{"id":353397,"date":"2016-04-04T10:46:56","date_gmt":"2016-04-04T15:46:56","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/why-drugs-get-pulled-from-the-market.html"},"modified":"2023-11-13T09:13:00","modified_gmt":"2023-11-13T14:13:00","slug":"why-drugs-get-pulled-from-the-market","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/why-drugs-get-pulled-from-the-market.html","title":{"rendered":"Why Drugs Get Pulled From the Market"},"content":{"rendered":"\n<div class=\"wp-container-core-columns-is-layout-9d6595d7 fl-sectionWithSidebar fl-container fl-flex fl-flex-wrap fl-gap30\">\n<div class=\"fl-page-articles fl-section-main fl-section-main-full-width\"><h1 class=\"fl-no-margin-top\">Why Drugs Get Pulled From the Market<\/h1>\n\n<section class=\"fl-gutenberg-byline\">\n    <div class=\"fl-gutenberg-byline-content\">\n                    By <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/christie-nicholson-j-d\/\">Christie Nicholson, J.D.<\/a> | Legally reviewed by <a\n                href=\"https:\/\/www.findlaw.com\/company\/our-team\/oni-harton-j-d\/\">Oni Harton, J.D.<\/a>\n                | Last updated\n        <time>\n                            November 13, 2023\n                    <\/time>\n    <\/div>\n\n    \n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-legally-reviewed\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Legally Reviewed\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>This article has been written and reviewed for legal accuracy, clarity, and style by <a href=\"https:\/\/www.findlaw.com\/company\/our-team.html\">FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with <a href=\"https:\/\/www.findlaw.com\/company\/company-history\/editorial-policy.html\">our editorial standards<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n\n    <details class=\"fl-gutenberg-byline-toggle fl-gutenberg-byline-fast-checked\">\n        <summary>\n            <i class=\"fl-gutenberg-byline-icon\" aria-hidden=\"true\"><\/i>\n            Fact-Checked\n        <\/summary>\n\n        <div class=\"fl-gutenberg-byline-toggle-content\">\n            <p><em>The last updated date refers to the last time this article was reviewed by FindLaw or one of our <a href=\"https:\/\/www.findlaw.com\/company\/our-team\/contributing-authors.html\">contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please <a href=\"https:\/\/lawyers.findlaw.com\/?fli=bylinelink\" target=\"_blank\" rel=\"noopener\">contact an attorney in your area<\/a>.<\/em><\/p>\n\n        <\/div>\n    <\/details>\n<\/section>\n\n\n    <div class=\"fl-callout-text article-blockquote\">\n        <div data-testid=\"loading-message\" data-fui-focus-visible=\"\">\n<div>\n<div id=\"chatMessageResponser2f\" class=\"___1yop6mf f336tjw f9ijwd5 fz7g6wx fod5ikn f1s184ao\" aria-live=\"assertive\">\n<div class=\"___1j4t0a1 f1lmfglv f1abmfm4\" aria-hidden=\"false\" data-testid=\"markdown-reply\" data-message-type=\"Chat\">\n<div class=\"___stpibi0 f22iagw f1vx9l62 fk15e71 f1k953kz f137keqj f1rncccw f1stllg3 f1w4kmmc f1tric3v f10dk5ic fx8cdsv f16nlwsl f1eookvz fhjrts3 fqugt2f f10km5jb f18d18k8 f1v1vhmp f1hdmul3 f198vjnp f2dshw1 fjpjndq fnmj2pj ffrrb40 f1mon110 fhajzam fimndk6 fxv4dng fb1rn9k f59wlhv f1xmfh30 f18yf5o5 fmr6chf fw8qy2q ff161sd f1qr7t77 f1yyogn1 foogchg fp5872b f1tpb8gf f1hdgrc8 f1vatr43 frkxccd f9pdzkb f158oiaz ft5kggy f5l4ui7 f13j03li f18xdoka f8off4e f1go6zfc f128n2ra f1jpxw2j f1lwd9n0 fy0b8hm f1g2633v fx4kvgi fkvolse f1gxrt3a f1os76ua f1js9cnw f1g87ej0 freluf8 f1yggaq6 f2i3chp f1151osp florpoh f35kzfz ftp9m57 f1e288vi fz62hnz fixvuys f1nmofwh fc1c6mv f18a2er7 fhvkrdl fhxnn68 f1oce4bo fvhlfan f7tc0t0 f1ngf1n2 ffrzq6x f1yjiq2m f1aqdgql f1huvaf f10ij78l f1k94sa4 fkmfumq f1jvzkyl f1eu24ob f1xbfc1f fmf0lwf f107dsy8 f3w566c f4648sl f13zpkng f7unjfp f8p1rz fzu6h1w f1i1bi6h f1smo7hi f1sk1xod f1kgogdq f1gjktkp ft608jz f19dd9cz fg3xr24 fhd155k f1b8gl2e fg4b9ou flb4lo fdicbfk fgwcyh1 f1jbds0d f1fb9uea f1stuka4 fcrtu6g fwqh0xn f11w66yg f6e0e65 f1vvgu0 f1607507 f1m9bycv f1ntoah8 f1b694rt faql4r2 fpjuhzh fmavl6h\">\n<p>Drugs are pulled from the market when they are found to pose serious health risks, such as causing harmful side effects or dangerous interactions. The FDA or the manufacturer may initiate a recall or withdrawal due to safety concerns, manufacturing errors, or labeling issues.