PREVENTABLE DRUG HARMS IN HEPATOBILIARY SYSTEM, A

PROSPECTIVE OBSERVATIONAL STUDY IN OPD & IPD PATIENTS OF

MEDICINE DEPARTMENT FROM CIVIL & PRIVATE HOSPITAL, NASIK
Desle RS, Khairnar A*
University Department of Health Sciences, Maharashtra University of Health Sciences,
Nasik
Abstract
Hepatotoxicity is a potential adverse effect for commonly prescribed drugs & Liver is the main
organ for metabolism of drugs therefore it is susceptible to high degree of toxicity. This study
was done to study the frequency of drug induced liver injury and to find the common drugs
causing hepatotoxicity. The study was conducted at Medicine Department from Civil & Private
Hospital Nasik. This study was based on case series analysis. All patients with abnormal liver
function reports were included in study. As it was a long term study therefore not possible to
recruit all drug induced liver injury patients in shorter time period. Our total sample size is 180
out of which 70 (38.88%) patients were recruited within given time line. Out of total 70 Patients
46 were male (65.71%) & 24 were female (34.29%). The mean age of the patients with drug
induced liver injury was 40.44 years Non steroidal anti-inflammatory drugs were commonly
encountered drugs (24.29%) causing hepatotoxicity followed by antibiotics (20%). Other drugs
included antitubercular drugs (11.43%), antimalarial drugs (10%), highly active anti-retroviral
therapy drugs (5.71%), immunosuppressants (5.71%). In Most of the cases reported adverse
drug reaction were probably preventable 43(61.42%) where as defiantly preventable were
8(11.42%) and remaining were not preventable 19(27.14%). Non steroidal anti-inflammatory
drugs were most common hepatotoxic drugs.
Keywords: Drug induced liver injury, Hepatotoxicity, Non-steroidal anti inflammatory drugs,
Antitubercular drugs, Highly active anti-retroviral therapy.

*Corresponding author:
Khairnar A
University Department of Interpathy Research and Technology
Maharashtra University of Health Science,
Nasik, Maharashtra
Email: avinashkhairnar@gmail.com

Introduction:
An adverse drug reaction is an expression that describes harm associated with the use of given
medications at a normal dose1. In the United States, more than 100,000 deaths are attributed
annually to serious adverse drug reactions 2. 3 to 6 percent of all hospital admissions are because
of adverse drug reactions, and 6 to 15 percent of hospitalized patients (2.2 million persons in the
United States in 1994) experience a serious adverse drug reaction3, 4.
DILI can be defined as a liver injury induced by a drug or herbal medicines leading to
liver test abnormalities or liver dysfunction with reasonable exclusion of other competing
etiologies. Drug-induced liver injury (DILI) is a common liver disease which generally occurs
between 5 and 90 days after drug ingestion 5. Most cases of DILI are due to idiosyncratic or
unexpected reactions. In contrast to paracetamol induced hepatotoxicity, which occurs with dosedependent overdose of the drug, idiosyncratic drug reactions have been traditionally considered
dose independent. Drug-induced liver injury (DILI) caused by idiosyncratic drug reactions is in
most cases detected in a patient with mild to moderate elevations of liver tests, but can in rare
cases lead to fatal hepatic necrosis6, 7.
Studies before the release of a drug are usually underpowered to detect rare side effects
such as DILI and the information on these is usually obtained in the post marketing phase 8. The
real incidence of DILI remains unknown because of the difficulty in establishing diagnosis and
the low reporting frequency to the Pharmacovigilance authorities. Only one prospective
population based study has been undertaken in France till now to know the incidence of DILI
which revealed incidence of 13.9 per 100000 inhabitants, result of this study was considered as
gold standard for DILI9. From UK & Sweden also some prospective studies comes which shows
incidence rate of 2-3 cases per 100000 inhabitants per year which is negligible 10. Acute hepatic
injury resulting from drugs has been reported to occurs in 2-10% of patient hospitalize for
jaundice11.
Adverse drug reactions are an important cause of liver injury that may require
discontinuation of the medicines, hospitalization, or even liver transplantation12. Drug-induced
hepatotoxicity is the most frequent cause of acute liver failure, because the liver is responsible
for concentrating and metabolizing a majority of medications, it is a prime target for medicationinduced damage13.
The aims of the present study were to find out the frequency of DILI and to find the common
drugs causing hepatotoxicity. Depending on the duration of injury and the histological location of
damage, drug-induced liver injury (DILI) is categorized as acute or chronic, and either as
hepatitis, Cholestatic, or a mixed pattern of injury. A broad range of different pharmacological
agents can induce liver damage, including anticancer drugs, antibiotics, antituberculosis agents,
antiretrovirals, and cardiac medications. In addition, a traditional medical therapies and herbal
remedies may also be hepatotoxic.

