It is a fact that the Adverse Drug Reactions (ADR) of many common drugs are either ignored or unreported due to many reasons. It is the prime duty of the Government to ensure the safety of a drug used to cure a disease condition. The reactions are known or suspected by the healthcare professionals during their day to day activities are to be reported to the nodal agency entrusted to conduct studies on the reported reactions and to initiate remedial measures to prevent further reactions. The Adverse Drug Reactions of drugs are monitored by the Pharma-co-Vigilance Programme of India (PVPI) through its National Coordinating Centre, the Indian Pharmacopoeia Commission (IPC), under The Ministry of Health & Family Welfare, Government of India, Sector-23, Raj Nagar, and Ghaziabad-201002. They are committed to assuring Safety of drugs by regular monitoring of the ADRs through its ADR monitoring Centers throughout India, attached to major Hospitals & Medical Colleges.
The Causality Assessment of the reported ADR from the Health Care Professionals is carried out at the AMCs by using WHO-UMC Scale. The ADRs reported are treated as serious when the patient outcome is Death, Life-threatened, Hospitalization, Disability, Congenital Anomaly or requiring intervention to prevent permanent impairment or damage.
For Voluntary Reporting of ADRs by Healthcare professionals, specific reporting forms are available on the CDSCO website. (www.cdsco.nic.in). It is the duty of the health care professionals to report the ADRs to the AMCs for timely monitoring and scientific management to take remedial action on time. The details of the reporting person will be hidden by the AMCs so as to protect them from any future problems.
SOME ADVERSE DRUG REACTIONS CAUTIONED BY THE PVPI THROUGH NEWS LETTERS
[NAME OF THE DRUG – REPORTED SYMPTOM
1. Measles Rubella Vaccine – Guillain Barre Syndrome ( a condition in which the immune system attacks the nerves, leading to muscle weakness and paralysis)
2. Terbinafine (antifungal)- Acute Generalised Exanthematous Pustulosis (AGEP)
3. Triamcinolone -Skin Peeling
4. Clindamycin – AGEP, develops within 5 days as sudden skin eruptions
5. Dapsone – Erythema Nodosum (acute nodular skin inflammations)
6. Levetiracetam – Hypokalemia ( low potassium in blood)
7. Fluoxetine – Urinary Incontinence ( Loss of bladder control)
8. Ceftriaxone – Palpitations (racing heart beats)
9. Quetiapine – Gynaeco mastia ( Swollen male breast)
10. Allopurinol – Uveitis (an inflammation of the middle layer of the eye)
11. Linagliptin – AGEP
12. Acetazolamide – Drug Hypersensitivity Syndrome (severe skin reaction)
13. Cefixime – Skin Hyper pigmentation ( darkened spots on the skin)
14. Fluoxetine – Hypoacusis (Hearing loss)
15. Levetiracetam -Anencephaly( baby born with defective brain& skull)
16. Cetrizine -Tachycardia]**Do in Box
