{"id":6021,"date":"2019-12-23T07:23:03","date_gmt":"2019-12-23T07:23:03","guid":{"rendered":"https:\/\/www.dailyrounds.org\/blog\/?p=6021"},"modified":"2019-12-23T07:23:03","modified_gmt":"2019-12-23T07:23:03","slug":"fda-flags-safety-alert-over-top-neurological-drugs-used-in-india","status":"publish","type":"post","link":"https:\/\/www.dailyrounds.org\/blog\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\/","title":{"rendered":"FDA flags safety alert over top neurological drugs used in India"},"content":{"rendered":"

\"\"A new warning from the US FDA has put the top-selling drugs, gabapentin and pregabalin, sold in India to treat neurological disorders under the blacklist. The U.S. Food and Drug Administration (FDA) has warned serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors.
\nThese drugs are commonly known as \u201cgabapentinoids\u201d drugs. FDA approved these drugs for a variety of reasons including seizures, nerve pain, and restless legs syndrome. Gabapentinoids are sold by several top companies in India, including Pfizer, Sun Pharma, Torrent Pharmaceuticals, Cipla, Lupin and Cadila Pharmaceuticals.
\nFDA reviewed several sources of data, including case reports submitted to FDA or published in the medical literature, observational studies, clinical trials, and animal studies. Among 49 case reports submitted to the FDA over the five years from 2012 to 2017, 12 people died from respiratory depression with gabapentinoids, all of whom had at least one risk factor. This number includes only reports submitted to FDA.
\n\u201cThe FDA is warning that serious breathing difficulties may occur in patients using gabapentin or pregabalin, who have respiratory risk factors,\u201d the FDA said in a statement.<\/a>
\nFDA also reviewed the results of two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals. One trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function. The other trial showed gabapentin alone increased pauses in breathing during sleep. The three observational studies at one academic medical centre showed a relationship between gabapentinoids given before surgery and respiratory depression occurring after different kinds of surgeries.
\nGabapentin was first approved in 1993 and pregabalin in 2004.
\nReacting to the FDA warning, a senior official of Indian drug quality regulator Central Drugs Standard Control Organisation said, \u201cWe will study the observations of US FDA in detail and act accordingly.\u201d But FDA said: \u201cWe require new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids.\u201d
\n\u201cWe have also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential with opioids. Special attention will be paid to the respiratory depressant effects during this abuse potential evaluation,\u201d it added.<\/p>\n

Source: The print, FDA<\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

A new warning from the US FDA has put the top-selling drugs, gabapentin and pregabalin, sold in India to treat neurological disorders under the blacklist. The U.S. Food and Drug Administration (FDA) has warned serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk […]<\/p>\n","protected":false},"author":12,"featured_media":6022,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_post_was_ever_published":false},"categories":[5],"tags":[303,631,175,725,695],"class_list":["post-6021","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-drugs","tag-fda","tag-india-healthcare","tag-neurology","tag-world-medical-news"],"yoast_head":"\nFDA flags safety alert over top neurological drugs used in India - DailyRounds<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.dailyrounds.org\/blog\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA flags safety alert over top neurological drugs used in India - DailyRounds\" \/>\n<meta property=\"og:description\" content=\"A new warning from the US FDA has put the top-selling drugs, gabapentin and pregabalin, sold in India to treat neurological disorders under the blacklist. The U.S. Food and Drug Administration (FDA) has warned serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.dailyrounds.org\/blog\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\/\" \/>\n<meta property=\"og:site_name\" content=\"DailyRounds\" \/>\n<meta property=\"article:published_time\" content=\"2019-12-23T07:23:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.dailyrounds.org\/blog\/wp-content\/uploads\/2019\/12\/prega.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1800\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"DailyRounds\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"DailyRounds\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\\\/\"},\"author\":{\"name\":\"DailyRounds\",\"@id\":\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/#\\\/schema\\\/person\\\/f1f8f4904507b9ce4c90c65c9c06f454\"},\"headline\":\"FDA flags safety alert over top neurological drugs used in India\",\"datePublished\":\"2019-12-23T07:23:03+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\\\/\"},\"wordCount\":388,\"commentCount\":0,\"image\":{\"@id\":\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/wp-content\\\/uploads\\\/2019\\\/12\\\/prega.jpg\",\"keywords\":[\"drugs\",\"FDA\",\"India healthcare\",\"Neurology\",\"World medical news\"],\"articleSection\":[\"Blog\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\\\/\",\"url\":\"https:\\\/\\\/www.dailyrounds.org\\\/blog\\\/fda-flags-safety-alert-over-top-neurological-drugs-used-in-india\\\/\",\"name\":\"FDA flags safety alert over top neurological drugs used in India - 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