Materials and Methods:

Study was conducted in compliance with the protocol, ICH GCP, ICMR, Schedule Y guidelines
and Indian regulatory requirements. This study was carried out in civil hospital and Private
hospital, Nasik. Approval from Independent Ethics Committee was taken prior to initiation of the
study. It was the prospective observational study based on case series analysis.
Signed dated written informed consent was taken from all subjects after providing them with
patient information sheet and informed consent form before screening. Total sample size was 180
but within given time period it is not possible to complete the study, so 70 patients were recruited
in study. All 70 patients had abnormal liver function test among these 46 were males & 24 were
females. Total 70 subjects and their prescriptions in which 50 subjects was from medicine
department of Civil hospital, Nasik and 20 was from private hospital, Nasik, all patients of
abnormal liver function test was included in study. Screening of subjects was done according to
inclusion and exclusion criteria with help of screening form and subjects were enrolled in study.
To identify DILI liver function test reports was screened having total bilirubin more than 1mg/dl
or PT-INR more than 1.5 were included in study. DILI is categorized either as hepatitis,
Cholestatic, or a mixed pattern of injury; also injuries are classified as mild, moderate and severe
as per severity criteria. For the causality assessment WHO scale was used. Patients were
analyzed for age, gender, history of drug intake. All the data were recorded on Case Record
Form which is specially design for the study. Data analyzed using descriptive statistics.

