{"id":22466,"date":"2023-03-30T11:46:56","date_gmt":"2023-03-30T18:46:56","guid":{"rendered":"https:\/\/ameripharmaspecialty.com\/?p=22466"},"modified":"2026-03-19T14:41:03","modified_gmt":"2026-03-19T21:41:03","slug":"makena-reducing-the-risk-of-premature-births","status":"publish","type":"post","link":"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/","title":{"rendered":"Makena: Reducci\u00f3n del riesgo de nacimientos prematuros"},"content":{"rendered":"\n<p><span style=\"font-weight: 400;\">Makena is the brand name of an injection that contains the active drug hydroxyprogesterone caproate. Hydroxyprogesterone is an artificial progesterone-like hormone in a class of drugs called <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK563211\/#:~:text=Progestins%2C%20or%20progestogens%2C%20are%20a,class%20or%20their%20structural%20derivation.\">progestins<\/a>.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Makena is indicated for use to reduce the risk of premature birth in pregnant women.&nbsp; Premature birth is when the baby arrives early before the scheduled due date, usually before 37 weeks of pregnancy. Premature birth has a higher prevalence in women who have had a previous premature birth.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Makena is only available with a doctor\u2019s prescription. Makena is not intended for women with multiple pregnancies (twins or triplets). Likewise, Makena will not help if premature labor has already started.&nbsp;<\/span><\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#How_Is_Makena_Supplied_and_Used\" >How Is Makena Supplied and Used?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#How_Does_Makena_Work\" >How Does Makena Work?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#What_Are_the_Side_Effects_of_Makena\" >What Are the Side Effects of Makena?<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#Common_Side_Effects\" >Common Side Effects<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#Serious_Side_Effects\" >Serious Side Effects<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#Other_Side_Effects\" >Other Side Effects<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#Postmarketing_Experience\" >Postmarketing Experience<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#Can_Makena_Harm_an_Unborn_Baby\" >Can Makena Harm an Unborn Baby?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#Makena_Dosage\" >Makena Dosage<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#What_Should_You_Know_Before_Taking_Makena\" >What Should You Know Before Taking Makena?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#How_Much_Does_Makena_Cost\" >How Much Does Makena Cost?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#Is_a_Generic_Version_Available\" >Is a Generic Version Available?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/ameripharmaspecialty.com\/es\/discontinued\/makena-reducing-the-risk-of-premature-births\/#Is_Makena_Still_FDA_Approved\" >Is Makena Still FDA Approved?<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"How_Is_Makena_Supplied_and_Used\"><\/span>How Is Makena Supplied and Used?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">Makena comes in the following forms and strengths:<\/span><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\">1.1 ml single-use auto-injector containing 275 mg of hydroxyprogesterone caproate for subcutaneous (SC) use. A healthcare provider injects the drug into the area beneath the skin, usually in the back of your upper arm.&nbsp;<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">1 ml single-dose vial for intramuscular (IM) injection containing 250 mg of active drug.<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">5 ml multi-dose vial for IM administration containing 1,250 mg of active drug.<\/span><\/li>\n<\/ol>\n\n\n\n<p><span style=\"font-weight: 400;\">A healthcare professional will inject Makena subcutaneously or intramuscularly based on the dosage. The IM formulation is usually injected into the buttock muscle.<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"How_Does_Makena_Work\"><\/span>How Does Makena Work?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">It is understood that Makena and its active ingredient, which is hydroxyprogesterone caproate, <\/span><span style=\"font-weight: 400;\">help to get the pregnancy to full term in women pregnant with one baby and those who have had a previous premature birth.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">According to <a href=\"https:\/\/www.amagpharma.com\/\">the manufacturer<\/a>, a lower proportion of Makena-treated women delivered before 37 weeks compared to those who received a placebo.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Researchers believe that progesterone supplementation may help prevent preterm birth by [1]:&nbsp;<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\">Altering hormones and other substances that regulate uterine contraction and the timing of labor.&nbsp;<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Reducing inflammation and premature rupture of the membranes.&nbsp;<\/span><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_Are_the_Side_Effects_of_Makena\"><\/span>What Are the Side Effects of Makena?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Common_Side_Effects\"><\/span><span style=\"font-weight: 400;\">Common Side Effects<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"alignright\"><img loading=\"lazy\" decoding=\"async\" width=\"420\" height=\"280\" src=\"https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/woman-with-nausea.jpg\" alt=\"Pregnant woman with nausea\" class=\"wp-image-22474\" srcset=\"https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/woman-with-nausea.jpg 420w, https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/woman-with-nausea-300x200.jpg 300w, https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/woman-with-nausea-330x220.jpg 330w, https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/woman-with-nausea-86x57.jpg 86w, https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/woman-with-nausea-167x111.jpg 167w, https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/woman-with-nausea-280x187.jpg 280w, https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/woman-with-nausea-370x247.jpg 370w\" sizes=\"auto, (max-width: 420px) 100vw, 420px\" \/><\/figure>\n<\/div>\n\n\n<p><span style=\"font-weight: 400;\">While side effects are rare, the most common side effects of the injection include:&nbsp;<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\">Pain, swelling, itching, and irritation at the injection site<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Nausea<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Diarrhea<\/span><\/li>\n<\/ul>\n\n\n\n<p><span style=\"font-weight: 400;\">These effects typically go away without any specific treatment. However, if they persist or worsen, talk to your doctor immediately.