Adverse Event Definitions and Classifications

Active Drug Safety Monitoring (aDSM) is a proactive effort made to elicit adverse events from patients by directly asking the patient, screening records, and checking laboratory and clinical tests. All adverse events are captured systematically at all patient visits (during treatment initiation, treatment review and extra visits).

Active TB Drug Safety Monitoring [aDSM]

Dysglycaemia is a broad term that refers to an abnormality in blood sugar stability. This can include hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar).

The mitochondrial toxicity of certain anti-TB drugs, such as in the prolonged use of Linezolid (Lzd) (≥28 days), may cause lactic acidosis which is a potentially life-threatening build-up of lactic acid in the body. It is a serious Adverse Drug Reaction (ADR) that can result in multiorgan failure and death.

Such cases must be immediately referred to the nearest higher health centres - District/ Nodal DR-TB Centre (D/NDR-TBC)/ sub-district or district hospital, medical college hospitals, etc.

Superficial fungal infection is a rare and non-serious Adverse Drug Reaction (ADR) to regimens containing fluoroquinolones. It can present as an itchy rash with swelling, discharge and pain. It can also occur in the mouth as oral thrush, which presents with thick white patches on the tongue and cheeks, and sometimes with pain or burning.

Alopecia is a rare, minor Adverse Drug Reaction (ADR) that is observed in patients on regimens with Isoniazid (H) and Ethionamide (Eto). It presents with patchy hair loss, mostly from the scalp. It can be easily identified by field-level health care workers and is often reported by patients on their own.

Figure: Patchy Hair Loss from Scalp (Alopecia)

Suspected agent(s): Isoniazid (H), Ethionamide (Eto)

Electrolyte disturbances are a rare but serious Adverse Drug Reaction (ADR) that can cause symptoms like irregular heartbeat, fatigue or lethargy, convulsions or seizures, nausea, vomiting and muscle spasms. It requires serum electrolyte lab tests for diagnosis.

This ADR is best managed at the Drug-resistant TB (DR-TB) centre where the patient can be admitted and administered treatment.

Suspected agent(s): Amikacin (Am)

Suggested Management Strategies

In optic neuritis, the patient may present with vision loss, peri-ocular pain and dyschromatopsia (a disorder of colour vision). This is a rare but serious Adverse Drug Reaction (ADR) caused by certain anti-TB medications.

Mild forms of this ADR present with episodes of disturbed or blackened rather than blurry vision, reduced night vision, photophobia and red eyes. Serious cases may present with loss of coloured vision and may also progress to demyelinating optic neuritis.

Vestibular toxicity is one of the Adverse Drug Reactions (ADRs) that results in damage of the balance structure in the inner ear leading to loss of balance for the patient.

Suspected agent(s): Amikacin (Am), Cycloserine (Cs), Fluoroquinolones (FQs), Isoniazid (H), Ethionamide (Eto), Linezolid (Lzd)

Suggested Management Strategies