RESULT:
It was the Prospective observational study carried out in civil hospital and Private hospital, at
Nasik. Informed consent document was obtained from all patients enrolled in study. Over a
period of 2 months total 70 patients are suspected for drug induced liver injury. In which
50(71.42%) patients were from civil hospital & 20(28.57%) patients from Private hospital. All 70
patients had abnormal liver function test, among these 46(65%) were males & 24(35%) were
females. [fig. 1]
The mean age of all the patients was 40.44 + 4.24 years. Mean age for male was 39.63 + 4.24
and for female was 42 + 19.09 years (range from 18- 60 years). Drug induced liver injury was
more common in males. [fig. 2] In this study we have found mainly three types of patterns of
liver injury Hepatic, Cholestatic and Mixed. First one was Hepatic injury which accounts for 32
(45.7%) cases second one was Cholestatic injury which accounts for 6 (8.6%) cases and last one
was mixed type of injury which accounts for 32 (45.7%) cases of DILI. In our study mixed and
hepatic type of injuries are found equally while Cholestatic type was found in very few cases.
[fig. 3]
In our study we found that following some drugs were commonly prescribed, which was
responsible for causing drug induced liver injury. NSAIDS were 25% causing hepatotoxicity
which includes drugs like Nimesulide, Diclofenac, Ibuprofen & Naproxen. After that Antibiotics
were 20% causes DILI including Amoxicillin- clavulanic acid, Azithromycin, Ciprofloxacin,
Erythromycin. Then Antitubercular drugs were 11% responsible for hepatotoxicity. Antimalarial
drugs contribute 11% in DILI includes Falcigo & Artither. HAART & Immunosuppressants
were 6% (each) responsible for hepatotoxicity includes drugs like-zidovudine, Abacavir,
Nevirapine & Methotrexate. Another group of drugs which is 5% (each) responsible for DILI is
Antifungal includes fluconazole & ketocanazole, Lipid lowering agents includes Atorvastatin &
Antihypertensive includes Captopril. Antileprosy drugs were 3% responsible including Dapson.
Some other drugs like anticonvulsant (valproic acid) anticoagulants (Heparin) antacids
(Ranitidine) antidepressants (Olimet/zapiz) & Diuretics (Dytor) were 1% (each) responsible for
hepatotoxicity. [fig. 4]
NSAIDS were 25% causing hepatotoxicity where Nimesulide was found responsible in total
8(11.42%) cases, Diclofenac was present in 6(8.57%) cases, Ibuprofen was present in 2(2.85%)
cases & Naproxen was present in 1(1.42%) case. After that Antibiotic were 20% causes DILI,
where Amoxicillin-clavulanic acid was present in 6(8.57%) cases, Ciprofloxacin was present in
4(5.71%) cases, Azithromycin was present in 2(2.857142857%) cases, Erythromycin was present
in 1 (1.42%) case, and cefixime was present in 1 (1.42%) case. Then Antitubercular drugs were
11% responsible for hepatotoxicity. Antimalarial drugs were responsible in 11% case in DILI
where Falcigo was present in 6(8.57%) cases, and Artither was present in 1 (1.42%) case.
HAART drugs were responsible for hepatotoxicity in 4(5.71%) cases because of its combination
preparation it was very difficult to assess individual drug. Immunosuppressants were also
responsible for 4(5.71%) cases for causing hepatotoxicity includes drugs like- Methotrexate and
Azathioprine. Methotrexate was accounts for 2(2.857142857%) cases, and Azathioprine was
accounts for 2(2.857142857%) cases. Antifungal were 5% responsible for DILI where
fluconazole was present in 2(2.857142857%) cases, & ketocanazole was present in 1 (1.42%)
case. Lipid lowering agents were 5% responsible for DILI includes Atorvastatin &
Antihypertensive were also 5% responsible for DILI includes Captopril. Antileprosy drugs were

3% responsible for DILI including Dapson. Other drugs like anticonvulsant (valproic acid)
anticoagulants (Heparin) antacids (Ranitidine) antidepressants (Olimet/zapiz) & Diuretics
(Dytor) were 1% each responsible for hepatotoxicity. [Table-1]
In total 70 cases we found 164 ADRs, from which in 39.03% ADRs serum bilirubin was elevated
and the mean serum bilirubin was 3.191.95 mg/dl. In 20.73% SGPT/SGOT (AST/ALT) level
were elevated and mean SGPT was 172195 IU, and mean SGOT was 139.418 178.809. In
22.56% hemoglobin level was decreased, mean of Hb was 8.85 2.33 while in 7.31% each
PT/INR & Platelets level was disturbed respectively. Only in 3.04% ADRs Total Leukocyte
Count (TLC) was disturbed. [Table-2]
In over all study according to severity criteria we found mild, moderate and severe type of cases.
In this study out of total 70 cases 49(70%) cases was mild type, in 18(25.7%) cases severity was
moderate but 3(4.3%) cases was severe. In majority of the cases severity was mild, where as
some of them were moderate very few severe cases was also found. [Table-3]
We use WHO causality assessment scale for the causality analysis. By using scale we found 36%
cases were possible ADRs where as 33% cases cause was unlikely. In 20% case was probable
ADRs and 6% cases were unclassified where as remaining 5% cases were unclassifiable. [fig. 5]
Preventability of ADRs was studied using modified Shumock and Thornton criteria. We found
three types, defiantly preventable, probably preventable and not preventable. In Most of the cases
reported ADRs were probably preventable 43(61.42%) where as defiantly preventable were
8(11.42%) and remaining ADRs were not preventable 19(27.14%). [fig. 6]

