Drug-Makers to add urinary retention as ADR in package insert of Tramadol

This came in line with the recommendation of the signal review panel of National Coordinating Centre(NCC) -Pharmacovigilance Programme of India (PvPI), which was placed before the committee.

Tramadol is a centrally acting synthetic opioid analgesic. It 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 approved for the management of moderate to severe pain in adults. Tramadol is also used off-label in the treatment of premature ejaculation.

It is reported from the signal review panel of the National Coordinating Centre- Pharmacovigilance Programme of India (PvPI), that Tramadol can lead to urinary retention as adverse drug reaction.

Urinary retention is a condition in which one is unable to empty all the urine from the bladder. Urinary retention is not a disease, but a condition that may be related to other health problems, such as prostate problems in men or a cystocele in women.

At a recent SEC meeting for Analgesic & Rheumatology, the recommendation of the signal review panel, PVPI, IPC, was placed before the committee regarding the adverse reaction related to the Tramadol.

In view of the above, after detailed deliberation, the committee recommended,

"CDSCO should request the State Drug Controllers to direct the manufacturers of the drug to include urinary retention as adverse drug reaction in the corresponding package insert of the drug."

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