{"id":976,"date":"2026-03-24T12:23:49","date_gmt":"2026-03-24T19:23:49","guid":{"rendered":"https:\/\/www.getasecondopinion.ai\/blog\/?p=976"},"modified":"2026-03-24T12:23:50","modified_gmt":"2026-03-24T19:23:50","slug":"new-fda-warning-carbidopa-levodopa-can-cause-vitamin-b6-deficiency-and-seizures-what-patients-need-to-know","status":"publish","type":"post","link":"https:\/\/www.getasecondopinion.ai\/blog\/policy-alerts\/fda-updates\/new-fda-warning-carbidopa-levodopa-can-cause-vitamin-b6-deficiency-and-seizures-what-patients-need-to-know\/","title":{"rendered":"New FDA Warning: Carbidopa &#038; Levodopa Can Cause Vitamin B6 Deficiency and Seizures\u00a0 &#8211;\u00a0 What Patients Need to Know"},"content":{"rendered":"\n<p>The FDA has told drug makers to add a warning to all products containing <a href=\"https:\/\/www.getasecondopinion.ai\/medication\/carbidopa\">carbidopa<\/a> &amp; <a href=\"https:\/\/www.getasecondopinion.ai\/medication\/levodopa\">levodopa<\/a>\u00a0 &#8211;\u00a0 the most common medicines for <a href=\"https:\/\/www.getasecondopinion.ai\/condition\/parkinson-s-disease\">Parkinson\u2019s symptoms<\/a>\u00a0 &#8211;\u00a0 because these drugs can lower vitamin B6 (<a href=\"https:\/\/www.getasecondopinion.ai\/medication\/pyridoxine-hci\">pyridoxine<\/a>) and have been linked to vitamin B6 deficiency\u2013associated seizures. The agency reviewed reports and asked manufacturers to update prescribing information so health care professionals will check B6 levels before and during treatment and give supplements when needed.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What you should know<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Number of cases reviewed by FDA: 14 (13 from the FDA adverse event system and 1 from medical literature).<\/li>\n\n\n\n<li>All reviewed cases involved levodopa doses >1,000 mg\/day; higher doses were linked to faster onset.<\/li>\n\n\n\n<li>Nine patients\u2019 seizures stopped after vitamin B6 supplementation; two deaths were reported in patients with low B6 and uncontrolled seizures.<\/li>\n\n\n\n<li>The risk was seen across oral tablets, enteral suspensions, and infusion products that deliver carbidopa\/levodopa or their prodrugs.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why this happens<\/strong><\/h3>\n\n\n\n<p>Levodopa is converted into dopamine in the brain. That conversion and the way carbidopa works can use up or block the active form of vitamin B6, lowering the body\u2019s available B6. Low B6 can, in some people, lead to seizures&nbsp; &#8211;&nbsp; sometimes severe.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What patients and caregivers should do right now<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Do not stop your medication suddenly.<\/strong> Stopping levodopa abruptly can be dangerous.<\/li>\n\n\n\n<li><strong>Ask your prescriber for a baseline vitamin B6 blood test<\/strong> and periodic checks if you\u2019re on carbidopa\/levodopa, especially at higher doses.<\/li>\n\n\n\n<li><strong>Watch for warning signs:<\/strong> new seizures, confusion, numbness\/tingling, mood changes, or unexplained weakness. Seek emergency care for any seizure.<\/li>\n\n\n\n<li>If your clinician recommends <strong>vitamin B6 supplementation<\/strong>, follow their dose and monitoring plan\u00a0 &#8211;\u00a0 in reported cases, supplementation resolved seizures.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What to ask your clinician<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Question to ask<\/strong><\/td><td><strong>Why it matters<\/strong><\/td><\/tr><tr><td>\u201cCan we check my vitamin B6 level now?\u201d<\/td><td>Establishes a baseline.<\/td><\/tr><tr><td>\u201cIs my levodopa dose above 1,000 mg\/day?\u201d<\/td><td>Higher doses were common in reported cases.<\/td><\/tr><tr><td>\u201cShould I take vitamin B6 supplements?\u201d<\/td><td>Some patients\u2019 seizures stopped after B6 was given.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<div class=\"wp-block-group unauthenticated invisible has-global-padding is-layout-constrained wp-container-core-group-is-layout-675f737c wp-block-group-is-layout-constrained\" style=\"padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<div class=\"wp-block-group cta-background has-custom-off-white-background-color has-background has-global-padding is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-64f51f8a wp-block-group-is-layout-constrained\" style=\"border-style:none;border-width:0px;border-radius:30px;padding-top:var(--wp--preset--spacing--30);padding-right:var(--wp--preset--spacing--30);padding-bottom:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);box-shadow:var(--wp--preset--shadow--natural);background-image:url(&apos;https:\/\/getasecondopinion.ai\/blog\/wp-content\/uploads\/2025\/09\/cta-background-01.webp&apos;);background-position:100% 100%;background-repeat:no-repeat;background-size:contain;background-attachment:scroll;\">\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-153751c2 wp-block-group-is-layout-constrained\" style=\"padding-bottom:10px\">\n<h3 class=\"wp-block-heading has-text-align-center has-accent-1-color has-text-color has-link-color has-large-font-size wp-elements-b6fe6b9c1e90c3ca0e3d22a4a0e21d9e\">Better Treatment, Lower Cost &#8211; No Catch.<\/h3>\n\n\n\n<p>Find safer, more effective medications with fewer side effects &#8211; often for less money. It\u2019s fast, free, and personalized. <strong><a href=\"https:\/\/getasecondopinion.ai\/intro-summary\" target=\"_blank\" rel=\"noreferrer noopener\">Learn More \u2192<\/a><\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Source<\/strong><\/h3>\n\n\n\n<p><strong>FDA&nbsp; &#8211;&nbsp; <\/strong>Drug Safety Communication: FDA Is Requiring Warning about Vitamin B6 Deficiency and Associated Seizures for Drug Products Containing Carbidopa\/Levodopa<strong><br><\/strong><a href=\"https:\/\/www.fda.gov\/media\/191605\/download?attachment\">https:\/\/www.fda.gov\/media\/191605\/download?attachment<\/a> . .<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has told drug makers to add a warning to all products containing carbidopa &amp; levodopa\u00a0 &#8211;\u00a0 the most common medicines for Parkinson\u2019s symptoms\u00a0 &#8211;\u00a0 because these drugs can lower vitamin B6 (pyridoxine) and have been linked to vitamin B6 deficiency\u2013associated seizures. The agency reviewed reports and asked manufacturers to update prescribing information so [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":978,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[728,352,729,732,734,733,735,730,727,731],"class_list":["post-976","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda-updates","tag-carbidopa-levodopa","tag-drug-safety-alert","tag-fda-warning","tag-medication-monitoring","tag-neurological-side-effects","tag-parkinsons-medication","tag-patient-health-advisory","tag-pyridoxine-test","tag-seizure-risk","tag-vitamin-b6-deficiency"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>New FDA Warning: Carbidopa &amp; Levodopa Can Cause Vitamin B6 Deficiency and Seizures\u00a0 -\u00a0 What Patients Need to Know - Get a Second Opinion<\/title>\n<meta name=\"description\" content=\"FDA warns carbidopa &amp; levodopa may cause vitamin B6 deficiency and seizures. 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