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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.
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.