November 2016
File No. IPC/NCC-PvPI/DSA/2016-17/07
Drug Safety Alerts
The preliminary analysis of SUSARs from the PvPI database reveals that the following drugs are associated with the risks as given below.
Table
|
Sl.No |
Suspected Drugs |
Indication |
Adverse Reactions |
|
1 |
Cabergoline |
For the treatment of hyperprolactinemia and inhibition of lactation |
Steven Johnson Syndrome |
|
2 |
Amlodipine |
Angina, hypertension, Coronary artery disease |
Alopecia |
|
3 |
Nitrofurantoin |
Urinary tract infections; cystitis |
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) |
|
4 |
Cefoperazone Sulbactam |
For treatment of RTI, UTI (lower & upper), Septicemia, Meningitis, Skin & Soft tissue infection, Endometritis, Other infection of genital tract, Intra abdominal infection bone & joint infection |
Acute Generalised Exanthematous Pustulosis (AGEP) |
Health care professionals, Patients/Consumers are advised to closely monitor the possibility of the above adverse events while prescribing/consuming above suspected drugs and report to the NCC-PvPI either by filling of Suspected Adverse Drug Reactions Reporting Form/
Medicines Side Effect Reporting Form for Consumer (https://www.ipc.gov.in) or by PvPI Helpline No. 1800-180-3024.