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Additional Deaths Prompt New FDA Advisory Concerning RU-486 (Mifeprex)

Mar 18, 2006 | Newsinferno News Staff

Although the Food and Drug Administration remains reluctant to definitively link the drug mifepristone (Mifeprex) with a growing number of deaths following its use, there is little chance of the link being nothing more than a coincidence.

With the revelation that Danco Laboratories has informed the agency “of two additional deaths following medical abortions with mifepristone,” the agency has issued its third Advisory in the past 8 months (July 19, 2005 – November 4, 2005 - March 17, 2006) with respect to the possibility that women taking the drug may be exposed to potentially life-threatening infections.

Over a period of four years, there have been over 607 serious adverse events associated with the so-called “abortion pill” RU-486 reported to the FDA. These now include seven deaths, 68 cases of severe bleeding that required transfusions, and 66 cases of infection.
RU-486 was approved in the U.S. by the FDA in September of 2000, for the termination of early pregnancies. Since then, almost 500,000 doses have been administered.

The 607 complaints (a number that has certainly risen) were reported between September 2000 and September 2004. Of these, there were 237 cases of hemorrhage reported, with one resulting in death; 42 were determined to be life-threatening.

Of the reported cases of infection, there were seven incidences of septic shock ( when an infection enters the blood stream and endangers major organs) two of which ended in death.

Seventeen of the reported complications occurred because women had an undiagnosed ectopic pregnancy when they took the drug. Ectopic pregnancy occurs when the fertilized egg is implanted in an area outside the uterus, and can be deadly. Eleven cases resulted in ruptures and one in death.

Diagnosis of the potentially deadly compilcations of RU-486 is often delayed by the fact that the initial warning signs of serious illness, like abdominal cramping, nausea and vomiting are also frequent side effects of the drug itself.

The report of the hazardous complications incited a protest by the ant-abortion faction to remove the drug from the market. Researcher Dr. Margaret M. Gary, remarked to WebMD that  in her opinion the instances reported to the FDA make up only a fraction of the true medical problems that actually occur among RU-486 users. (The FDA has estimated that under-reporting can range as high as 90% to 99%).

Dr. Gary and co-author, Dr. Donna J. Harrison, are members of the American Association of Pro Life Obstetricians and Gynecologists, a group that advocates removal of RU-486 from the market.

In contrast, Harvard Medical School obstetrics and gynecology professor, Dr. Michael F. Greene, argued that underreporting of  complications may be less of a concern with RU-486 than with many other drugs because of the controversy surrounding it.

Dr. Greene says based on the current research it is difficult to determine whether RU-486 is safe or not. He says it is not clear if the drug is more dangerous than miscarriage or surgical abortion, or whether the deaths and other reported adverse events were caused by the drug. "I don't have a dog in this fight. But I do believe very strongly that women should have access to safe pregnancy termination rather than being forced to undergo unsafe pregnancy termination. If the safest way of terminating a pregnancy turns out to be surgical, then so be it. But until we have more compelling data, no one should leap to conclusions."

In November, considerable attention was focused on Mifeprex because of multiplte deaths among users of the drug from the same deadly bacteria, Clostridium sordellii, which is a rare and lethal bacterium for which there is no known cure once an infection takes hold.

At that time, the FDA as well as the Centers for Disease Control and Prevention (CDC) announced their intention to launch investigations into the possible link.

Mifeprex (RU-486), as an abortion pill, has been shrouded in controversy since 1996 when the federal advisory committee that recommended its approval was forced to meet under the protection of federal marshals.

Until last year, no one had ever suggested or suspected that the drug and the infection might be linked in some way. With the confirmation that at least five women had died from Clostridium sordellii infections within days of taking the drug, however, medical experts were faced with far more than a coincidence. It had turned into a public safety issue that required a satisfactorily explanation.

Since four of the five deaths occurred in a cluster between September 2003 and May 2005 in California, there was speculation that contamination may have played a role in the fatal infections. Testing by the FDA, however, proved negative for any such contamination.

As a result, the decision was been made to convene a special “public workshop” on May 11, 2006 at which officials from the FDA, the Centers for Disease Control and Prevention (CDC), and the National Institute of Allergy and Infectious Diseases (NIAID) will examine what has become a perplexing medical mystery. No doubt, the death, which occurred in Canada during clinical testing of the drug in 2001, will now be reexamined.

In each of the five previous deaths, Clostridium sordellii infected the woman's uterus, flourished, and then entered their bloodstreams. Death occurred in each case within one week of taking the drug.