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n    <\/div>\n\n\n\n<p>Every year, dozens of prescription drugs are either recalled or withdrawn from the market. Some companies recall a medication because the <a href=\"https:\/\/www.fda.gov\/\" target=\"_blank\" rel=\"noopener\">Food and Drug Administration (FDA)<\/a> determines it&#8217;s dangerous. <span style=\"font-size: revert;color: initial\">In some cases, companies withdraw drugs voluntarily for business reasons or to avoid legal and reputational damage.<\/span><\/p>\n<p>The FDA may order a recall after determining a drug poses a health risk. Manufacturers may also ask patients to return their prescriptions to their doctor or pharmacy so manufacturers can try to fix the problem. Other times, the drugmaker permanently pulls a drug from the market.<\/p>\n<p>This article provides an overview of drug recalls and why pharmaceutical companies may pull a medication from the market. It also explains how the recall and withdrawal process works.<\/p>\n<p>Drug manufacturers have a legal responsibility to ensure their drugs carry adequate warnings and are safe to use. If you have been harmed by a pharmaceutical drug, you may have a legal claim. Contact a <a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a> near you to share your story, learn your rights, and explore your options.<\/p>\n<h2>Before the Recall: Regulating Pharmaceutical Drugs<\/h2>\n<p>Drug safety is a continuous effort of those in the healthcare field. Once the FDA\u00a0<a href=\"http:\/\/www.fda.gov\/Drugs\/ResourcesForYou\/Consumers\/ucm143534.htm\" target=\"_blank\" rel=\"noopener\">approves a drug<\/a>, it continues to monitor the medication. The FDA updates drug labels to inform patients about drugs&#8217; adverse side effects, health risks, and interactions.<\/p>\n<p>When a manufacturer receives news of a reported problem, it investigates whether it can resolve it. The FDA also maintains an\u00a0<a href=\"http:\/\/www.fda.gov\/Safety\/MedWatch\/\" target=\"_blank\" rel=\"noopener\">online reporting system<\/a>\u00a0to help educate patients and physicians about the dangers of specific medications and medical devices.<\/p>\n<p>Doctors must familiarize themselves with the warnings and potential dangers of various drugs. This way, they can decide which drugs to prescribe to their patients. At the same time, medical researchers conduct ongoing studies to evaluate the negative impacts of specific medications. They publish their findings so that healthcare providers and patients can decide the best course of treatment.<\/p>\n<p>Ideally, one or all of these efforts can address potential problems with pharmaceutical drugs without <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/dangerous-drugs.html\">requiring a recall<\/a>.<\/p>\n<h2>Reasons for Pulling a Drug From the Market<\/h2>\n<p>It can be challenging for most to understand when and why drugmakers recall or pull a particular drug from the market. Typically, when a drug manufacturer or the FDA learns that a drug poses a health risk to patients, they issue a recall.<\/p>\n<p>Drugmakers and the FDA usually <a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/drug-recalls\" target=\"_blank\" rel=\"noopener\">make recall<\/a> decisions on a case-by-case basis. However, there are some common reasons for issuing a recall:<\/p>\n<ul>\n<li><b>Risk of health problems<\/b>: Sometimes, further study reveals a connection between taking a drug and a potential health problem. For example, some pharmaceutical drugs carry an increased risk of heart attack, stroke, kidney failure, and other adverse reactions.<\/li>\n<li><b>Previously unknown drug interactions and adverse events<\/b>: Mixing drugs can cause health problems. Sometimes, either\u00a0the company\u00a0or the\u00a0FDA\u00a0discovers a medication causes issues when taken with another drug, a specific type of vitamin, or certain foods.