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PHARMACOVIGILANCE
CASE
PRESENTATION
Dr. Pranesh Pawaskar
First Year Resident
Dept. of Pharmacology
L.T.M.M.C. Sion, Mumbai...
Prednisolone induced
vaso - occlusive crisis
2
case
• Male
• 12 Years
• K/C/O Sickle Cell Anaemia + Thalassaemia Major.
• Chief Complaints – 4 Episodes Of Convulsion
- S...
Course of reaction
Patient is a k/c/o sickle cell anaemia +
thalassemia major since childhood
(family history +ve)
.
.
Req...
Course of reaction
On 4/12/16
Admitted to Sion hospital
Under Dr.MVM in Ward 37
.
.
Patient has chronic bone pain but was ...
Course of reaction
Treatment at Sion Hospital –
• i.v. fluids. (N.S. with 5% Dextrose).
• Cap. Hydroxyurea 400 mg.
• Inj. ...
Investigations
• MRI lower limbs –
• s/o Ischaemic changes Left > right.
• MRI Brain –
• S/o Normal vasculature.
7
Seriousness of reaction
• Reaction was SERIOUS as it Required
Hospitalisation of patient.
• Patient Recovered And Discharg...
9
1
2
1
0
-
1
0
0
1
0
1
4
Causality assessment
• According to Naranjo Scale score is 4
POSSIBLE
BECAUSE -
1) Reasonable time-event relationship.
2) ...
VASO – OCCLUSIVE CRISIS
• The Vaso-occlusive Crisis is caused by sickle-
shaped red blood cells that obstruct capillaries
...
SICKLE CELL DISEASE
• Inherited blood disorder.
• Inheritation of 2
abnormal copies of Hb
gene one from each
parent.
• Cau...
SICKLE CELL DISEASE
• It results in an abnormal
haemoglobin found in red
blood cells.
• This leads to a rigid,
sickle-like...
SICKLE CELL DISEASE
• A number of health problems may develop, such
as attacks of pain ("Sickle-cell Crisis"),
Anaemia, Ba...
CAUSES OF VASO-OCCLUSIVE CRISIS
• Infections
• Severe dehydration
• Exposure to very high or very low temperatures,
or rap...
PREDNISOLONE
• Prednisolone is a Steroid Medication used to
treat certain types of Allergies, Inflammatory
Conditions, Aut...
PHARMACOLOGY
• Absorption duration – 18 -36 hr
• Protein bound 65-91 %
• Vd = 0.22 – 0.7 L/kg
• Extensively metabolised in...
USES
ADULT
• Rheumatoid Arthritis
• Multiple Sclerosis
• Acute Exacerbation of
COPD
• Bells Palsy
PAEDIATRIC
• Inflammatio...
ADVERSE EFFECTS
• Acne
• Adrenal Suppression
• Diabetes Mellitus
• Menstrual Irregularity
• Myopathy
• Neuritis
• Peptic u...
INTERACTIONS
• Mifepristone
• Live Vaccines
• Ketoconazole, Cimetidine
• Erythromycin, Carbamazepine, Rifampin
• Aceclofen...
MECHANISMBEHINDVASO-OCCLUSIVE CRISIS
• The potential mechanism(s) involved in systemic
steroid-induced vaso-occlusion is u...
Mechanism BehindVaso-occlusive Crisis
• Additionally, we speculate that Steroid-induced
Leucocytosis could be another pote...
MECHANISMBEHINDVASO-OCCLUSIVE CRISIS
1. A patient with Hemoglobin-S/C Disease who
developed fatal sickle cell crisis after...
Management of vaso-occlusive crisis
• For Milder Crisis, manage on Nonsteroidal Anti-
inflammatory Drugs (Diclofenac or Na...
MANAGEMENT OF VASO-OCCLUSIVE CRISIS
• Painful Crises are treated with Hydration,
Analgesics, & Blood Transfusion; Pain man...
MANAGEMENT OF VASO-OCCLUSIVE CRISIS
• Many crises can be managed at home with oral
hydration and oral analgesia.
• Most cr...
MANAGEMENT OF VASO-OCCLUSIVE CRISIS
• Hydroxyurea (10–30 mg/kg per day) increases fetal
haemoglobin.
• Exert beneficial af...
CONCLUSION
• The present case emphasizes the poor tolerance
of steroids in SCD patients
• Review of literature suggest tha...
CONCLUSION
• Prompt Red-cell Transfusion or Exchange
Transfusion along with aggressive clinical
management can improve the...
