{"id":1449,"date":"2026-11-01T11:26:05","date_gmt":"2026-11-01T11:26:05","guid":{"rendered":"https:\/\/healthdailyusa.com\/?page_id=1449"},"modified":"2026-11-01T17:27:31","modified_gmt":"2026-11-01T17:27:31","slug":"fda-issues-warning-on-breast-cancer-drug","status":"publish","type":"page","link":"https:\/\/healthdailyusa.com\/index.php?page_id=1449","title":{"rendered":"HealthDailyUSA.com &#8211; FDA Issues Warning on Breast Cancer Drug"},"content":{"rendered":"\n<div class=\"wp-block-group custom is-layout-flow wp-block-group-is-layout-flow\"><\/div>\n\n\n<div id=\"fb-root\" class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\"><\/div>\n\n\n<div style=\"display: none\">\n  <div id=\"inline1\" style=\"color: #004E98;text-align:center;font: 24px\/32px Calibri;margin-bottom: 10px;line-height:27px;overflow: hidden;width: 490px;height: 270px;padding-left: 8px;margin: auto\">\n    <h1 style=\"font: 48px Calibri\">Thank You!<\/h1>\n    <hr>    \n    You have made a smart decision! 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PD ROH -->\n                                \n                                \n                                \n                                <!-- Conversant Media 728x90 LEADERBOARD CODE for AdRx - PD ROH -->     \n                                            <\/li>\n              <\/ul>\n            <\/div>\n          <\/div>\n        <\/div>\n          \n                \n        \n        <div id=\"content\">      \n        \n\n<div id=\"k2ModuleBox143\" class=\"k2ArchivesBlock\">\n  <div id=\"title\" style=\"font-size: 20px;color: #333333;font-family: Verdana !important;padding-left:11px;padding-top:20px\"><strong>Archives<\/strong><\/div>\n    \n       \n<\/div>\n        \n         \n<div id=\"system-message-container\">\n<\/div>\n        \n<!-- Start K2 Item Layout -->\n<span id=\"startOfPageId64\"><\/span>\n\n<div id=\"k2Container\" class=\"itemView\">\n\n\t<!-- Plugins: BeforeDisplay -->\n\t\n\t<!-- K2 Plugins: K2BeforeDisplay -->\n\t\n\t<div class=\"itemHeader\">\n\n\t\t\t\t<!-- Date created -->\n\t\t<span class=\"itemDateCreated\">\n\t\t\tWednesday, 31 August 2005 00:00\t\t<\/span>\n\t\t\n\t  \t  <!-- Item title -->\n\t  <h1 class=\"itemTitle\">\n\t\t\t\t\t\t\t\t\n\t\t\tFDA Issues Warning on Breast Cancer Drug\n\t\t\t\n\t  <\/h1>\n\t  \n\t\t\n  <\/div>\n\n  <!-- Plugins: AfterDisplayTitle -->\n  \n  <!-- K2 Plugins: K2AfterDisplayTitle -->\n  \n\t  <div class=\"itemToolbar\">\n\t\t<ul>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t<!-- Item Social Button -->\n\t\t\t<li>\n\t\t\t\t\n\n\n<!-- AddThis Button BEGIN -->\n<div class=\"addthis_toolbox addthis_default_style\" style=\"margin-top: 15px\">\n\n\n\n\n\n<\/div>\n<div style=\"position: absolute;margin-bottom: 1px;margin-top: -19px;margin-left: 164px\">\n\t\t\t\n\t\t\t&lt;div class=&quot;fb-like&quot; data-send=&quot;false&quot; data-layout=&quot;button_count&quot; data-width=&quot;200&quot; data-show-faces=&quot;true&quot; data-font=&quot;verdana&quot; \n<\/div>\n<div style=\"position: absolute;margin-bottom: 1px;margin-top: -20px;margin-left: 176px\">\nTweet\n<\/div>\n<\/div>\n\n<!-- AddThis Button END -->\n\n\n\n    \n\n\n\t\t\t<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\t\t\t<\/ul>\n\t\t<div class=\"clr\"><\/div>\n  <\/div>\n\t\n\t\n  <div class=\"itemBody\">\n\n\t  <!-- Plugins: BeforeDisplayContent -->\n\t  \n\t  <!-- K2 Plugins: K2BeforeDisplayContent -->\n\t  \n\t  \n\t  \t  <!-- Item text -->\n\t  <div class=\"itemFullText\">\n\t  \t<p>WEDNESDAY, Aug. 31 (HealthDay News) &#8212; Federal health authorities today issued a warning about the potential heart problems associated with use of the breast cancer drug Herceptin.<\/p>\n\n<p>While\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"vwnjxlzqyleavnnppg\"><\/span>\n\n experts had already known of the potential problems, the warning, along with a letter from Genentech, the drug&#8217;s maker, constitutes a more formal acknowledgement of the issue.