Adverse Drug Reactions (ADRs)

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6. Teratogenicity

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 Glucose-6-phosphate
dehydrogenase (G-6-PD)
Glucose-6-phosphate 6-Phosphogluconate + H2

NADP NADPH

* NADPH keeps glutathione in reduced form

* Certain drugs like anti-malarials or anti-pyretics can oxidise glutathione

Denatured
Haemoglobin Haemoglobin
In presence of oxidised
glutathione (formed due to
absense of NADPH or G-6-PD)

Haemolytic Decrease Desroyed Erythrocyte

Anaemia in RBC in Speen shirinkage

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6. Teratogenicity

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 Yellow Card
Suspected Adverse Event Reporting Form
Identities of reporter, patient, institution, and product trade name(s) will remain confidential

A. FOR OFFICE USE ONLY

AE report number Date received
B. PATIENT INFORMATION

Name/Initial : *Age----- Weight(Kg)------*Gender Male Female Other

Address :
*Contact number : Pregnant : Yes No Unknown Not applicable
C. SUSPECTED ADVERSE EVENT INFORMATION
*Type of event Suspected product
Adverse drug reaction
Brand/Trade name *Generic name with strength
Product quality problem
*Indication
Medication error
*Medication Start Date End Date
Others(Please specify) Dosage Form *Frequency (Daily Dose)
Batch/Lot number Manufacturer

*Describe event including relevant tests and laboratory results:

Was the adverse event treated? Yes No

*Event start Date If yes, please specify
*Event stopped Date

Action taken after reaction: Did reaction subside after stopping / reducing the
Dose stopped dose of the suspected product?
Dose reduced Yes No Not applicable
Did reaction appear after reintroducing the suspected product?
No action taken Yes No Not applicable
Seriousness of the adverse event: *Outcomes attributed to the adverse event:
Not serious
Hospitalization or prolongation of hospitalization Recovered
Disability or permanent damage Recovered/ resolved with specula
Congenital anomaly / birth defect Not recovered
Life threatening Unknown
Death Fatal (date of death:______________)
Other Medically important
Other relevant history : (pre-existing medical history)
Hypersensitivity Allergies Liver, Heart or Kidney problems Smoking Alcohol Diabetes
Others (Please specify) :

D. OTHER CONCOMITANT MEDICINE INFORMATION

Brand Name Generic name Indication Dosage form Strength & Frequency

E. *REPORTER INFORMATION

*Name & Address__________________________________________________________________________________________________________________________

*Email address *Mobile phone *Occupation______________________________________

*Date of this report submission Signature ___________________

Evaluation/Review Committee Comments:

ADRM Cell TSC ADRAC

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* Mandatory Information P.T.O
General instructions for completing the form : What to report :
Detailed information about each field can be found Serious adverse drug reactions
in the instructions available in the DGDA website. Unknown or unexpected ADRs
([Link]). All suspected reactions to new drugs
Unexpected therapeutic effects
Fill in as much information as possible. Do not All suspected drug interactions
leave anything blank. If unknown, write “unknown” Product quality problems
or “n/a” if not applicable. Treatment failures
Medication errors
Additional pages can be used/added if necessary

How to report :
Suspected drug-related reactions can be reported using by fillable pdf form, which is available in DGDA website
([Link]).
ADE reports can be submitted via email ([Link]@[Link] / [Link]@[Link]), post, or by fax
(+8802 9880854). In emergency cases or when forms are not readily available, reports can sent also be made
to the ADRM cell by phone (+8802 9880803).
ADE reports can also be submitted through the following dgda mobile app:
[Link]

Send all completed forms to:

Directorate General of Drug Administration Aushad Bhavan, Mohakhali, Dhaka-1212, Bangladesh
Tel : 8802 9880803, 9880964, 9880897, 9880924, Fax : 8802 9880854,
E-mail : [Link]@[Link], [Link]@[Link]

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