30
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Prednisone induced vaso occlusion

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adverse drug reaction to prednisolone a pharmacovigilance case

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Prednisone induced vaso occlusion

  1. 1. PHARMACOVIGILANCE CASE PRESENTATION Dr. Pranesh Pawaskar First Year Resident Dept. of Pharmacology L.T.M.M.C. Sion, Mumbai 400022 Date : 06/01/2017 1
  2. 2. Prednisolone induced vaso - occlusive crisis 2
  3. 3. case • Male • 12 Years • K/C/O Sickle Cell Anaemia + Thalassaemia Major. • Chief Complaints – 4 Episodes Of Convulsion - Severe Pain In Lower Limbs & - Altered Consciousness - 3
  4. 4. Course of reaction Patient is a k/c/o sickle cell anaemia + thalassemia major since childhood (family history +ve) . . Requires periodic blood transfusion . . Patient got admitted with • Excruciating pain in lower limbs (L>R) (since 2/12/16), • 4 episodes of Convulsions (4/12/16), • Altered Consciousness 4
  5. 5. Course of reaction On 4/12/16 Admitted to Sion hospital Under Dr.MVM in Ward 37 . . Patient has chronic bone pain but was exaggerated since one month On 6/11/16 For which he was started with T. Prednisolone @ 2 mg/kg/day Pt was continuously taking T. Prednisolone 60 mg in two divided doses daily ( tapered to 30mg/kg on 4/12/16, 15mg/kg on 12/12/16 and 10mg/kg on 19/12/16 ) 5
  6. 6. Course of reaction Treatment at Sion Hospital – • i.v. fluids. (N.S. with 5% Dextrose). • Cap. Hydroxyurea 400 mg. • Inj. Paracetamol 500 mg SOS. • Inj. Pantoprazole 40mg O.D. • Inj. Ondansetron 8 mg B.D. 6
  7. 7. Investigations • MRI lower limbs – • s/o Ischaemic changes Left > right. • MRI Brain – • S/o Normal vasculature. 7
  8. 8. Seriousness of reaction • Reaction was SERIOUS as it Required Hospitalisation of patient. • Patient Recovered And Discharged on 20/12/16 • Diagnosis- Steroid Induced Vaso-occlusive Crisis. 8
  9. 9. 9 1 2 1 0 - 1 0 0 1 0 1 4
  10. 10. Causality assessment • According to Naranjo Scale score is 4 POSSIBLE BECAUSE - 1) Reasonable time-event relationship. 2) De-challenge response positive. POSSIBLE 10
  11. 11. VASO – OCCLUSIVE CRISIS • The Vaso-occlusive Crisis is caused by sickle- shaped red blood cells that obstruct capillaries and restrict blood flow to an organ. • Resulting in Ischaemia, Pain, Necrosis, and often Organ Damage. 11
  12. 12. SICKLE CELL DISEASE • Inherited blood disorder. • Inheritation of 2 abnormal copies of Hb gene one from each parent. • Caused by a mutation in the beta-globin gene that changes the sixth amino acid from glutamic acid to valine. 12
  13. 13. SICKLE CELL DISEASE • It results in an abnormal haemoglobin found in red blood cells. • This leads to a rigid, sickle-like shape under certain circumstances. • Problems in sickle cell disease typically begin around 5 to 6 months of age. 13
  14. 14. SICKLE CELL DISEASE • A number of health problems may develop, such as attacks of pain ("Sickle-cell Crisis"), Anaemia, Bacterial Infections, And Stroke. • Long term pain may develop as people get older. 14
  15. 15. CAUSES OF VASO-OCCLUSIVE CRISIS • Infections • Severe dehydration • Exposure to very high or very low temperatures, or rapid change in temperature. • High altitudes, where oxygen levels are low • Drugs 15
  16. 16. PREDNISOLONE • Prednisolone is a Steroid Medication used to treat certain types of Allergies, Inflammatory Conditions, Autoimmune Disorders • Some of these conditions include Adrenocortical Insufficiency, High Blood Calcium, Rheumatoid Arthritis, Dermatitis, Eye Inflammation, Asthma, And Multiple Sclerosis • It is use by oral,intravenous injection, as a skin cream, and as eye drops. 16
  17. 17. PHARMACOLOGY • Absorption duration – 18 -36 hr • Protein bound 65-91 % • Vd = 0.22 – 0.7 L/kg • Extensively metabolised in liver • Half – Life = 3 hr • Excretion = Urine 17
  18. 18. USES ADULT • Rheumatoid Arthritis • Multiple Sclerosis • Acute Exacerbation of COPD • Bells Palsy PAEDIATRIC • Inflammation • Acute Asthmatic Exacerbation • Nephrotic Syndrome 18
