NEW DELHI: Alerted by the Union Health Ministry’s pharmaceutical watchdog, the National Co-ordination Centre of the Pharmacovigilance Programme of India (PvPI), on adverse reactions that were being reported from some commonly-used antibiotics, the Central Drugs Standard Control Organisation (CDSCO) has now asked manufacturers to ensure that this information be made available to the general public.
CDSCO has written to drug manufacturers, to mention in leaflets inserted into drug packets or on promotional literature, information about the adverse reactions of these medicines.
All of the seven formulations — antibiotics Cefotaxime, Ofloxacin and Cefixime; Tranexamic Acid, used to control bleeding; antipsychotic drug Quetiapine; anti-rheumatoid drug Sulfasalazine and the anti-epileptic medicine Sodium Valproate — have been instructed to warn patients of the “new” side effects. The letter was sent out by CDSCO on April 9.
Speaking about the decision, Eswara Reddy, the Drug Controller General of India and head of the CDSCO said, “We were alerted to this adverse reaction last year and, after talks with the Ministry and the PvPI, the decision was taken to write to all State authorities to ask manufactures to include this information on the packaging itself. The idea is to ensure that doctors and users are aware of the adverse reactions.”
Additional reaction
“All zonal and sub-zonal officers have been instructed to direct the manufacturers of these formulations to mention the additional reaction in the package insert or promotional literature of the drug,” notes the letter sent the State Drug Controllers.
The Union Health Ministry was alerted about the adverse reactions last year in August.
Antibiotic Cefixime is used to treat a wide variety of bacterial infections and is known to have adverse reactions, including pain, diarrhoea, nausea and headaches.
