English | Hindi | Spanish | Deutch
+91-11-23370009hsg@ima-india.org

Drug Safety Alert November 2016


File No. IPC/NCC-PvPI/DSA/2016-17/07                                                                     November 2016

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 (http://www.ipc.gov.in) or by PvPI Helpline No. 1800-180-3024.