{"id":198403,"date":"2019-03-14T18:50:37","date_gmt":"2019-03-14T23:50:37","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=198403"},"modified":"2019-03-13T17:50:30","modified_gmt":"2019-03-13T22:50:30","slug":"fda-warns-websites-abortion-pills-illegally","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-warns-websites-abortion-pills-illegally\/","title":{"rendered":"FDA warns websites to stop selling abortion pills illegally"},"content":{"rendered":"
<\/div>

(Life Site News<\/a>)\u00a0The U.S. Food and Drug Administration (FDA) on Tuesday released two letters it sent last Friday to a pair of websites offering unapproved versions of the abortion-inducing drugs mifepristone and misoprostol.<\/p>\n

The letters to Aidaccess.org<\/a> and Rablon<\/a> note that the sites sell mifepristone and misoprostol tablets in \u201cpacks\u201d that can be acquired without a prescription and taken without a medical professional\u2019s guidance or supervision. In \u201cnormal\u201d chemical abortions, abortionists give women the first pill (mifepristone, or RU-486) in an office, then have them take the second (misoprostol) at home.<\/p>\n

By contrast, these sites each offer a product that \u201ccontains prescription drugs intended for a condition that is not amenable to self-diagnosis and treatment by a layperson,\u201d the letters warn, so \u201cadequate directions cannot be written such that a layperson can use the product safely for its intended use.\u201d In addition, they lack \u201cadequate warnings against use…where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application.\u201d<\/p>\n

Even the FDA-approved prescription version of mifepristone, Mifeprex, \u201cbears a boxed warning indicating that the drug carries a risk of serious or even life-threatening adverse effects, including serious and sometimes fatal infections and prolonged heavy bleeding,\u201d and is therefore \u201conly available in the U.S. through a Risk Evaluation and Mitigation Strategy (REMS) program\u201d and obtainable only from REMS-certified healthcare providers.<\/p>\n

READ:\u00a0Abortion pill reversal and abortion waiting periods save lives<\/a><\/em><\/strong><\/p>\n

The REMS requirements ensure that providers can \u201cassess the duration of the pregnancy accurately, diagnose ectopic pregnancies, and provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made arrangements for others to provide such care\u201d; give women \u201caccess to medical facilities for emergency care\u201d; and more \u2013 none of which applies to Aidaccess.org\u2019s \u201cCombipack\u201d or Rablon\u2019s \u201cAbortion Pill Pack.\u201d<\/p>\n

\u201cBy facilitating the sale of the unapproved and misbranded\u201d products, the FDA says, these sites are \u201ccausing important safety measures that are put in place for FDA-approved mifepristone for medical termination of early pregnancy to be bypassed.\u201d<\/p>\n