{"id":353334,"date":"2016-04-04T10:46:51","date_gmt":"2016-04-04T15:46:51","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/prempro-frequently-asked-questions.html"},"modified":"2024-01-22T14:25:21","modified_gmt":"2024-01-22T19:25:21","slug":"prempro-frequently-asked-questions","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/prempro-frequently-asked-questions.html","title":{"rendered":"Prempro Legal Information"},"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\">Prempro Legal Information<\/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                            January 22, 2024\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        <p>Prempro has been linked to serious health risks, including breast cancer, stroke, and heart disease, prompting thousands of lawsuits against its manufacturer, Pfizer. Courts have held that drug manufacturers may be liable if they fail to adequately warn patients and physicians about known dangers.<\/p>\n\n    <\/div>\n\n\n\n<p>Prempro, approved by the U.S. Food and Drug Administration (FDA) in 1995, is a drug that treats symptoms of menopause and osteoporosis.<\/p>\n<p>Prempro is also known as conjugated estrogen\/medroxyprogesterone acetate. It&#8217;s a combination of two hormones \u2014\u00a0<a href=\"http:\/\/www.nlm.nih.gov\/medlineplus\/druginfo\/meds\/a601041.html\" target=\"_blank\" rel=\"noopener\">estrogen and progestin<\/a>. Prempro was the first estrogen\/progestin combination drug available for hormone replacement therapy (HRT). It&#8217;s still one of the most common HRTs doctors prescribe today.<\/p>\n<p>This article explains how Prempro works and its associated health risks. You&#8217;ll also find important FDA actions regarding the drug, and how to file a legal claim if you&#8217;ve been harmed by Prempro or another medication.<\/p>\n<p>You can also talk to a <a href=\"https:\/\/lawyers.findlaw.com\/products-liability-law\/?\" target=\"_blank\" rel=\"noopener\">product liability attorney<\/a> for legal advice specific to your situation. An attorney can review your case and determine if you have a valid claim. Pharmaceutical companies have specialized in-house attorneys to defend against lawsuits. If you decide to go up against them, you&#8217;ll want expert legal help on your side, too.<\/p>\n<h2>What Is Prempro?<\/h2>\n<p><a href=\"https:\/\/www.webmd.com\/drugs\/2\/drug-5365\/prempro-oral\/details\" target=\"_blank\" rel=\"noopener\">Prempro<\/a>\u00a0contains two hormones \u2014 estrogen and progestin. Healthcare professionals prescribe it to postmenopausal women who have not had a hysterectomy. They also prescribe this FDA-approved medication to women who have endometriosis.<\/p>\n<p>Regarding osteoporosis, remember that no medication <a href=\"https:\/\/www.webmd.com\/vitamins-and-supplements\/calcium\" target=\"_blank\" rel=\"noopener\">can replace calcium<\/a>. Your doctor can determine whether this drug is an effective treatment for you. They will discuss whether it is contraindicated in your situation.<\/p>\n<p>Prempro helps with the following:<\/p>\n<ul>\n<li>Reducing hot flashes<\/li>\n<li>Treating vaginal dryness<\/li>\n<li>Alleviating itching and burning<\/li>\n<li>Decreasing vasomotor symptoms<\/li>\n<li>Reducing chances of getting\u00a0<a href=\"https:\/\/www.mayoclinic.org\/diseases-conditions\/osteoporosis\/symptoms-causes\/syc-20351968\" target=\"_blank\" rel=\"noopener\">osteoporosis<\/a><\/li>\n<\/ul>\n<p>According to clinical trials, progestin also reduces the risk of endometrial cancer in women.<\/p>\n<h2>Should Postmenopausal Women Take Estrogen Alone or Estrogen Plus Progestin?<\/h2>\n<p>Pfizer, the manufacturer of Prempro and\u00a0<a href=\"https:\/\/www.webmd.com\/drugs\/2\/drug-5364\/premphase-oral\/details\" target=\"_blank\" rel=\"noopener\">Premphase<\/a>, suggests that these medications are for postmenopausal women suffering from vasomotor symptoms. Check with your doctor if you&#8217;re taking some form of estrogen, either alone or in combination with progestin.<\/p>\n<p>There are different doses and types of Prempro. For example,\u00a0<a href=\"https:\/\/labeling.pfizer.com\/showlabeling.aspx?id=133&amp;section=PPI\" target=\"_blank\" rel=\"noopener\">Prempro 0.3<\/a>\u00a0contains calcium, magnesium, and other chemicals. You may not want to overload your body with too many hormones. Your doctor can help determine the best plan for you.<\/p>\n<h2>Prempro Side Effects<\/h2>\n<p>Like most other drugs, there are several side effects of Prempro. Some of these are minor. Others may be a sign of a more significant problem, like blood clots. If you experience any of these adverse side effects or experience an allergic reaction, see your doctor immediately.<\/p>\n<p>Common side effects of Prempro include:<\/p>\n<ul>\n<li>Irregular periods<\/li>\n<li>Breast pain and tenderness<\/li>\n<li>Angioedema and swelling<\/li>\n<li>Headaches<\/li>\n<li>Vaginitis<\/li>\n<li>Endometrial hyperplasia<\/li>\n<\/ul>\n<p>Before you start Prempro, you must tell your doctor about any supplements and medications you&#8217;re taking.