Hyderabad: Two suspected drugs Dabigartan and Sertraine that are leading to severe adverse events in the vision and also the neuro system must be reported to the Pharmacovigilance Programme of India (PvPI) as the prescription of these drugs has to be revised.
The alert has been issued by the Indian Pharmacopoeia Commission after 20 of 250 ADR centres reported the adverse effects.
Dabigartan and Sertraline were found to cause unpredictable hair loss, and damage to the macula, the part of the eye which is responsible for the central vision.
Dabigartan is recommended for prevention of stroke, systemic embolism, and reduction of vascular mortality in adult patients with cardiovascular diseases. Sertraline is given for major depressive disorders, obsessive compulsive disorder and panic disorders.
The Indian Pharmacopoeia Commission, which has been set up for PvPI, has directed healthcare professionals to report adverse events to the website in the format available.
With ADR monitoring centres set up in the country, the director of pharmaceuticals is keen that ADR's reporting must be done to strengthen patient safety.
The ADRs will create a data bank for the drugs and these can then be used as a basis during prescription.
Dr V.A. Achary, senior pharmacologist explained, “ADR are important for the doctors to understand what the possible side-effects are, and in how much quantity it must be prescribed. An ADR will also help in choosing the combination drugs as drug-to-drug interaction also leads to different side-effects. Hence this will help doctors make better decisions in terms of prescription of the drugs.”
