OUTCOME OF CAUSALITY ASSESSMENTS FOR SUSPECTED CASES OF ADVERSE DRUG REACTIONS IN 2022

The Pharmacy Board of Sierra Leone National Pharmacovigilance Centre in October 2020 conducted three sets of causality assessments for pharmaceutical products for which Adverse Drug Reaction reports were receive. The causality assessment sessions were held on the 21^st 24th and 25^th October 2022. Please find below a summary of the Outcome of the Causality Assessment. 

Note: For all products the Summary of Product Characteristics as per the Manufacturer's release and in the specific product  and the Naranjo Scale were employed. 

1.       METAMIZOLE 500MG IV:

    Adverse Drug Reaction Reported: Generalised Body Rash 

Any concomitant therapy: Levofloxacin was administered 

Causality Assessment : Probable causal relationship 

Outcome of the Causality Assessmen/Risk Minimzation:    Caution should be taken and monitoring should be robust when metamizole and

       given concurrently with levofloxacin. Drug hypersensitivity tests should also be

       considered when administering drugs that can result in hypersensitivity

       reactions.

2.       CIPROFLOXACIN 400MG IV

Adverse Drug Reaction Reported : Seizure

Any concomitant drug administered: Not indicated 

Causality Assessment : Probable 

Outcome of the Causality Assessment/Risk Minimization:Drug hypersensitivity tests should also be

       considered when administering drugs that can result in hypersensitivity

       reactions.

3.       MEBFIL (MEBENDAZOLE 100MG)

Adverse Drug Reaction Reported : Watery and bloody stool and death

Any concomitant therapy: Not indicated 

Causality Assessment : Possible 

Outcome of the Causality Assessment/Risk Minimization: For best practice stool test is very important to determine the types of worms and their corresponding antihelminthes (e.g.Mebfil).

4.       HALOPERIDOL 10MG TABLET

Adverse Drug Reaction Reported :   Weakness and unsteady gait

Any concomitant therapy: Not indicated 

Causality Assessment : Possible 

Outcome of the Causality Assessment/ Risk Minimization: Other pharmacologic and non-pharmacologic interventions that can beneficial in addition to the use of antimuscarinic (Trihexyphenidyl) are substituting with another atypical antipsychotic depending on the availability.  Dose reduction may lead to the relief of symptoms except for tardive dyskinesia which cannot be predicted.

5.       FLUPHENAZINE 25MG TABLET 

Adverse Drug Reaction Reported : Tiredness and dizziness 

Any concomitant therapy: Not indicated 

Causality Assessment :  Possible 

Outcome of the Causality Assessment: Caution should be taken when Fluphenazine is mainly used concurrently with

       other medicines as this combination may increase the risk of

        profound CNS and respiratory depression through their additive drug-drug

       interaction. Therefore you can use an alternative or monitor respiratory rate

       BP; consider decreasing the dose of one or both drugs and use the lowest

      effective doses and shortest duration.

6.       CARBAMAZEPINE 200 TABLET 

    Adverse Drug Reaction Reported:  Weakness

   Any concomitant Therapy: Not indicated 

Causality Assessment Rating: Possible

Outcome of the Causality Assessment/Risk Minimization: Caution should be taken when Carbamazepine is mainly used concurrently with

       other medicines especially in psychiatry settings as this combination may

       increase the risk of profound CNS and respiratory depression through their

       additive drug-drug interaction. Therefore you can use an alternative or monitor

       respiratory rate BP; consider decreasing the dose of one or both drugs and use

       the lowest effective doses and shortest duration. 

7.       COTRIMOXAZOLE 480MG

Adverse Reaction Reported : Steven Johnson reaction

Any concomitant Therapy: Not indicated 

Any concomitant disease condition: Not indicated 

Causality Assessment Rating : Probable

Outcome of the Causality Assessment /Risk Minimization: Drug Hypersensitivity to sulfa drugs should be done before administration

8.        BUSCOPAN IV 10MG ( HYSOSCINE BUTYLYBROMIDE)

Adverse Drug Reaction Reported : Profuse sweating restlessness and jerky movement

Any concomitant Therapy: Not indicated 

Any concomitant disease condition: Not indicated 

Causality Rating : Possible 

Causality Assessment Outcome/Risk Minimization: Because of the possibility that anticholinergics may reduce sweating buscopan should be administered with caution in those with pyrexia continuous monitoring of patients are also advised as they can cause hypotension and tachycardia

9.       CEFTRIAXONE 1G INJECTION

Adverse Drug Reaction Reported:  Swollen lips and urticaria  

Any concomitant Therapy: Not indicated 

Any concomitant disease condition: Not indicated 

Causality Rating : Possible 

 Causality Assessment Outcome/Risk Minimization:  Ceftriaxone should be given with caution to patients with a history of hypersensitivity reaction to  the drug or any penicillin or any other beta lactam drug. Continued monitoring should be instituted when the drug is given      

10.    SODIUM VALPROATE 200MG

Adverse Drug Reaction Reported:   Weakness and body stiffness

Any concomitant Therapy: Not indicated 

Any concomitant disease condition: Not indicated 

Causality Rating : Possible 

 Causality Assessment Outcome/Risk Minimization: Patients taking Sodium valproate should be regularly checked by doctors because of its tendency to cause reactions that can affect multiple body organs. Discontinuation of the drug should be done under supervision

11.   LISINOPRIL 5mg

Adverse Drug Reaction Reported: Restlessness and weakness 

Any concomitant Therapy: Not indicated 

Any concomitant disease condition: Not indicated 

Causality Rating : Possible 

 Causality Assessment Outcome/Risk Minimization:  Continuous monitoring of patient should be paramount after administration.  Continued dosage reduction should also be continued

 12.    PARACETAMOL 500mg

Adverse Drug Reaction Reported: Itching rash

Any concomitant Therapy: Not indicated 

Any concomitant disease condition: Not indicated 

Causality Rating : Possible 

 Causality Assessment Outcome/Risk Minimization:  Monitoring of patients after taking paracetamol is of importance.

ü  Alternative analgesics can be provided for the patient.

13.   METOCLOPRAMIDE 10mg

Adverse Drug Reaction Reported: Restlessness and unconsciousness

Any concomitant Therapy: Not indicated 

Any concomitant disease condition: Not indicated 

Causality Rating : Possible 

 Causality Assessment Outcome/Risk Minimization:  It should be used with caution in patients with hypertension since there is limited evidence that the drug may increase circulating catecholamines in such patients.

ü  The time interval should be respected between each metoclopramide administration even in case of vomiting and rejection of the dose in order to avoid overdose.

For further information please contact the National Pharmacovigilance Centre hosted by the Pharmacy Board of Sierra Leone and/or the Information and Communication Department of the Board through the following email addresses;

- otabiri@pharmacyboard.gov.sl

- info@pharmacyboard.gov.sl

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