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New Delhi: The American health watchdog, the US Food and Drug Administration (FDA), has asked manufacturers of sleeping pills to print an emphatic warning about the rare but life-threatening side-effects of these drugs on their packaging.

The warning will be printed in a label box — the most prominent of warnings — to ensure that patients and their healthcare professionals take note of the more serious side-effects.

“The new warnings will be required for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist),” said the FDA in a press statement issued Tuesday.

The FDA has stated that under its latest safety review, it has found 66 cases of adverse events in which patients who had taken the drugs were engaged in activities such as driving and sleepwalking while they were not fully awake, leading to the death and injuries.

“46 reports of non-fatal serious injuries included accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures leading to loss of limb or near death, self-injuries such as gunshot wounds and apparent suicide attempts,” FDA said in press release.

It added that “the 20 deaths reported were from carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions with the patient driving and apparent suicide”.

The sleeping pills under question — eszopiclone, zaleplon, and zolpidem — are prescribed to help patients fall asleep faster and sleep for longer. They are sold under different brand names in India.

They belong to a group of medicines known as ‘sedative-hypnotics’, which work by slowing the activity of nerve cells in the brain. Their common side effects include sleepiness, dizziness, uncoordinated body movements, nervousness and headache.


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Usage in India

In India, around 60 brands of sleeping pills are made from the three listed formulations and are manufactured by top pharma companies, including Cipla, Sun Pharmaceuticals, Abbott and Ipca laboratories.

In last one year, the off-line pharmacies have sold more than 37 lakh units of these sleeping pills amounting to the turnover of Rs 200 crore, according to the data by AIOCD- AWACS, a research and data wing of chemist lobby, All India Organisation of Chemists and Druggists (AIOCD).

“All these drugs are commonly prescribed in India not only by psychiatrists but by all doctors,” said Dr Anita Mahajan, a psychiatrist at Sir Ganga Ram Hospital, New Delhi. “These drugs are otherwise safe when used in the prescribed conditions and have proved beneficial in putting patients to sleep when they are in pain or extreme trauma,” she said.

“The FDA’s notification to include boxed warning is also a welcome move as it brings to our notice, the rare but scary side effects,” Mahajan added.

Indian drug makers, however, said the labelling is a routine process.

“It’s a normal regulatory process of marking the cautions on labels,” said Ashok Madam, executive director, Indian Drug Manufacturers’ Association (IDMA), the country’s largest pharma lobby with over 1,000 pharma companies as its members.

The Indian drug regulator, the Central Drugs Standard Control Organisation (CDSCO), is yet to respond to the development.


Also read: Nearly 20% of all pharma products sold in India are counterfeit, US trade body claims 


 

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