<\/p>\n<p>It&#8217;s also essential that you ask about taking this drug if you&#8217;re pregnant or breastfeeding. There&#8217;s a chance that these medications can affect your breast milk.<\/p>\n<p>You should also avoid certain things while taking Prempro, such as <a href=\"https:\/\/www.webmd.com\/hypertension-high-blood-pressure\/grapefruit-juice-and-medication\" target=\"_blank\" rel=\"noopener\">grapefruit<\/a>. If you experience a missed dose of Prempro, consult your doctor. You don&#8217;t want to take too much of any medication without your physician&#8217;s advice.<\/p>\n<h2>Serious Health Risks Associated With Prempro<\/h2>\n<p>In 1991, the National Heart, Lung, and Blood Institute (NHLBI) began a long-term study of ways to prevent heart disease, breast and colorectal cancer, and osteoporosis in women. This\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3963523\/\" target=\"_blank\" rel=\"noopener\">Women&#8217;s Health Initiative<\/a>\u00a0(WHI) consists of clinical and observational studies involving more than 161,000 healthy, postmenopausal women.<\/p>\n<p>One of the studies involved 16,608 women. Some took Prempro, while others took a placebo. This study aimed to see if Prempro helps prevent heart disease and hip fractures. Researchers cut the Prempro part of that study short three years early because researchers determined the risks of Prempro outweighed its benefits.<\/p>\n<p>These risks included but were not limited to the following:<\/p>\n<ul>\n<li>Breast cancer<\/li>\n<li>Stroke<\/li>\n<li>Heart disease<\/li>\n<li>High blood pressure<\/li>\n<li>Cancer of the uterus or ovaries<\/li>\n<li>Blood clots<\/li>\n<li>Shortness of breath<\/li>\n<\/ul>\n<p>A separate study also confirmed that taking Prempro increased the risk of seizures in postmenopausal <a href=\"https:\/\/www.epilepsy.com\/stories\/female-hormone-replacement-therapy-may-increase-seizure-frequency\" target=\"_blank\" rel=\"noopener\">women with epilepsy<\/a>. Experts also warn women with a thyroid disorder to avoid taking Prempro.<\/p>\n<h2>Early FDA Action Regarding Prempro<\/h2>\n<p>In 2003, the FDA announced that it had approved\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2009\/020527s046lbl.pdf\" target=\"_blank\" rel=\"noopener\">new labels for Prempro<\/a>. This new label included a new boxed warning to emphasize Pempro patients&#8217; increased risk of several disorders, including:<\/p>\n<ul>\n<li>Heart disease<\/li>\n<li>Heart attacks<\/li>\n<li>Strokes<\/li>\n<li>Breast cancer<\/li>\n<\/ul>\n<p>Besides incorporating the WHI findings, the updated labels would state that Prempro isn&#8217;t for preventing coronary heart disease. The labels would also say to take Prempro no longer than necessary. Doctors should periodically reevaluate your prescription.<\/p>\n<p>These new warnings also advised that women should only take Prempro to prevent osteoporosis or to treat vaginal dryness and irritation. There are alternative, non-hormonal treatments that carry less risk.<\/p>\n<p>The FDA also indicated that all manufacturers of estrogen and estrogen-progestin products should add <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/warnings-and-precautions-contraindications-and-boxed-warning-sections-labeling-human-prescription\" target=\"_blank\" rel=\"noopener\">similar warnings<\/a> to labels and patient information leaflets.<\/p>\n<h2>Can You Sue the Manufacturers of Prempro?<\/h2>\n<p>Talking to a <a href=\"https:\/\/lawyers.findlaw.com\/personal-injury-plaintiff\/\" target=\"_blank\" rel=\"noopener\">personal injury lawyer<\/a> is the best way to determine if you have a valid claim against Pfizer. A qualified attorney can analyze the details of your case.<\/p>\n<p>To date, Pfizer has paid more than $1 billion to settle legal claims. They have also litigated more than 10,000 lawsuits. In 2011 alone, the company settled claims for more than\u00a0<a href=\"https:\/\/www.fiercepharma.com\/pharma\/pfizer-to-pay-330m-prempro-settlement\" target=\"_blank\" rel=\"noopener\">$300 million<\/a>.<\/p>\n<p>This doesn&#8217;t mean you have a legitimate claim for damages. It depends on several factors, including how long you took the drug and the extent of your injuries.<\/p>\n<p><a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/product-liability-legal-help.html\">Meet with an attorney<\/a> to determine your best course of action.<\/p>\n<h2>If Prempro Harmed You, Legal Help Is Available<\/h2>\n<p>Almost all medications have some anticipated side effects. Drug manufacturers must adequately inform physicians about any known risks with their drugs. If a manufacturer fails to do so, it may be liable for patients&#8217; injuries.<\/p>\n<p>If you or a loved one has taken Prempro and experienced any unusual side effects or suffered injury, contact a physician for medical attention. Then, contact an attorney\u00a0who can assess your legal rights and help you get\u00a0<a href=\"https:\/\/www.findlaw.com\/injury\/accident-injury-law\/economic-recovery-for-accidents-and-injuries.html\">compensation for any injuries<\/a>.