<\/p>\n\n<p>&#8220;Herceptin\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"vwnjxlzqyleavnnppg\"><\/span>\n\n is known to have adverse effects on the heart in a certain number of patients. That information in itself is not new,&#8221; said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society in Atlanta. &#8220;I suspect that many oncologists who were using the drug were already aware of it, but it is still nonetheless important that this be put into some more formal language and process.&#8221; <\/p>\n\n<p>The U.S. Food and Drug Administration reported in their warning that in a randomized phase III trial, women taking Herceptin were at more than triple the risk of congestive heart failure and cardiac death than women receiving chemotherapy alone. The absolute numbers were still low, however, with 4.1 percent of women in the Herceptin arm experiencing heart problems versus only 0.8 percent in the other arm.<\/p>\n\n<p>The\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"vwnjxlzqyleavnnppg\"><\/span>\n\n FDA warning went on to say that there were no cardiac deaths in patients in the Herceptin-only arm, whereas there was one cardiac death in the control arm. This apparently means that most of the problems seen were congestive heart failure.<\/p>\n\n<p>Lichtenfeld\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"vwnjxlzqyleavnnppg\">student loan calculator<\/span>\n\n said it was unlikely that this news would change the status of Herceptin, which, in recent months, had been emerging as a major weapon in the fight against HER-2 positive breast cancers.  <\/p>\n\n<p>&#8220;This\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"vwnjxlzqyleavnnppg\">seo services<\/span>\n\n will do nothing to change people&#8217;s decisions about using the drug,&#8221; he said. &#8220;This is information that was readily available, and doctors are already aware of it.&#8221; <\/p>\n\n<p>HER-2 positive breast cancers produce too much of the HER-2 protein, which stands for human epidermal growth factor receptor 2 and is found on the surface of the cells. These tumors tend to grow faster and are more likely to recur than tumors that are HER-2 negative.  <\/p>\n\n<p>About 40,000 to 50,000 of the 200,000 women who develop breast cancer annually in the United States have HER-2 positive tumors. <\/p>\n\n<p>Herceptin was approved in 1998 to treat metastatic breast cancer. <\/p>\n\n<p>Earlier\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"vwnjxlzqyleavnnppg\"><\/span>\n\n this year, two trials of the drug in women with early-stage breast cancer showed such promising results that they were halted early.<\/p>\n\n<p> In these cases, patients with early stage HER-2 positive breast cancer who were given Herceptin in combination with chemotherapy had a 52 percent decrease in their risk for a recurrence compared with patients who received chemotherapy without the drug.<\/p>\n\n<p>Herceptin, also known as trastuzumab, is a targeted therapeutic antibody, meaning it has a specific mechanism of action, and is already approved for metastatic breast cancer. <\/p>\n\n<p>The current warning concerned women with early-stage breast cancer, meaning that the FDA is effectively issuing a warning on an off-label usage of a drug.<\/p>\n\n<p>No matter what the usage, experts pointed out, treatment decisions always need to involve weighing the risks and benefits.  <\/p>\n\n<p>&#8220;Everything is relative to the condition that you&#8217;re treating,&#8221; Lichtenfeld said. &#8220;This is a situation that can be life-threatening for a substantial number of women. The use of Herceptin in that situation reduces the chance of recurrence significantly. It&#8217;s also appropriate, given the degree of adverse heart-related events, that doctors make patients aware of the risks. Herceptin has a significant chance of reducing the risk of recurrence, but it does come at a cost.