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Mifeprex News

FDA Eases Restrictions on Abortion Medication

Posted 31 Mar 2016 by Drugs.com

WEDNESDAY, March 30, 2016 – The U.S. Food and Drug Administration is making it easier for women to obtain a medication that induces abortion. Under changes announced Wednesday by the agency, women in most states who want the drug, called mifepristone (Mifeprex), will need to make just two trips to a doctor, instead of three. They'll also have 10 weeks from the start of their last period to use the medication to terminate pregnancy, up from the prior cutoff of 49 days, The New York Times reported. Additionally, the FDA is reducing the drug's dosage from 600 milligrams to 200 mg, reportedly reducing the cost of mifepristone and its potential side effects. Abortion-rights advocates welcomed the label changes. "Unlike state and federal anti-choice laws that restrict a woman's access to an abortion, the FDA decision to make mifepristone available to more women in this country is based on ... Read more

Related support groups: Abortion, Mifepristone, Mifeprex, Korlym

Korlym Approved for Cushing's Syndrome

Posted 20 Feb 2012 by Drugs.com

MONDAY, Feb. 20 – Korlym (mifepristone) has been approved by the U.S. Food and Drug Administration to treat endogenous Cushing's syndrome, a disabling disorder caused by overproduction of the so-called "stress hormone," cortisol. Cortisol is produced by the adrenal glands and increases blood sugar, making it particularly dangerous for people with diabetes. Korlym does not decrease production of the hormone, but reduces the effects of overproduction, the FDA said in a news release. The approval is for people with endogenous (of internal cause) Cushing's syndrome who have type 2 diabetes and who either haven't responded to previous surgery or aren't candidates for new surgery. Only about 5,000 people in the United States are likely to be eligible for the drug, the agency said. The medication was evaluated in clinical studies involving 50 people. Participants who took Korlym had ... Read more

Related support groups: Cushing's Syndrome, Mifepristone, Mifeprex

FDA Medwatch Alert: Mifeprex (mifepristone)

Posted 17 Mar 2006 by Drugs.com

[Posted 03/17/2006] The FDA notified healthcare professionals of two additional deaths following medical abortion with mifepristone (Mifeprex).  The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death. However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment. In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation. [March 17, 2006 (UPDATE April 10, 2006) - Drug Information Page – FDA] Read more

Related support groups: Mifeprex

FDA Medwatch Alert: Mifeprex (mifepristone)

Posted 19 Jul 2005 by Drugs.com

[Posted 07/19/2005] Danco Laboratories and FDA have revised the BOXED WARNING and WARNINGS sections of the Prescribing Information, the Medication Guide and Patient Agreement to inform healthcare professionals of four cases of septic deaths in the United States, all reported from California, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection. All providers of medical abortion and their patients need to be aware of the risks of sepsis.[July 19, 2005 - Public Health Advisory - FDA][July 19, 2005 - Drug Information Page - FDA][July 19, 2005 - Questions and Answers - FDA][July 19, 2005 - Letter - Danco Laboratories][July 19, 2005 ... Read more

Related support groups: Mifeprex

FDA Medwatch Alert: Mifeprex (mifepristone)

Posted 15 Nov 2004 by Drugs.com

Danco Laboratories and FDA notified healthcare professionals of revisions to the BOXED WARNING and WARNINGS sections, the MEDICATION GUIDE and PATIENT AGREEMENT of the Prescribing Information to describe serious and sometimes fatal infections and bleeding that may occur following the use of Mifeprex.[November 15, 2004 - Drug Information Page - FDA] Read more

Related support groups: Mifeprex

FDA Medwatch Alert: Mifeprex (mifepristone)

Posted 17 Apr 2002 by Drugs.com

The following is new safety information about Mifeprex (mifepristone):[April 17, 2002 Letter - Danco][April 17, 2002 Q&A - FDA] Read more

Related support groups: Mifeprex

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Mifeprex Patient Information at Drugs.com