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DRUG TOXICITY &
            ADVERSE DRUG
             REACTIONS
UNDER THE               PRESENTED BY:
GUIDANCE OF:            ANSH DEV RAVI
Dr. Amrish Chandra      A4513309001
 ADVERSE DRUG REACTION/ADE/DRUG TOXICITY can be "an
  appreciably harmful or unpleasant reaction, resulting from an
  intervention related to the use of a medicinal product, which
  predicts hazard from future administration and warrants prevention
  or specific treatment, or alteration of the dosage regimen, or
  withdrawal of the product.“

 Adverse drug reactions are classified into six types:
  Dose-related (Augmented)
  Non-dose-related (Bizarre)
   Dose-related and time-related (chronic)
  Time-related (delayed)
   Withdrawal (end of use)
  Failure of therapy (failure)                                        2
DRUG TOXICITY/ADR/ADE is defined as "manifestations of
the adverse effects of drugs administered therapeutically or
in the course of diagnostic techniques. It does not include
accidental or intentional poisoning...“

It may result when :
  the dose is too high
  the liver or kidneys are unable
    to remove the drug from the
    bloodstream

                                                               3
GIVEN BY WHO
• Noxious and unintended response to medicinal product if a
  medicine is properly prescribed and administered.
• Casual reaction between medicinal product and adverse event
  cannot be ruled out.
• Medical errors are not included in this definition.
GIVEN BY MHRA
• an unwanted or harmful reaction experienced following
  the administration of a drug or drugs.
• suspected to be related to the drug or drugs.
• The reaction may be a known side-effect of the drug or it may be
  new and previously unrecognised.

                                                                     4
5
TYPE A REACTIONS                  TYPE B REACTIONS
CHARACTERISTICS
1. Predictable                    1. Unpredictable
2. Usually dose dependent         2. Rarely dose dependent
3. High morbidity                 3. Low morbidity
4. Low mortality                  4. High mortality
5. Responds to drug reactions     5. Responds to drug withdrawal
6. Identified pre -marketing      6. Identified post- marketing
EXAMPLES
Sulphonylureas- hypoglycaemia     Penicillins- anaphylaxis
Phenothiazines- orthostatic
                                  Chloramphenicol- aplastic anaemia
hypotension
                                  Carbamazepine- Stevens- Johnson
Stilboestrol- vaginal carcinoma
                                  syndrome                            6
 TYPE C :
   Dose-related and time-related
   Related to duration and dosage of exposure.
    Example: hypothalamic-pituitary-adrenal suppression from
    glucocorticoid therapy.
 TYPE D :
   Time-related
   Delayed reaction
    Example: tardive dyskinesia.



                                                           7
 Type E:
    Withdrawal
    Lend of dose reaction
     Example: narcotic or beta-blocker withdrawal
 Type F:
    Unexpected failure of therapy
    May be caused by drug interactions
      Example: failure of oral contraceptives due to induction
     of enzymes by a second drug.



                                                                 8
 Drug reaction with eosinophilia and systemic symptoms may
  be caused by medications including:
   Allopurinol
   Phenytoin
   Dapsone
   Carbamazepine
   Trimethoprim-sulfamethoxazole
   Penicillin
   Non-steroidal anti-inflammatory agents



                                                          9
 Defined as the phenomenon that occurs
  when the effect of pharmacokinetics of
  the drugs are altered by prior
  administration or co administration of
  second drug.

 A particularly important type of adverse
  drug event
 Complex, involving either increasing or
  decreasing the activity of a given
  cytochrome pathway, or preferentially
  using the pathway rather than other drugs.
                                               10
• Monoamine oxidase inhibitors can cause fatal hypertension in
  patients who have also consumed food containing high
  concentrations of tyramine.
• The suspect foods form an odd assortment
   EXAMPLE: Chianti wine, some smoked fish and aged cheese




                                                             11
 BY FREQUENCY
  The recommendations of WHO have been summarized by:
    very common (1/10 patients)
    common (1/100)
    uncommon (1/1000)
    rare (1/10,000)
    very rare (1/100,000)
 BY SEVERITY
  The American Food and Drug Administration defines severe
  effects as:
   Death
   Life-Threatening
                                                             12
 Hospitalization (initial or prolonged)
 Disability - significant, persistent, or permanent change,
  impairment, damage or disruption in the patient's body
  function/structure, physical activities or quality of life.

