TABLE 2.
Regulatory actions by DRAP.
| S. No. | Drug | Basis for action | Source of information | Action taken |
|---|---|---|---|---|
| 1. | Systemic fluoroquinolones (DRAP, 2016) | Risk of disabling adverse effects of tendons, muscles, joints, and central nervous system | US-FDA FDA | Prescribing information and labeling information updated, black box warning |
| 2. | Hydroxyzine hydrochloride (DRAP, 2017b) | Abnormal cardiac rhythm | European Medicine Agency (EMA), United Kingdom (MHRA), PMDA (Japan), Health Canada | Prescribing information updated and daily dose reduced |
| 3. | Direct acting hepatitis cantiviral (DRAP, 2017a) | Risk of hepatitis b virus (hbv) reactivation | PMDA (Japan) US-FDA |
Prescribing information updated and box warning |
| 4. | Irrational combination of Paracetamol 500 mg, Thioridazine 3 mg, and caffeine 70 mg (DRAP, 2016) | Withdrawn of Thioridazine worldwide by the brand leader Novartis. Combination not registered in any Stringent Regulatory Authority | Internal review and Novartis Pharma | Cancellation of Registration |
| 5. | Oral ketoconazole (DRAP, 2016) | Potential to cause severe liver injuries | USFDA, European Medicines Agency’s Committee (EMA), Health Canada | Cancellation of Registration |
| 6. | Clarithromycin (DRAP, 2018) | A possible increase in the risk of heart disease | US-FDA | Prescribing information updated |
| 7. | Canagliflozin (DRAP, 2018) | Risk of amputation of lower limb | US-FDA. European Medicines Agency (EMA) | Prescribing information updated, black box warning |