DISCUSSION:
This was the Prospective observational study conducted at civil and private hospitals of Nasik.
The occurrence of 70 cases of drug induced hepatotoxicity within 2 months short period is
accentuate the seriousness of problem. A specific drug may cause liver damage by many reasons.
First, there are some drugs that are intrinsically toxic to the liver. These drugs can cause liver
injury when the drug is taken in a dosage that exceeds the recommended dosage. This form of
drug hepatotoxicity is known as dose-dependent. Second, there are some drugs that can trigger
an idiosyncratic reaction (an abnormal, unexpected hypersensitivity), to a normal dose of the
drug similar to an allergic reaction, even though a normal dose may be taken. Finally, a persons
susceptibility to a potentially hepatotoxic drug is enhanced by many factors. Some of these
factors are within the persons control, such as cigarette smoking and excessive alcohol intake.
But other factors cannot be altered. These include advancing age and being of the female gender.
We found DILI as well as abnormal LFTs was more common in males than female,
which was in accordance with the study conducted by Sgro et al. in France 13. The expression of
male predominance might be because of more male patients than female in our study. There are
various studies which contradict our findings. The mean age for all patients with abnormal LFTs
& DILI was 40.44 + 4.24 years. This might be because of advancing age, there is decrease
clearance, decrease hepatic blood flow and low hepatic volume all these leads to increase risk of
hepatic injury14.
The liver considered as the most important organ in drug toxicity for two reasons: on one
hand it is functionally interposed between the site of absorption and the systemic circulation and
is a major site of metabolism and elimination of foreign substances; but on the other hand these
features also render it a preferred target for drug toxicity. Drug-induced liver injury therefore
poses a major clinical problem. DILI is commonly classified into intrinsic vs. idiosyncratic
hepatotoxicity; intrinsic hepatotoxicity is regarded as dose dependent and predictable, whereas
idiosyncratic hepatotoxicity occurs without obvious dose-dependency and in an unpredictable
fashion. DILI is divided into three types: hepatocellular, Cholestatic, and mixed according to the
Councils for International Organizations of Medical Sciences (CIOMS).
In this study we have found mainly three types of patterns of liver injury where first one
is Hepatic injury which accounts for 45.7% second one is Cholestatic injury which accounts for
8.6% and last one is mixed type of injury which accounts for 45.7% of DILI. Liver injury is
likely to be more severe in hepatocellular type than in Cholestatic & mixed type and patients
with elevated bilirubin levels in hepatocellular liver injury indicating serious liver injury with
fatalities.
In this study we discussed about drugs suspected of being responsible for cases of DILI.
Although drugs with a well-documented capacity to cause DILI can lead to a different expression
in different patients, most hepatotoxic drugs have signature toxicity. A hepatitic pattern is
typically observed in patients with isoniazid, disulfiram and Diclofenac-associated
hepatotoxicity, whereas Cholestatic injury is seen most often with amoxicillin clavulanic acid
and macrolide antibiotics2. In our study drugs like AKT, Amoxicillin, ciprofloxacin, Diclofenac
were causing hepatic injuries where as HAART, Fluconazole, Azathioprine were responsible for
Cholestatic type of injuries in our population.