  19. 19. ADVERSE EFFECTS • Acne • Adrenal Suppression • Diabetes Mellitus • Menstrual Irregularity • Myopathy • Neuritis • Peptic ulcer • Osteoporosis • Psychosis • Weight Gain • Seizures • Vertigo 19
  20. 20. INTERACTIONS • Mifepristone • Live Vaccines • Ketoconazole, Cimetidine • Erythromycin, Carbamazepine, Rifampin • Aceclofenac, Aspirin, Ibuprofen • Heparin, Liraglutide • Serolimus, Tacrolimus 20
  21. 21. MECHANISMBEHINDVASO-OCCLUSIVE CRISIS • The potential mechanism(s) involved in systemic steroid-induced vaso-occlusion is unclear. • Bone marrow infarction and likely associated Fat Embolism may have contributed to the adverse events. • There is a well-documented association of corticosteroid therapy and Bone Marrow Necrosis. 21
  22. 22. Mechanism BehindVaso-occlusive Crisis • Additionally, we speculate that Steroid-induced Leucocytosis could be another potential factor. • High WBC counts in steady state have been linked to worse clinical course, and Polymorphonuclear Leukocytes appear to play an active role in vaso -occlusive crises. • Granulocytes or Stimulating Agents have been associated with the apparent triggering of sickle-related crises and multiorgan failure in isolated case reports. 22
  23. 23. MECHANISMBEHINDVASO-OCCLUSIVE CRISIS 1. A patient with Hemoglobin-S/C Disease who developed fatal sickle cell crisis after receiving Granulocyte Colony Stimulating Factor was also on daily Dexamethasone. 2. Severe complications were observed in ten of the 16 patients (62%). Eight patients experienced severe vaso-occlusive events (VOE) within the 2 months following the initiation of steroid treatment. Frequency of painful crises (2X),severe pain episode, Acute Chest Syndrome, stroke,& Renal infarction. 23
  24. 24. Management of vaso-occlusive crisis • For Milder Crisis, manage on Nonsteroidal Anti- inflammatory Drugs (Diclofenac or Naproxen.) • For more Severe Crises, most patients require inpatient management for Intravenous Opioids; Patient-controlled Analgesia Devices are commonly used in this setting. • Vaso-occlusive crisis involving organs such as the Penis or Lungs are considered an emergency and treated with Red-blood Cell Transfusions. 24
  25. 25. MANAGEMENT OF VASO-OCCLUSIVE CRISIS • Painful Crises are treated with Hydration, Analgesics, & Blood Transfusion; Pain management requires Opioid Administration at regular intervals. • Vigorous hydration. • Bone pain may respond as well to Ketorolac (30– 60 mg initial dose, then 15–30 mg every 6–8 h). • Morphine (0.1–0.15 mg/kg every 3–4 h) should be used to control severe pain 25
  26. 26. MANAGEMENT OF VASO-OCCLUSIVE CRISIS • Many crises can be managed at home with oral hydration and oral analgesia. • Most crises resolve in 1–7 days. • Use of blood transfusion should be reserved for extreme cases, transfusions do not shorten the duration of the crisis. • The most significant advance in the therapy of sickle cell anaemia has been the introduction of Hydroxyurea as a mainstay of therapy for patients with severe symptoms. 26
  27. 27. MANAGEMENT OF VASO-OCCLUSIVE CRISIS • Hydroxyurea (10–30 mg/kg per day) increases fetal haemoglobin. • Exert beneficial affects on RBC Hydration, Vascular Wall Adherence, and Suppression of the granulocyte and Reticulocyte count. • Maintain a white cell count between 5000 and 8000/L. • White Cells And Reticulocytes may play a major role in the pathogenesis of sickle cell crises, their suppression may be an important benefit of hydroxyurea therapy. 27
  28. 28. CONCLUSION • The present case emphasizes the poor tolerance of steroids in SCD patients • Review of literature suggest that systemic corticosteroids play an important role in the development of severe adverse events in some patients with SCD. • With better understanding of risk factors, prevalence and pathophysiology of these events, systemic corticosteroids should be used with caution in this population. 28
  29. 29. CONCLUSION • Prompt Red-cell Transfusion or Exchange Transfusion along with aggressive clinical management can improve the clinical outcome in severe cases. • Red blood cell transfusions given with corticosteroid therapy in SCD patients may attenuate the risk of such complications. 29
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