Add Haloperidol linked cogwheel rigidity in package insert: CDSCO Panel
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has recommended that CDSCO should request the State Drugs Controllers to direct the manufacturers to include adverse drug reaction (ADR) of Haloperidol associated cogwheel rigidity in the package insert of antipsychotic medication Haloperidol.
Cogwheel phenomenon, also known as cogwheel rigidity or cogwheeling, is a type of rigidity seen in people with Parkinson's disease. Cogwheel rigidity is one of the criteria for the diagnosis of idiopathic Parkinson disease and is often an early sign of the disease. Clinically, it is characterized by muscular stiffness throughout the range of passive movement in both extension and flexion.
Muscle will be stiff in cogwheel rigidity, as it is in other types of rigidity. However, the same muscle may tremble when the person is at rest. Cogwheel rigidity can affect any limb, but it's most common in the arms. It can affect one or both arms.
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.
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Haloperidol is a high potency first-generation (typical) antipsychotic and one of the most frequently used antipsychotic medications used worldwide.
While haloperidol has demonstrated pharmacologic activity at a number of receptors in the brain, it exerts its antipsychotic effect through its strong antagonism of the dopamine receptor (mainly D2), particularly within the mesolimbic and mesocortical systems of the brain.
Haloperidol is indicated for the treatment of the manifestations of several psychotic disorders including schizophrenia, acute psychosis, Tourette syndrome, and other severe behavioural states.
A few brands of Haloperidol include Torrent Pharma's Hexidol (1.5 mg), Sun Pharma's Senorm (10 mg,5mg), Intas Pharma's Trancodol (1.5 mg), etc.
At a recent SEC meeting for Neurology & Psychiatry, the recommendation of the signal review panel, PVPI, IPC, was placed before the committee regarding the adverse reaction of Haloperidol associated cogwheel rigidity.
In view of the above, after detailed deliberation, the committee recommended,
"CDSCO should request the State Drugs Controllers to direct the manufacturers to include ADR of Haloperidol associated cogwheel rigidity in the package insert of the drug marketed in the country."