&nbsp;<\/span><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Serious_Side_Effects\"><\/span><span style=\"font-weight: 400;\">Serious Side Effects<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">Makena may cause severe side effects, such as:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\">Blood clots. Common symptoms include leg swelling, pain, and redness.&nbsp;<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Depression<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Headaches<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Jaundice (yellowish skin and eyes)<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">High blood pressure&nbsp;<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Allergic reactions, which may cause hives, itching, swelling of the face, and breathing difficulty&nbsp;<\/span><\/li>\n<\/ul>\n\n\n\n<p><span style=\"font-weight: 400;\">Talk with your doctor immediately if you experience any of the symptoms above during treatment.&nbsp;<\/span><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Other_Side_Effects\"><\/span><span style=\"font-weight: 400;\">Other Side Effects<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">In clinical trials, Makena use was associated with a higher occurrence of the following conditions:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\">Miscarriage (pregnancy loss before the 20th week)<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Stillbirth (fetal death during or after the 20th week)<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Hospital admission for preterm labor<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.preeclampsia.org\/\">Preeclampsia<\/a> (high blood pressure and elevated protein levels in the urine)<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Gestational hypertension (high blood pressure during pregnancy)&nbsp;<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Gestational diabetes (diabetes first diagnosed during pregnancy)<\/span><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Postmarketing_Experience\"><\/span><span style=\"font-weight: 400;\">Postmarketing Experience<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">Once a medicine reaches the market following approval, users may voluntarily report side effects to the manufacturer or the FDA. This practice is known as postmarketing surveillance (PMS).&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Users have reported the following adverse effects:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\">Fever<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Hot flashes<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Flushes<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Vomiting<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Urinary tract infection<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Headache<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Dizziness<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Premature rupture of membranes<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Weak cervical tissues<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Shortened cervix<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Shortness of breath<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Chest discomfort<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Skin rashes<\/span><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Can_Makena_Harm_an_Unborn_Baby\"><\/span>Can Makena Harm an Unborn Baby?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">Only a few studies have looked into the effects of Makena on an unborn baby (fetus). For instance, one infant follow-up study failed to find evidence of fetal abnormalities in infants born to pregnant women who used Makena. Likewise, animal studies have found no evidence of harm to the mother or fetus.&nbsp;&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Makena_Dosage\"><\/span>Makena Dosage<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><b>Subcutaneous (SC) route<\/b><span style=\"font-weight: 400;\">: 275 mg (1.1 ml) once weekly using auto-injector.&nbsp;<\/span><\/p>\n\n\n\n<p><b>Intramuscular (IM) route<\/b><span style=\"font-weight: 400;\">: 250 mg (1 ml) once weekly.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Treatment begins between the 16th and 20th week of gestation and is continued until the 37th week of gestation or delivery (whichever occurs first).<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_Should_You_Know_Before_Taking_Makena\"><\/span>What Should You Know Before Taking Makena?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">You should not start Makena if you have:&nbsp;<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\">An allergy to hydroxyprogesterone or castor oil<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Abnormal vaginal bleeding unrelated to your pregnancy<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Severe or uncontrolled high blood pressure<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Liver disease or liver cancer<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Jaundice associated with pregnancy<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">A history of cancer of the breast, uterus\/cervix, or vagina<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">A history of a stroke, blood clot, or circulatory system diseases<\/span><\/li>\n<\/ul>\n\n\n\n<p><span style=\"font-weight: 400;\">The US FDA has not approved Makena for use in individuals younger than 16 years old.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Your doctor should know if you have a history of:<\/span><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><span style=\"font-weight: 400;\">Preeclampsia<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Kidney disease<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">High blood pressure<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Heart disease<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Migraine&nbsp;<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Diabetes&nbsp;<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Seizures<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Asthma<\/span><\/li>\n\n\n\n<li><span style=\"font-weight: 400;\">Depression<\/span><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"How_Much_Does_Makena_Cost\"><\/span>How Much Does Makena Cost?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">The cost of treatment may vary depending on your insurance plan, geographical location, and pharmacy. Contact your insurance provider to find out if your plan covers Makena or if you need prior authorization.