&#8221;<\/p>\n\n<p>&#8220;This\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"vwnjxlzqyleavnnppg\"><\/span>\n\n is a clarity issue, an acknowledgement that the extent of the problem was really nothing to be ignored. It&#8217;s not an inconsequential event, it&#8217;s not uncommon event for that matter,&#8221; added Dr. Stephen Mal\t  <\/p><\/div>\n\t  \n\t\t<div class=\"clr\"><\/div>\n\n\t  \n\t\t\n\t  <!-- Plugins: AfterDisplayContent -->\n\t  \n\t  <!-- K2 Plugins: K2AfterDisplayContent -->\n\t  \n\t  <div class=\"clr\"><\/div>\n  <\/div>\n\n\t\n  \n  \n  \n\t\t\t\n  \n\t<div class=\"clr\"><\/div>\n\n  \n  \n  \n  <!-- Plugins: AfterDisplay -->\n  \n  <!-- K2 Plugins: K2AfterDisplay -->\n  \n  \n \n\t\t<div class=\"itemBackToTop\">\n\t\t<a class=\"k2Anchor\" href=\"https:\/\/healthdailyusa.com\/index.php?page_id=1449#startOfPageId64\">\n\t\t\tback to top\t\t<\/a>\n\t<\/div>\n\t\n\t<div class=\"clr\"><\/div>\n<\/div>\n<!-- End K2 Item Layout -->\n\n<!-- JoomlaWorks \"K2\" (v2.5.4) | Learn more about K2 at http:\/\/getk2.org -->\n\n\n              \n                <div class=\"artBanner\">  \n            <div class=\"carouselbanner\">\n                <div id=\"wrap\">\n                    <ul id=\"mycarousel90\" class=\"jcarousel-skin-tango\">\n                        <li>\n                                                            <!-- Conversant Media 160x600 WIDE SKYSCRAPER CODE for AdRx - PD ROH -->\n                                \n                                \n                                \n                                <!-- Conversant Media 160x600 WIDE SKYSCRAPER CODE for AdRx - PD ROH -->\n                                                   \n                      <\/li>\n                    <\/ul>\n                <\/div>\n            <\/div>\n        <\/div>      \n          <\/div>\n        <div class=\"clr\"><\/div>    \n    \n       <div id=\"bottombar\">\n        <div class=\"panel\" style=\"float:none !important\">\n            <div class=\"bannergroup\">\n                <div class=\"banneritem\">\n                                        \t<!-- Conversant Media 300x250 Medium Rectangle CODE for AdRx - PD ROH -->\n\t\t\t\t\t\t\n                        \n                        \n                        <!-- Conversant Media 300x250 Medium Rectangle CODE for AdRx - PD ROH -->\n                                           \n                <\/div>\n            <\/div>\n        <\/div>                   \n        <div class=\"panel\" style=\"height:600px !important;margin-top:10px\">\n            <div class=\"bannergroup\">\n              <div class=\"banneritem\"> \n                                                               \n                                 \n                <\/div>\n            <\/div>\n        <\/div>\n  <\/div>\n        \n                     \n  <\/div>  \n  <div id=\"footer\">\n    <div class=\"copyright\">\t\n\n<div class=\"custom\">\n\t<p>\n\tCopyright \u00a9 2012 Healthdailyusa.com. \t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"vwnjxlzqyleavnnppg\"> companies<\/span>\n\n\nAll Rights Reserved.<\/p>\n<\/div>\n<\/div>\n    <div class=\"nav\">\t\n<ul class=\"menu\">\n<li class=\"item-323 current active\">Archives<\/li><li class=\"item-177\"><a href=\"https:\/\/healthdailyusa.com\/index.php?page_id=1130\">Sitemap<\/a><\/li><li class=\"item-179\"><a href=\"https:\/\/healthdailyusa.com\/index.php?page_id=442\" target=\"_blank\">Disclaimer<\/a><\/li><li class=\"item-181\"><a href=\"https:\/\/healthdailyusa.com\/index.php?page_id=962\" target=\"_blank\">Privacy Policy<\/a><\/li><li class=\"item-213\"><a href=\"https:\/\/healthdailyusa.com\/index.php?page_id=124\">About Us<\/a><\/li><li class=\"item-183\"><a href=\"https:\/\/healthdailyusa.com\/index.php?page_id=153\">Contact Us<\/a><\/li><\/ul>\n<\/div>\n    <div class=\"socialnetworking\">\n         \n        \n      <\/div>\n  <\/div>\n  <div id=\"bottom\"><\/div>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>Thank You! 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