This deadly bacterium can cause nausea, vomiting, diarrhea, and weakness. Since fever may not occur, however, victims often succumb to toxic shock without ever realizing how sick they really were. Once the infection has flourished, antibiotics are often ineffective because even in death, the bacteria continue to release deadly toxins.

Many experts are concerned about these revelations for a number of reasons. One is that other similar deaths may be going unreported because the association between the drug and the infection has not been made. A second is the under-reporting issue discussed above.

A third is that some researchers believe the drug itself impairs the immune system and makes patients more vulnerable to infection with Clostridium sordellii. Dr. James McGregor, of the University of Southern California, discussed that theory earlier this year in two medical publications.

As a result, critics of the drug are again calling for its removal from the market pending the outcome of the combined FDA and CDC probe.

Warnings about the drug's possible link with Clostridium sordellii were placed on Mifeprex's label in July, and the FDA updated this information on its Web site on November 4, without announcement, after it discovered that all four California deaths involved the Clostridium sordellii bacterium.

Although the FDA has stressed that the latest deaths reported by Danco have not been shown to have been “caused by sepsis” or, “if they were, if they were caused by infection with Clostridium sordellii,” the seriousness of the current Advisory is obvious.

As a public service, we are presenting (below) relevant excerpts from that FDA Advisory:

“Sepsis and Medical Abortion Update”

March 17, 2006

The Food and Drug Administration has been informed 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.

The approved Mifeprex regimen for a medical abortion through 49 days’ pregnancy is:

  • Day One: Mifeprex Administration: 3 tablets of 200 mg of Mifeprex orally at once
  • Day Three: Misoprostol Administration: 2 tablets of 200 mcg of misoprostol orally at once. 
  • Day 14: Post-Treatment: the patient must return to confirm that a complete termination has occurred. If not, surgical termination is recommended to manage medical abortion treatment failures. 
  • The safety and effectiveness of other Mifeprex dosing regimens, including use of oral misoprostol tablets intravaginally, has not been established by the FDA.

These recommendations are consistent with warnings in the Prescribing Information and information for the patient in the Medication Guide.  FDA also emphasizes that healthcare professionals and patients should be aware of the following:

  • All providers of medical abortion and emergency room health care providers should investigate the possibility of sepsis in patients who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain, and without fever or other signs of infection more than 24 hours after taking misoprostol. To help identify those patients with hidden infection, strong consideration should be given to obtaining a complete blood count.
  • FDA recommends that physicians suspect infection in patients with this presentation and consider immediately initiating treatment with antibiotics that includes coverage of anaerobic bacteria such as Clostridium sordellii.
  • FDA does not have sufficient information to recommend the use of prophylactic antibiotics. Reports of fatal sepsis in women undergoing medical abortion are very rare (approximately 1 in 100,000). Prophylactic antibiotic use carries its own risk of serious adverse events such as severe or fatal allergic reactions. Also, prophylactic use of antibiotics can stimulate the growth of “superbugs,” bacteria resistant to everyday antibiotics. Finally, it is not known which antibiotic and regimen (what dose and for how long) will be effective in cases such as the ones that have occurred.

As previously provided in our July 19, 2005 Public Health Advisory, updated on November 4, 2005, the Agency is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone (Mifeprex) and misoprostol.  All four cases of fatal infection tested positive for Clostridium sordellii.  

All four cases involved the off-label dosing regimen consisting of 200 mg of oral Mifeprex followed by 800 mcg of intra-vaginally placed misoprostol.  In addition, FDA tested drug from manufacturing lots of mifepristone and misoprostol and found no contamination with Clostridium sordellii.   

We do not know whether these new deaths were caused by sepsis or, if they were, if they were caused by infection with Clostridium sordellii. However, FDA, in conjunction with the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), is conducting a public workshop on May 11, 2006. This scientific workshop entitled, “Emerging Clostridial Disease,” at the CDC Conference Center, Atlanta, Georgia, is being conducted to discuss the scientific and medical circumstances associated with reports of morbidity and mortality associated with C. sordellii and C difficile infections. 

These reports include cases and clusters of C. sordellii toxic shock syndrome following treatment with mifepristone, C. sordellii sepsis associated with skin grafts, and rapidly fatal toxin-mediated cases of community-associated C. difficile infection.  The primary goal of the workshop is to bring together scientific and public health experts to develop a draft research agenda leading to a better understanding of the virulence, pathogenesis, host factors, and non-antimicrobial risk factors contributing to those reports.    

Mifeprex information can be found at:
http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm

Information pertaining to Emerging Clostridial Diseases Public Workshop can be found at   http://www.fda.gov/cder/meeting/clostridia_disease.htm


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