A study by Chalasani et al. in USA shows drugs like Antibiotics, CNS agents, Herbs,
Analgesics & Antihypertensive were responsible for DILI 15. Our study shows that following
some drugs are commonly prescribed, which was found responsible for causing drug induced
liver injury. NSAIDS was 25% causing hepatotoxicity which includes drugs like Nimesulide,
Diclofenac, Ibuprofen & Naproxen. After that Antibiotic was 20% causes DILI including
Amoxicillin - clavulanic acid, Azithromycin, Ciprofloxacin, Erythromycin. Then Antitubercular
drugs were 11% responsible for hepatotoxicity. Antimalarial drugs contribute 11% in DILI
includes Falcigo & Artither. HAART & Immunosuppressants was 6% (each) responsible for
hepatotoxicity includes drugs like-zidovudine, Abacavir, Nevirapine & Methotrexate. Another
group of drugs which was 5% (each) responsible for DILI was Antifungal includes fluconazole
& ketocanazole, Lipid lowering agents includes Atorvastatin & Antihypertensive includes
Captopril. Antileprosy drugs are 3% responsible including Dapson. Some other drugs like
anticonvulsant (valproic acid) anticoagulants (Heparin) antacids (Ranitidine) antidepressants
(Olimet/zapiz) & Diuretics (Dytor) was 1% (each) responsible for hepatotoxicity. In a study
conducted by De velle shows Antibiotic, Diclofenac, HIV drugs, Azathioprine, Atorvastatin were
responsible for DILI cases1. Our study result was also in concordance with this study.
In our study we found that AKT drugs were one of the common causes for DILI. Because
of its combination preparation it was difficult to identify individual drug responsible for DILI.
This is in accordance with the study conducted by Kshirsagar et al. where they found
antitubercular drugs as the common cause for drug induced hepatotoxicity7. These findings might
be because of high incidence of tuberculosis in India, especially rural population. This could be
because of low socioeconomic condition and unhygienic environment.
In overall study we found total 164 ADRs from the 70 cases. In most of the cases
abnormal LFTs was found whereas in some cases elevated serum bilirubin level and PT/INR was
present. Apart from this some concomitant ADRs like decrease Hb level & abnormal haematocrit
values were also present in our study. DILI is underreported and neglected in rural areas and it is
an important cause of acute liver failure in adults. In our study we classify severity in three types,
Where 70% cases were mild, 25.7% cases were moderate and only 4.3% cases were the severe.
We have used WHO causality assessment scale for the causality analysis. The WHOUMC system has been developed in consultation with the National Centers participating in the
Programme for International Drug Monitoring and is meant as a practical tool for the assessment
of case reports by using scale we found 20% case was probable ADRs, where as 36% cases was
possible ADRs. In 33% cases cause was unlikely and 6% cases was unclassified where as
remaining 5% cases was unclassifiable.
Preventability of ADRs was studied using modified Shumock and Thornton criteria. Most
of the cases reported ADRs were probably preventable i.e. 61.42% where as definitely
preventable were 11.42% and in remaining cases ADRs were not preventable.
Behind conducting this study our objective was to identify preventable ADRs and
improve public health and safety in relation to use of medicine, but our study was conducted for
short period of time and including few patients. For the better understanding of preventable drug
harms similar studies are needed which covering more patients for longer period of time.

Conclusion:
Hepatotoxicity is the one of the largest problem in community now a day. In many diseases liver
is the target organ which is very important for survival. By medication Doctor helps liver to
recover faster, but in case prescribed drugs causing harm to liver the chances of recovery become
very few. So before prescribing any drug physician have to check all the effects of drug on
human body. After this study we can say there are many commonly prescribed drugs which can
easily cause harm to liver. In this series NSAIDS, some Antibiotics & Antitubercular drugs are
the first rank drugs.

Acknowledgements:
We are immensely thankful to our esteemed guide Dr. Avinash Khairnar, Asst. Professor
University Department of Interpathy Research & Technology MUHS, Nashik for his constructive
criticism, perpetual encouragement, timely advice and meticulous attention were the real driving
forces as well as his keen interest in our project encouraged us a lot. We are very grateful to staff
of civil hospital, Nasik for their cooperation in collecting data of the patients.

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PREVALANCE OF DILI

MALE
34%

FEMALE
66%

FIGURE NO.1: PREVALENCE OF DRUG INDUCED LIVER INJURY

FIGURE NO.2: AGE DISTRIBUTION OF STUDY POPULATION

PATTERN OF DILI
6

Cholestatic
Hepatic

32

Mixed
46%

FIGURE NO.3: PATTERN OF DRUG INDUCED LIVER INJURY

DRUGS CAUSING DILI

18
16
14
12
10
8

Total

6
4
2
0

FIGURE NO.4: DRUGS CAUSING DRUG INDUCED LIVER INJURY

Serial
Drug Class
No.
1
NSAIDs

Antibiotic

3
4

AKT
Antimalarial

5
6

HAART
Immunosuppressant

Antifungal

8
9
10
11
12
13
14
15

Antihypertensive
Lipid lowering agent
Antileprosy
Antacid
Anticoagulant
Anticonvulsion
Antidepressant
Diuretics

