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US flags two top neurological drugs used in India, warns of serious breathing difficulties

US Food and Drug Administration says gabapentin and pregabalin drugs, sold in India to treat neurological disorders, may also harm nervous system.

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New Delhi: The US Food and Drug Administration (FDA) Thursday warned against consumption of top-selling drugs — gabapentin and pregabalin that are sold in India to treat neurological disorders — as they may cause “serious breathing difficulties”. 

These drugs are commonly known as “gabapentinoids” drugs.

Approved for a variety of conditions, including seizures, nerve pain from spinal cord injury, shingles and restless legs syndrome — gabapentinoids are sold by several top companies in India, including Pfizer, Sun Pharma, Torrent Pharmaceuticals, Cipla, Lupin and Cadila Pharmaceuticals.

“The FDA is warning that serious breathing difficulties may occur in patients using gabapentin or pregabalin, who have respiratory risk factors,” the FDA said in a statement.

The American health regulator also said if patients suffering from chronic obstructive pulmonary disease (COPD) take gabapentinoids drugs along with opioid pain medicines, then it may harm their central nervous system. 

“The elderly are also at a higher risk,” the FDA added. 

Gabapentinoids are commonly prescribed by neurologists in India, especially to treat back or nerve pain.  

“Over 33 per cent of my patients are either on gabapentin and pregabalin. The profile of both drugs is almost the same with no major difference and both are equally popular with all neurosurgeons. Generally, it is prescribed to people suffering from some kind of back or nerve pain, which radiates towards legs or arms,” said Dr Rahul Gupta, a neurologist at Fortis Hospital in Noida.

Also read: Torrent Pharma warned by US again, this time for using bacteria-contaminated water system

Growing sales of drugs in India 

Fairly old in the Indian market, gabapentin was first approved in 1993 and pregabalin in 2004.

These drugs, which are sold under the brand names of Lyrica, Lyrica CR, Pregeb, Gabacip and Gabantin, have registered a sale of over Rs 300 crore in India from January to November 2019, according to data by IQVIA, a health information company. In combination with other drugs, gabapentinoids recorded a sale of Rs 700 crore, the data showed.

Gabapentin and pregabalin registered sales worth Rs 97.1 crore and Rs 216.8 crore, respectively, until November 2019 — posting a decent increase of 25 per cent and 16 per cent from 2017 when the figures stood at Rs 77.9 crore and 187.7 crore.

Risks FDA noted

As many as 49 case reports were submitted to the FDA over a five-year period from 2012. These reports showed that 12 people died from “respiratory depression” arising from the use of gabapentinoids, according to the FDA.

Also tested on healthy individuals and animals, the trials showed that using pregabalin alone and using it with an opioid pain reliever can affect breathing function. “The other trial showed gabapentin alone increased pauses in breathing during sleep,” the FDA said.

Will study FDA warning in detail, then act, says India

Reacting to the FDA warning, a senior official of Indian drug quality regulator Central Drugs Standard Control Organisation said, “We will study the observations of US FDA in detail and act accordingly.” 

However, the US FDA has planned several actions.   

“We require new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.”

“We have also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential with opiods…Special attention will be paid to the respiratory depressant effects during this abuse potential evaluation,” it added.

Also read: Indians pay 70% less than the global median to buy medicines, study finds


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  1. I Am From The United States Of America And Lyrica Is Use Widely For Nerve Pain, Under Pain Management.
    Some Times A Little Dizziness,That Goes Away.

  2. The problem mentioned here is not primarily due to gabapentin or pregabalin, but due to opioids.
    This article is unnecessarily published without knowing prescribing practises in India.

  3. It’s an obvious standard practice of experimentation & then retrieval of the expenses incurred in the form of business management through poor, less literate, unprivileged,3rd,4th world countries of the globe by the so called 1st world countries,ultimately shrugging all off after retrieval & then jump for another business in the pretext of pharmaceutical upliftment/business to get the rest of the vagabonds drenched and floored under the ground.So,what is new in it? * You have to find your survival mode!👍

  4. Absolute fear mongering article. Most common use in India for gabapentinoids is diabetic neuropathy, also there are no opiod combinations available in India. Patients who are actually getting benefitted may stop using these drugs just because you posted something from the FDA. Do you know paracetamol can cause death? Why don’t you make an article on that?

  5. The title and tilt of the article is misleading. These are standard drugs, discovered and developed in the west, snd sold all over the world for decades. Side effects have been reported now and the FDA has paid heed to them. Hence the warning. Good that you report that. Your headline makes it seem that these drugs are exclusively used in India, or that the rest of the world has stopped using them. We will soon be bombarded by messages suggesting that Indian doctors are using drugs that are ‘banned’ in the West.
    An appropriate way to report this would have been to highlight the FDA decision, and add that these drugs are ALSO commonly used in India, like in all other countries across the world..

  6. The author of this article has not studied the full research article. I am a physician and I have read the article in full. The risk of respiratory depression is mostly in people who are concurrently taking opioids which are rarely used in India on OP basis and there are very tight controls enough to frighten Indian doctors from using them.
    Other risk factors such as COPD or elderly is already known to Indian doctors but the risk is nowhere as that of opioids. These drugs are a different class and far safer than using opioids.
    Please read the article completely and if you do not understand medical science, ask a proper doctor to read it completely and convey the meaning to you. Don’t use your own harebrained interpretation making every research article into an alarmist journalist article.

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