 Requires Intervention to Prevent Permanent Impairment
  or Damage




                                                                13
 As research better explains the biochemistry of drug use, less
  ADRs are Type B and more are Type A
 Risk factors are:
    The number of drugs
    History of prior drug toxicity
    Presence of heart failure
    Presence of liver disease
    Presence of renal failure
    Presence of 4 or more medical conditions



                                                               14
Common Mechanisms……
1. ABNORMAL PHARMACOKINETICS due to
 – Comorbid disease states:
     Various diseases, especially those that cause renal or
     hepatic insufficiency, may alter drug metabolism.
 – Genetic factors:
     Abnormal drug metabolism may be due to inherited factors
     of either Phase I oxidation or Phase II conjugation.
2. SYNERGISTIC EFFECTS between either
    – a drug and a disease
    – two drugs

                                                            15
FACTORS INCREASING
ADR’s
1. POLYPHARMACY
― The risk of drug interactions may be increased.
― Using 11 or more chronic medications is a risk factor for
   drug toxicity
2. FRAGMENTED HEALTH CARE
   When controlled for other factors such as the number of
   prescribing physicians, the number of medications may
   not be a risk factor for adverse drug reactions.


                                                          16
ASSESSING CAUSALITY
    A scale proposed by the World Health Organization (WHO) is
    below:
a. Certain                       d. Unlikely
b. Probable/likely               e. Conditional/ unclassified
c. Possible                       f. Unassessable/ unclassifiable
4. INTOLERANCE TO MULTIPLE DRUGS
― Amplification may contribute to multiple-drug intolerance.
― This is distinct from multiple drug hypersensitivity.



                                                                    17
SYPMTOMS OF DRUG
TOXICITY
1.SYMPTOMS OF GHB:
 i. PALPITATION
 ii. COMA
 iii. HYPOTENSION
 iv. HYPOTHERMIA
 v. MUSCLE CRAMPS
 vi. NAUSEA AND VOMITING
 vii. SLOW BREATHING
 viii. VOILENT BEHAVIOR


                           18
2. SYMPTOMS OF HALLUCINOGEN
 i.      ANXIETY
 ii.     DELUSION
 iii.    DEPRESSION
 iv.     HALUCINATIONS
 v.      PANIC ATTACK
 vi.     PARANOIA
 vii.    RESTLESSNESS
 viii.   VIOLENT BEHAVIOR
 ix.     SEIZURES



                              19
List of drugs that have been identified as
those with the highest potential for harm:

•   Warfarin
•   Aspirin
•   Metformin
•   Insulin
•   Glyburide
•   Digoxinvalproic Acid




                                             20
To Avoid Drug Toxicity
• Keep a careful record of what drugs you are taking including over
   the counter drugs.

• Inform all doctors you see of every medication you are taking and be
   aware of what the dosage is. Also list supplements, herbs or other
   OTC medicine you are taking.

• If blood tests do not bring your doctor to a diagnosis, ask him to do a
   specific test for drug toxicity.

• Eliminate or reduce the dose of a suspected medication under
   doctors care.

                                                                       21
REFERENCES
•   Essentials of Medical Pharmacology (6th edition) by KD Tripathi
•   Drug Toxicity Encyclopedia Article- Citizendium
•   thepharmacist.co.uk
•   pubmedresult.com
•   wikipedia




                                                                      22
23

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Term paper presentation 3- Adverse Drug Reactions & Drug Toxicity