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">The manufacturer offers financial assistance of up to $5,000 or until therapy is complete. Click <\/span><a href=\"https:\/\/ameripharmaspecialty.com\/financial-assistance\/\"><span style=\"font-weight: 400;\">here<\/span><\/a><span style=\"font-weight: 400;\"> to learn more.&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Is_a_Generic_Version_Available\"><\/span>Is a Generic Version Available?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">Yes. You can get generic versions of Makena. Talk to your doctor, pharmacist, or other healthcare professionals for more information.&nbsp;<\/span><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Is_Makena_Still_FDA_Approved\"><\/span>Is Makena Still FDA Approved?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><span style=\"font-weight: 400;\">Yes, Makena is still approved in the United States.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">However, a federal advisory panel has been seeking to revoke the medicine\u2019s approval since 2020, citing that its effectiveness remains doubtful.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">The <a href=\"https:\/\/www.fda.gov\/\">FDA<\/a> granted Makena an accelerated approval in 2011 after a small trial showed the drug to be beneficial [2]. Nonetheless, the drug failed to replicate the benefits in a large 2019 study [3].&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Following the controversial findings, the FDA\u2019s Obstetrics, Reproductive and Urologic Drugs Advisory Committee reviewed the available evidence and voted on whether the drug should remain on the market. The vote was 14-1 against the drug\u2019s effectiveness.<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">The panel members fear that keeping an apparently \u201cineffective\u201d medicine in the market may expose women to potentially life-threatening risks, such as blood clots, allergic reactions, and depression.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">On the other hand, the maker of Makena stresses that since Makena is the only FDA-approved drug in the U.S. to prevent preterm births, revoking its approval may lead to unwanted consequences.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">Furthermore, the maker has proposed to the panel to continue approval while they conduct another trial to demonstrate the drug\u2019s effectiveness. Likewise, they have also proposed a partial withdrawal, meaning only women at the highest risk of premature birth will have access to the drug.&nbsp;<\/span><\/p>\n\n\n\n<p><span style=\"font-weight: 400;\">It remains to be seen whether the drug will stay on the market.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Makena es el nombre comercial de una inyecci\u00f3n que contiene el principio activo caproato de hidroxiprogesterona. La hidroxiprogesterona es una hormona artificial similar a la progesterona, perteneciente a la clase de f\u00e1rmacos denominados progest\u00e1genos. Makena est\u00e1 indicado para reducir el riesgo de parto prematuro en mujeres embarazadas.\u00a0<\/p>","protected":false},"author":13,"featured_media":22467,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":true,"om_disable_all_campaigns":false,"_uag_custom_page_level_css":"","footnotes":""},"categories":[64],"tags":[17],"class_list":["post-22466","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-discontinued","tag-dr-saba-rassouli"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Makena: Reducing the Risk of Premature Births<\/title>\n<meta name=\"description\" content=\"Learn about the drug, Makena. 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En su tiempo libre, le gusta pasear, leer y probar diferentes restaurantes y comidas.","url":"https:\/\/ameripharmaspecialty.com\/es\/author\/saba-rassouli\/"}]}},"uagb_featured_image_src":{"full":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman.jpg",1280,853,false],"thumbnail":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-150x150.jpg",150,150,true],"medium":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-300x200.jpg",300,200,true],"medium_large":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-768x512.jpg",768,512,true],"large":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-1024x682.jpg",1024,682,true],"1536x1536":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman.jpg",1280,853,false],"2048x2048":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman.jpg",1280,853,false],"trp-custom-language-flag":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman.jpg",18,12,false],"block-image-html-large":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman.jpg",600,400,false],"ct-gallery":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-330x220.jpg",330,220,true],"ct-section-header":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-1146x380.jpg",1146,380,true],"ct-thumb":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-86x57.jpg",86,57,true],"ct-thumb-large":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-167x111.jpg",167,111,true],"ct-small":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-280x187.jpg",280,187,true],"ct-medium":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-370x247.jpg",370,247,true],"ct-xmedium":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman-960x640.jpg",960,640,true],"ct-large":["https:\/\/ameripharmaspecialty.com\/wp-content\/uploads\/2023\/03\/pregnant-woman.jpg",1280,853,false]},"uagb_author_info":{"display_name":"Dr. Saba Rassouli, PharmD","author_link":"https:\/\/ameripharmaspecialty.com\/es\/author\/saba-rassouli\/"},"uagb_comment_info":0,"uagb_excerpt":"Makena is the brand name of an injection that contains the active drug hydroxyprogesterone caproate. 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Hydroxyprogesterone is an artificial progesterone-like hormone in a class of drugs called progestins.\u00a0Makena is indicated for use to reduce the risk of premature birth in pregnant women.\u00a0","_links":{"self":[{"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/posts\/22466","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/comments?post=22466"}],"version-history":[{"count":0,"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/posts\/22466\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/media\/22467"}],"wp:attachment":[{"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/media?parent=22466"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/categories?post=22466"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ameripharmaspecialty.com\/es\/wp-json\/wp\/v2\/tags?post=22466"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}