<\/li>\n<li><b>Manufacturing and packaging errors<\/b>: Sometimes, the FDA or drug manufacturer learns that there&#8217;s a problem at the factory. They may also identify a contamination problem that may make a drug unsafe for consumption. Sometimes, the company learns that a packaging error unseals a drug before it reaches the U.S. market.<\/li>\n<li><b>Failure to warn issues<\/b>: Sometimes, a pharmaceutical company knows their drug poses certain health risks. When this is the case, they must warn patients and healthcare professionals of these risks. In these situations, the U.S. Food and Drug Administration will order that the drugmaker include a warning label on the drug&#8217;s packaging and marketing materials.<\/li>\n<\/ul>\n<p>Once the FDA or drug company determines it will issue a recall, it must follow steps to safeguard public health.<\/p>\n<h2>How a Recall Works<\/h2>\n<p>Usually, a manufacturer will initiate a\u00a0voluntary recall for an unsafe drug. This may happen for a variety of reasons. Some of the more\u00a0<a href=\"https:\/\/www.health.harvard.edu\/blog\/drug-recalls-are-common-202303292907\" target=\"_blank\" rel=\"noopener\">common reasons<\/a>\u00a0why a drug company would start a voluntary recall or market withdrawal include:<\/p>\n<ul>\n<li>The manufacturer receives an alarming number of reported problems from patients<\/li>\n<li>Research studies or clinical trials determine that a drug increases the risk of serious complications<\/li>\n<li>A problem at a manufacturing plant puts patients at risk<\/li>\n<li>New drugs are not tested sufficiently or adequately before drug approval<\/li>\n<li>Clinical trials fail to reveal specific rare side effects before FDA approval<\/li>\n<li>Participants in a clinical trial are healthier than the drug&#8217;s patient population<\/li>\n<li>Improper labeling of drugs, such as\u00a0lack of safety alerts, disclaimers, or warnings<\/li>\n<li>Problems with drug storage<\/li>\n<li>Illegal or unlawful behavior by drugmakers, such as including prescription medications in over-the-counter remedies<\/li>\n<\/ul>\n<p>While these recalls are technically voluntary, in many cases\u00a0they occur at the FDA&#8217;s request.<\/p>\n<h2>Does the FDA Oversee the Recall Process?<\/h2>\n<p>The FDA works closely with the manufacturers of drug products during a recall. The agency maintains a\u00a0<a href=\"http:\/\/www.fda.gov\/Safety\/Recalls\/default.htm\" target=\"_blank\" rel=\"noopener\">database of product recalls<\/a> for the public. It also assists manufacturers in retrieving their drugs from the market and ensuring the appropriate follow-up.<\/p>\n<p>The agency utilizes a <a href=\"https:\/\/www.fda.gov\/safety\/industry-guidance-recalls\/recalls-background-and-definitions\" target=\"_blank\" rel=\"noopener\">recall classification system<\/a> to highlight the seriousness of the problem. In the USA, the FDA can issue a mandatory recall order for a pharmaceutical drug. While the FDA rarely exercises this power, the threat of it generally encourages manufacturers to take the necessary steps to remove a drug from the market until it resolves any safety issues.<\/p>\n<h2>Types of Product Recalls<\/h2>\n<p>The FDA classifies recalls based on the seriousness of the drug&#8217;s risks. Some of the\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/drugs-and-medical-device-recalls.html\">factors considered<\/a>\u00a0when determining whether to recall a drug include:<\/p>\n<ul>\n<li>Severity of the hazard<\/li>\n<li>Populations impacted by the potential risks (older adults, children, etc.)<\/li>\n<li>The probability of the danger occurring<\/li>\n<li>Number of potential victims<\/li>\n<li>Long-term and short-term consequences of the drug&#8217;s potential hazards<\/li>\n<\/ul>\n<p>After reviewing the above information, the drugmaker or FDA will decide into which class of recall a drug falls.