New Delhi: The Modi government has asked over 100 drug makers to add the strongest warning on the box of antidepressant Escitalopram, which has been linked to suicidal thinking and other impairments, ThePrint has learnt.
In an order dated 3 February, the Central Drugs Standard Control Organisation (CDSCO), the country’s apex drug regulator, asked 102 drug makers — including big pharmaceutical companies like Sun Pharma, Cipla and Glenmaker — to update the boxed information so that it accurately reflects the possible side-effects of the drug.
Escitalopram is used for treatment against depression and anxiety but the side-effects include the possibility of impairment in thinking, judgement and motor coordination. In the US, it has carried a ‘black boxed warning’ since 2004 — the strongest warning against a drug issued by the country’s Food and Drug Administration (FDA).
The CDSCO order, which has been accessed by ThePrint, highlighted the FDA’s boxed warning on the risk of “suicidal thinking” in children, adolescents and young adults taking the drug.
“It is hereby requested that all pharmaceutical companies engaged in manufacturing and marketing of subject drugs are required to update their prescribing information for larger interest of the public health safety,” the order, which is also marked to all state drug controllers and the National Medical Commission (NMC), said.
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CDSCO to examine prescribing info, package inserts
The order, titled ‘Addition of Boxed Warning ‘Suicidality and Antidepressant drugs’, noted that the drug regulator has also started examining the warnings, prescribing information and package inserts given by Indian drugmakers with the drug.
“This office is in the process of examining prescribing information or package insert for Escitalopram and its combinational drug formulations,” said the order issued by Somnath Basu, assistant drugs controller.
The CDSCO also asked pharmaceutical companies to provide “scientific and medical justification” available with them on the drug.
They have also been asked to submit details of manufacturing facilities along with the latest “prescribing information” used by them on their drug packs “as soon as possible”.
“Please let us know whether you have manufacturing facilities for the said formulations or you are in a business to business arrangements with some manufacturers,” the order noted.
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Concerns highlighted by regulator over use of drug
The Indian regulator, in the order, mentioned the complete warning mandated by the FDA for Escitalopram.
The 14-line-long warning reads: “Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.”
The drug Escitalopram is sold under the brand name Lexapro in the US.
“Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need,” the warning adds while also noting that the “patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior,” the warning further reads.
The CDSCO also highlighted that using Escitalopram with Clonazepam — a drug used to treat seizures and panic attacks — increases side-effects like dizziness, drowsiness, confusion and difficulty in concentrating.
“Some people especially elderly may also experience impairment in thinking judgement and motor coordination,” the order stated.
It also noted that Escitalopram in combination with Etizolam, which is a sedative-hypnotic drug to reduce insomnia and anxiety, may cause similar side-effects.
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