The Associated Press reported on October 19, 2011 an Oklahoma judge had temporarily blocked from taking effect a new law that requires health care providers to follow the strict guidelines and protocols for medical abortion as it was approved by the U.S. Food and Drug Administration in 2000.
Attorney Michelle Mohaved of the New York-based Center for Reproductive Rights, which is representing the plaintiffs said she was "thrilled" by the ruling as a victory for abortion rights advocates.
However, this is not a victory for the women that are being misinformed of the actual risks of the combined use of the two medical abortion inducing drugs known as mifepristone (RU486) and misoprostol that was approved by the FDA to terminate early pregnancy up to 7 weeks gestation.
These drugs are dangerous and should be used only in strict accordance with FDA guidelines.
Eight American women have died from sepsis (serious infection involving the bloodstream) following medical abortion with mifepristone and misoprostol. These women were instructed to follow various off-label abortion protocols using unapproved/modified regimens that were not recognized by the FDA as being safe and effective.
Four of these deaths included 18-year-old Holly Patterson, 21-year-old Hoa Thuy "Vivian" Tran, 22-year-old Chanelle Bryant, and 34-year-old Oriane Shevin who each tragically died from a toxic shock infection following medical abortion. These women were instructed by their providers to use an off-label medical abortion regimen that was not approved by the FDA.
Attorney Movahed has disputed the state of Oklahoma's assertion that abortion drugs caused the deaths of these women.
This statement is inaccurate.
According the FDA’s website: FDA has concluded these deaths may possibly be related to the use of these drugs. (1)
Movahed has gone on record and stated the following: “Those cases were investigated by both the FDA and the (Centers for Disease Control and Prevention) and there was absolutely no causal relationship found between those unfortunate deaths and the medications that had been used."
This statement is also inaccurate and misleading.
In 2004 and 2005 , following the death of Holly Patterson and three other young women, the FDA updated the black box warning on mifepristone, trade name Mifeprex, to warn against serious and sometimes fatal infections and bleeding that can occur following medical abortion. The boxed warning states that no causal relationship of these abortion inducing drugs and events have been established.
So how is Attorney Movahed misrepresenting the facts?
First, the FDA would not have placed a boxed warning on the mifepristone abortion drug if there was absolutely no causal relationship found between the women’s deaths and the drugs that were used to terminate early pregnancy.
Second, a drug’s labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established. (2)
I am no lawyer, but I can read and understand the facts.
The FDA does not need to establish a causal relationship. It is evident that women are dying from using abortion inducing drugs such as mifepristone and misoprostol. A black box warning, the highest level of possible warnings was added to mifepristone’s labeling at the direction of the FDA.
Finally, a number of so-called evidence-based, alternative, or off-label treatment drug variations have emerged as researchers study other medical abortion regimens that may prove simpler than the FDA-approved approach and may serve a larger number of patients.
This is a major health care concern for women because these unapproved off-label drug uses that circumvent the FDA approval process may have negative public health consequences — including exposing patients to unnecessary risks and destroying the incentive for drug companies to conduct the necessary research to demonstrate that products are safe and effective for these uses.
The FDA-approved medical abortion regimen, an oral combination of 600 mg mifepristone followed 2 days later by office-based administration of 400 mcg of misoprostol, has been used in only 4% of abortion provider facilities since its approval in 2000. (3)
The FDA has issued Public Health Advisories (2005, 2006) about sepsis following medical abortion along with a reminder to providers stating the importance of the approved regimen for medical abortion through 49 days’ pregnancy.
The author of the 2011 HB 1970 Oklahoma measure, Republican Rep. Randy Grau of Edmond, should be disappointed with the judge's decision.
It was the wrong decision. Oklahomans are not the only women at risk. This ruling sends a message to all women in the U.S. who are considering medical abortion that unapproved off-label dosing regimens are based on solid scientific evidence and advancements in medicine.
The FDA should not agree with the statements made by Attorney Movahed simply because off-label uses can have potentially negative consequences by undercutting expectations that drug safety and efficacy have been fully evaluated.
Many experts laud abortion inducing drugs as a "safe and effective" alternative to surgical abortion. Medical abortion is an unpredictable and dangerous alternative, especially when providers are not following the FDA approved protocol.
A woman making a medical abortion decision needs to understand the risks, benefits, and options available that is in her best interest of health, safety and welfare.
Women deserve to be told the truth and know the real facts and risks.
1. U.S. Department of Health & Human Services. Drugs, Mifeprex Questions and Answers, Question 18, What does FDA know about serious infections reported with Mifeprex use?, 2/24/2010. FDA, U.S. Food and Drug Administration. [Online] February 24, 2010. [Cited: October 21, 2011.]http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111328.htm
2. U.S. Department of Health & Human Services. CFR – Code of Federal Regulations, Labeling, Title 21, Volume 4, 21CFR201.57, (6) 5 Warnings and precautions . (i) General., FDA, U.S Food and Drug Administration. [Online] April 1, 2010. [Cited: October 21, 2011.]http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.57
3. Wiegerinck, Melanie MJ, et al., et al. Medical abortion practices: a survey of National Abortion Federation members in the United States, Contraception, Vol.78, Issue 6. pages 492-499. NCBI, PubMed. [Online] December 2008. http://www.ncbi.nlm.nih.gov/pubmed/19014795