<\/p>\n<p>FindLaw&#8217;s directory of <a href=\"https:\/\/www.findlaw.com\/injury\/product-liability\/get-legal-help-with-a-defective-product-injury.html?fli=dcta\">products 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 drug and medical device litigation. Many law offices 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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class=\"was-this-helpful__feedback-form-title\" tabindex=\"0\">Why was this not helpful?<\/legend>\n                    <div class=\"was-this-helpful__choose-option-message\" role=\"status\">\n                        <p class=\"was-this-helpful__choose-option-message-text\"><\/p>\n                    <\/div>\n                    <div class=\"fl-radio-button-field fl-flex was-this-helpful__feedback-form-title\">\n                        <input\n                                id=\"was-this-helpful__radio-button--missing-info\"\n                                class=\"fl-radio-button-field-input\"\n                                type=\"radio\"\n                                name=\"negative-feedback\"\n                                value=\"Missing Information\"\n                        >\n                        <label\n                                class=\"fl-radio-button-field-label fl-text-sm was-this-helpful__radio-label\"\n                                for=\"was-this-helpful__radio-button--missing-info\"\n                        >Missing the information I need<\/label>\n                    <\/div>\n                    <div class=\"fl-radio-button-field fl-flex was-this-helpful__feedback-form-title\">\n                        <input\n                                id=\"was-this-helpful__radio-button--complicated\"\n                                class=\"fl-radio-button-field-input\"\n                                type=\"radio\"\n                                name=\"negative-feedback\"\n                                value=\"Too complicated\"\n                        >\n                        <label\n                                class=\"fl-radio-button-field-label fl-text-sm was-this-helpful__radio-label\"\n                                for=\"was-this-helpful__radio-button--complicated\"\n                        >Too complicated \/ too many steps<\/label>\n                    <\/div>\n                    <div 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     class=\"fl-radio-button-field-input\"\n                                type=\"radio\"\n                                name=\"negative-feedback\"\n                                value=\"Other\"\n                        >\n                        <label\n                                class=\"fl-radio-button-field-label fl-text-sm was-this-helpful__radio-label\"\n                                for=\"was-this-helpful__radio-button--negative-other\"\n                        >Other<\/label>\n                    <\/div>\n                <\/fieldset>\n            <\/div>\n            <div class=\"was-this-helpful__form-buttons-container\">\n                <button\n                    class=\"was-this-helpful__feedback-button was-this-helpful__feedback-button--positive at-feedback-submit fl-button secondary\"\n                    type=\"submit\"\n                >\n                    <span class=\"fl-button-content\">Submit<\/span>\n                    <i\n                        class=\"fa fa-angle-right medium\"\n                        aria-hidden=\"true\"\n                    ><\/i>\n                <\/button>\n                <button\n                    class=\"was-this-helpful__feedback-button was-this-helpful__feedback-button--cancel fl-button primary disabled\"\n                    type=\"reset\"\n                >\n                    <span class=\"fl-button-content\">Cancel<\/span>\n                    <i\n                        class=\"fa fa-times-circle medium\"\n                        aria-hidden=\"true\"\n                    ><\/i>\n                <\/button>\n            <\/div>\n        <\/form>\n    <\/div>\n    <div class=\"was-this-helpful__thank-you-message\" role=\"status\">\n        <i class=\"was-this-helpful__thank-you-message-icon fa fa-check\"><\/i>\n        <p class=\"was-this-helpful__thank-you-message-text\" aria-live=\"polite\"><\/p>\n    <\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"fl-section-sidebar\"><div class=\"fl-editors-summary\" data-testid=\"fl-editors-summary\">\n    \n    <div class=\"fl-editors-summary-content\" data-testid=\"fl-editors-summary-content\">\n                    <h2>Can I Solve This on My Own or Do I Need an Attorney?<\/h2>\n                <div class=\"fl-editors-summary-content-main\" data-testid=\"fl-editors-summary-content-main\">\n            \n        <\/div>\n        <ul class=\"fl-list-style-none\">\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    A lawyer can help seek fair compensation on your behalf\n\n                <\/li>\n                            <li data-testid=\"fl-editors-summary-content-item\">\n                    <i class=\"fa fa-check medium fl-editors-summary-content-item-icon\" aria-hidden=\"true\"><\/i>\n                    Drug manufacturers have teams of lawyers on 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