Drug Name
Nimesulide
Diclofenac
Ibuprofen
Naproxen
Amoxicillin
Ciprofloxacin
Azithromycin
Erythromycin
Cefixime
Combination
Falcigo
Artisunate
Combination
Methotraxate
Azathioprin
Fluconazole
Ketoconazole
Captopril
Atorvastatin
Dapson
Ranitidine
Heparin
Valproic Acid
Alprazolam
Torsemide

TABLE 1: NO. OF CASES OBSERVED IN HOSPITAL

NO. of cases

Percentage

8
6
2
1
6
4
2
1
1
8
6
1
4
2
2
2
1
3
3
2
1
1
1
1
1

11.42857143
8.571428571
2.857142857
1.428571429
8.571428571
5.714285714
2.857142857
1.428571429
1.428571429
11.42857143
8.571428571
1.428571429
5.714285714
2.857142857
2.857142857
2.857142857
1.428571429
4.285714286
4.285714286
2.857142857
1.428571429
1.428571429
1.428571429
1.428571429
1.428571429

DRUG CLASS

DRUG

No. of
ADRs

LIVER
ENZYME

PT/
INR

S. BILI.

Hb

TLC

Platelets

NSAIDs

ANTIBIOTIC

AKT
ANTIMALARIAL
HAART
IMMUNOSUPPRESAN
T

ANTIFUNGAL

ANTIHYPERTENSIVE
LIPID LOWERING
ANTILEPROSY
ANTACID
ANTICOAGULANT
ANTICONVULSION
ANTIDEPRESSANT
DIURETIC
TOTAL

Nimesulide
Diclofenac
Ibuprofen
Naproxen
Amoxy-Clav
Ciprofloxaci
n
Azithromyci
n
Erythromyci
n
Cefixime
AKT
Falcigo
Artisunate
HAART
Methotrexat
e
Azathioprin
e
Fluconazole
Ketocanazol
e
Captopril
Atorvastatin
Dapsone
Ranitidine
Heparin
Valproic
Acid
Alprazolam
Torsemide

19
8
4
2
16

6
0
0
0
5

0
2
0
0
0
0

8
4
2
1
6
4

5
2
2
1
3
2

0
0
0
0
0
0

0
0
0
0
2
0

0
1
2
1
0
0

1
8
5
0
4
2

1
3
1
0
3
1

0
0
3
0
0
0

0
0
4
1
1
0

0
0

2
1

2
0

1
0

0
0

1
1
0
0
1
0

3
3
2
1
0
1

2
1
2
1
0
1

1
0
0
0
0
0

0
2
0
0
0
0

1
1
12

0
1
64

0
1
37

0
0
5

0
1
12

1
3
17
20
2
9

0
1
5
5
0
1

5
6

1
1

1
7
9
4
3
1

0
0
2
0
1
0

3
1
5
164

1
0
1
34

TABLE 2: NO. OF ADRS PER DRUG OBSERVED IN HEPATOBILIARY PATIENTS:

Intensity
Mild
Moderate
Severe
Total

Frequency
49
18
3
70

Percent
70.0
25.7
4.3
100.0

Cumulative Percent
70.0
95.7
100.0

TABLE 3: SHOWING SEVERITY OF DRUG INDUCED LIVER INJURY

CAUSALITY ASSESSMENT
30
25

25

24

20

Frequency

14

15
10

Unclassifiable

Unclassified

5
0
Possible

Probable

Unlikely

FIGURE NO 5: CAUSALITY ASSESSMENT USING WHO SCALE

PREVENTABILITY OF ADRs
Not Preventable

19

Probably Preventable

Number of cases

43

Defiantly Preventable

10

15

20

25

30

35

40

45

50

FIGURE NO 6: PREVENTABILITY OF ADRs