Include Tramadol associated Hiccups In Patient Information Leaflet: CDSCO Panel
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has issued recommendations stating that CDSCO should request state drugs controllers to direct the manufacturers of the opioid analgesic Tramadol to include Tramadol associated hiccups in the Patient Information Leaflet (PIL) of the marketed products in the country.
This was in line with the recommendations of the signal review panel, which were presented to the committee along with the additional data received from the Pharmacovigilance Programme of India—Indian Pharmacopoeia Commission (PvPI—IPC).
Tramadol is a centrally-acting opioid agonist and SNRI (serotonin and norepinephrine reuptake inhibitor) used for the management of moderate to severe pain in adults.
Tramadol is a centrally acting μ-opioid receptor agonist and SNRI (serotonin/norepinephrine reuptake-inhibitor) that is structurally related to codeine and morphine. Tramadol binds weakly to κ- and δ-opioid receptors and to the μ-opioid receptor with 6000-fold less affinity than morphine.
Tramadol is used for the short-term relief of moderate to severe pain. It should only be used when other forms of non-opioid pain relief have not been successful in managing pain or are not tolerated. Tramadol is not usually recommended for the treatment of chronic (long-term) pain.
A few brands of Tramadol include Ranbaxy’s TRAMBAX tab (Tramadol 50mg), TRAMBAX OD tab (Tramadol 100mg), Alkem’s TRUMP inj (Tramadol 50 mg/mL) and others.
Earlier, the recommendation of the signal review panel regarding the Tramadol associated hiccups was deliberated in the SEC meeting dated April 11, 2019.
Now, in continuation, at a recent SEC meeting for analgesic and rheumatology, the recommendation of the signal review panel, PVPI, IPC, was appraised to the committee along with the additional data as received from PVPI, IPC.
After detailed deliberation, the committee recommended,
"CDSCO should request the State Drugs Controller to direct the manufacturers of the drug to include Tramadol associated Hiccups in the PIL of the drug marketed in the country."