  • 1. DRUG TOXICITY & ADVERSE DRUG REACTIONS UNDER THE PRESENTED BY: GUIDANCE OF: ANSH DEV RAVI Dr. Amrish Chandra A4513309001
  • 2.  ADVERSE DRUG REACTION/ADE/DRUG TOXICITY can be "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.“  Adverse drug reactions are classified into six types: Dose-related (Augmented) Non-dose-related (Bizarre)  Dose-related and time-related (chronic) Time-related (delayed)  Withdrawal (end of use) Failure of therapy (failure) 2
  • 3. DRUG TOXICITY/ADR/ADE is defined as "manifestations of the adverse effects of drugs administered therapeutically or in the course of diagnostic techniques. It does not include accidental or intentional poisoning...“ It may result when : the dose is too high the liver or kidneys are unable to remove the drug from the bloodstream 3
  • 4. GIVEN BY WHO • Noxious and unintended response to medicinal product if a medicine is properly prescribed and administered. • Casual reaction between medicinal product and adverse event cannot be ruled out. • Medical errors are not included in this definition. GIVEN BY MHRA • an unwanted or harmful reaction experienced following the administration of a drug or drugs. • suspected to be related to the drug or drugs. • The reaction may be a known side-effect of the drug or it may be new and previously unrecognised. 4
  • 5. 5
  • 6. TYPE A REACTIONS TYPE B REACTIONS CHARACTERISTICS 1. Predictable 1. Unpredictable 2. Usually dose dependent 2. Rarely dose dependent 3. High morbidity 3. Low morbidity 4. Low mortality 4. High mortality 5. Responds to drug reactions 5. Responds to drug withdrawal 6. Identified pre -marketing 6. Identified post- marketing EXAMPLES Sulphonylureas- hypoglycaemia Penicillins- anaphylaxis Phenothiazines- orthostatic Chloramphenicol- aplastic anaemia hypotension Carbamazepine- Stevens- Johnson Stilboestrol- vaginal carcinoma syndrome 6
  • 7.  TYPE C :  Dose-related and time-related  Related to duration and dosage of exposure. Example: hypothalamic-pituitary-adrenal suppression from glucocorticoid therapy.  TYPE D :  Time-related  Delayed reaction Example: tardive dyskinesia. 7
  • 8.  Type E:  Withdrawal  Lend of dose reaction Example: narcotic or beta-blocker withdrawal  Type F:  Unexpected failure of therapy  May be caused by drug interactions Example: failure of oral contraceptives due to induction of enzymes by a second drug. 8
  • 9.  Drug reaction with eosinophilia and systemic symptoms may be caused by medications including:  Allopurinol  Phenytoin  Dapsone  Carbamazepine  Trimethoprim-sulfamethoxazole  Penicillin  Non-steroidal anti-inflammatory agents 9
  • 10.  Defined as the phenomenon that occurs when the effect of pharmacokinetics of the drugs are altered by prior administration or co administration of second drug.  A particularly important type of adverse drug event  Complex, involving either increasing or decreasing the activity of a given cytochrome pathway, or preferentially using the pathway rather than other drugs. 10
  • 11. • Monoamine oxidase inhibitors can cause fatal hypertension in patients who have also consumed food containing high concentrations of tyramine. • The suspect foods form an odd assortment EXAMPLE: Chianti wine, some smoked fish and aged cheese 11
  • 12.  BY FREQUENCY The recommendations of WHO have been summarized by:  very common (1/10 patients)  common (1/100)  uncommon (1/1000)  rare (1/10,000)  very rare (1/100,000)  BY SEVERITY The American Food and Drug Administration defines severe effects as:  Death  Life-Threatening 12
  • 13.  Hospitalization (initial or prolonged)  Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.  Requires Intervention to Prevent Permanent Impairment or Damage 13
  • 14.  As research better explains the biochemistry of drug use, less ADRs are Type B and more are Type A  Risk factors are:  The number of drugs  History of prior drug toxicity  Presence of heart failure  Presence of liver disease  Presence of renal failure  Presence of 4 or more medical conditions 14
  • 15. Common Mechanisms…… 1. ABNORMAL PHARMACOKINETICS due to – Comorbid disease states: Various diseases, especially those that cause renal or hepatic insufficiency, may alter drug metabolism. – Genetic factors: Abnormal drug metabolism may be due to inherited factors of either Phase I oxidation or Phase II conjugation. 2. SYNERGISTIC EFFECTS between either – a drug and a disease – two drugs 15
  • 16. FACTORS INCREASING ADR’s 1. POLYPHARMACY ― The risk of drug interactions may be increased. ― Using 11 or more chronic medications is a risk factor for drug toxicity 2. FRAGMENTED HEALTH CARE When controlled for other factors such as the number of prescribing physicians, the number of medications may not be a risk factor for adverse drug reactions. 16
  • 17. ASSESSING CAUSALITY A scale proposed by the World Health Organization (WHO) is below: a. Certain d. Unlikely b. Probable/likely e. Conditional/ unclassified c. Possible f. Unassessable/ unclassifiable 4. INTOLERANCE TO MULTIPLE DRUGS ― Amplification may contribute to multiple-drug intolerance. ― This is distinct from multiple drug hypersensitivity. 17
  • 18. SYPMTOMS OF DRUG TOXICITY 1.SYMPTOMS OF GHB: i. PALPITATION ii. COMA iii. HYPOTENSION iv. HYPOTHERMIA v. MUSCLE CRAMPS vi. NAUSEA AND VOMITING vii. SLOW BREATHING viii. VOILENT BEHAVIOR 18
  • 19. 2. SYMPTOMS OF HALLUCINOGEN i. ANXIETY ii. DELUSION iii. DEPRESSION iv. HALUCINATIONS v. PANIC ATTACK vi. PARANOIA vii. RESTLESSNESS viii. VIOLENT BEHAVIOR ix. SEIZURES 19
  • 20. List of drugs that have been identified as those with the highest potential for harm: • Warfarin • Aspirin • Metformin • Insulin • Glyburide • Digoxinvalproic Acid 20
  • 21. To Avoid Drug Toxicity • Keep a careful record of what drugs you are taking including over the counter drugs. • Inform all doctors you see of every medication you are taking and be aware of what the dosage is. Also list supplements, herbs or other OTC medicine you are taking. • If blood tests do not bring your doctor to a diagnosis, ask him to do a specific test for drug toxicity. • Eliminate or reduce the dose of a suspected medication under doctors care. 21
  • 22. REFERENCES • Essentials of Medical Pharmacology (6th edition) by KD Tripathi • Drug Toxicity Encyclopedia Article- Citizendium • thepharmacist.co.uk • pubmedresult.com • wikipedia 22
  • 23. 23