.M. “Uterine fibroid management: from the present to the future.” Hum Reprod Update 22 (2016): 1–22.

10.         Donnez, J., Donnez, O., Matule, D., et al. “Long-term medical management of uterine fibroids with ulipristal acetate.” Fertil Steril 105 (2016): 165–73.

11.         Donnez, J. “Liver injury and ulipristal acetate: an overstated tragedy?” Fertil Steril 110.4 (2018): 593–5. DOI: 10.1016/j. fertnstert.2018.06.044

12.         European Association for Stud of Liver. “EASL Clinical Practice Guidelines: Wilson’s disease.” J Hepatol 56 (2012): 671–85.

13.         Fauser, B.C.J.M., Donnez, J., Bouchard, P., et al. “Safety after extended repeated use of ulipristal acetate for uterine fibroids.” PLoS One 12 (2017): e0173523.

14.         FDA Working Group. CDER-PhRMA-AASLD Conference 2000. Clinical white paper on drug-induced hepatotoxicity. FDA (2000).

15.         Lammert, C., Einarsson, S., Saha, C., et al. “Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury: search for signals.” Hepatology 47 (2008): 2003–9.

16.         Lee, W.M. “Acute liver failure in the United States.” Semin Liver Dis 23 (2003): 217–26.

17.         Lewis, J.H. “The adaptive response (drug tolerance) helps to prevent drug-induced liver injury.” Gastroenterol Hepatol (NY) 8 (2012): 333–6.

18.         Marrone, G., Vaccaro, F.G., Biolato, M., et al. “Drug-induced liver injury 2017: the diagnosis is not easy but always to keep in mind.” European Review for Medical and Pharmacological Sciences 21 Suppl 1 (2017): 122–34.

19.         National Institute for Health and Care Excellence. Heavy menstrual bleeding: assessment and management. Clinical guideline [CG44] (2018).

20.         Ostapowicz, G., Fontana, R.J., Schiodt, F.V., et al. “Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States.” Ann Intern Med 137 (2002): 947–54.

21.         Robles-Diaz, M., Garcia-Cortes, M., Medina-Caliz, I., et al. “The value of serum aspartate aminotransferase and gamma-glutamyl transpetidase as biomarkers in hepatotoxicity.” Liver Int 35 (2015): 2474–82.

22.         Sgro, C., Clinard, F., Ouazir, K., et al. “Incidence of drug-induced hepatic injuries: a French population-based study.” Hepatology 36 (2002): 451–5.

23.         Suzuki, A., Brunt, E.M., Kleiner, D.E., et al. “The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis versus drug-induced liver injury.” Hepatology 54 (2011): 931–9.

24.         Vuppalanchi, R., Liangpunsakul, S., Chalasani, N. “Etiology of new-onset jaundice: how often is it caused by idiosyncratic drug-induced liver injury in the United States?” Am J Gastroenterol 102 (2007): 558–62.

25.         Yoon, E., Babar, A., Choudhary, M., et al. “Acetaminophen-induced hepatotoxicity: a comprehensive update.” J Clin Transl Hepatol 4 (2016): 131–42.

26.         Zimmerman, H.J.; U.S. DHHS, FDA, CDER, CBER. Guidance for industry drug-induced liver injury: premarketing clinical evaluation. USDHHS, FDA, CDER, CBER (2009).

27.         Zimmerman, H.J. Hepatotoxicity: the adverse effectsof drugs and other chemicals on the liver. New York. Appleton-Century-Crofts (1978).





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