<\/p>\n<p>There are three categories of recalled products. They fall into the following\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/fda-recall-types.html\">three classes<\/a>:<\/p>\n<ul>\n<li><b>Class I recall<\/b>:\u00a0Drugs that pose the most significant risk of injury or death<\/li>\n<li><b>Class II recall<\/b>:\u00a0Medications with lower potential to cause substantial harm or death<\/li>\n<li><b>Class III recall<\/b>:\u00a0\u00a0Drugs that are not likely to cause adverse health effects but still pose a slight chance<\/li>\n<\/ul>\n<p>A company may also issue a market withdrawal. This occurs when a manufacturer pulls a product with a minor violation not subject to an FDA recall from the market. These market withdrawals are not recalls.<\/p>\n<p>With these withdrawals, the manufacturer doesn&#8217;t ask patients to return existing drugs. Instead, the manufacturer stops distributing the medicine. They gradually remove a prescription from the market by cutting off its supply.<\/p>\n<p>Market withdrawals tend to be business decisions. A manufacturer may conclude that falling sales revenue makes selling a drug unprofitable. A manufacturer may also figure that a rise in\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/what-is-product-liability.html\">product liability lawsuits<\/a>\u00a0will damage the brand and hurt the company&#8217;s public image. Ceasing to sell a drug can remove it from the market without attracting the attention of an actual recall.<\/p>\n<h2>Examples of Drugs the FDA Has Recalled Over the Years<\/h2>\n<p>There are hundreds of new drugs introduced to the market every year. While drugmakers are supposed to investigate all new drugs before releasing them to the market, this doesn&#8217;t always happen the way it should.<\/p>\n<p>Some of the medications the FDA or drug manufacturers recalled for safety issues include:<\/p>\n<ul>\n<li>Meridia (sibutramine)<\/li>\n<li>Terfenadine<\/li>\n<li>Cerivastatin<\/li>\n<li>Blood pressure medications<\/li>\n<li>Cholesterol drugs<\/li>\n<\/ul>\n<p>Drugmakers recalled these medications for a host of different reasons. Sadly, pharmaceutical companies don&#8217;t recall most drugs until the FDA or drug manufacturers realize that it has injured hundreds\u00a0or thousands\u00a0of Americans. If this happens to you or your loved one, you should speak with a\u00a0<a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/?fli=dcta\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a>\u00a0near you.<\/p>\n<h2>Need More Help? Contact a Dangerous Drug Attorney<\/h2>\n<p>If you have been negatively affected by a drug, it&#8217;s helpful to speak with a lawyer with experience with drugs and medical devices for more help. Whether the drug has already been recalled or still poses a danger to the public, they can help with all related issues.<\/p>\n<p>FindLaw&#8217;s directory of <a href=\"https:\/\/lawyers.findlaw.com\/drugs-medical-devices\/?fli=dcta\" target=\"_blank\" rel=\"noopener\">product liability attorneys<\/a> can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys\u2019 experience with dangerous drug cases. Many attorneys offer free case evaluations.<\/p>\n\n\n<div class=\"was-this-helpful\">\n    <div\n            class=\"was-this-helpful__question-container\"\n            aria-labelledby=\"was-this-helpful__question\"\n            role=\"group\"\n    >\n        <span\n                id=\"was-this-helpful__question\"\n                class=\"was-this-helpful__question fl-text-lg-bold\"\n        >Was this helpful?<\/span>\n        <button\n                class=\"was-this-helpful__button fl-text-sm\"\n                aria-label=\"Yes\"\n                value=\"yes\"\n        >\n            <span class=\"was-this-helpful__button-text fl-text-bold\">Yes<\/span>\n            <i class=\"was-this-helpful__button-icon\">\n                <svg width=\"22\" height=\"22\" viewBox=\"0 0 22 22\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                    <g id=\"thumbs-up\" clip-path=\"url(#clip0_604_3418)\">\n                        <path id=\"Vector\"\n                            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Injury Lawyers<\/a><\/li>\n                            <\/ul>\n        <\/div>\n    <\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>If a drug\u2019s side effects are unreasonably dangerous, it may be pulled from the market. 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