15th December, 2016
The U.S. FDA (Food and Drug Administration) approved updated labeling for Mifepristone which is an abortion pill, by its brand name Mifeprex on March 29, 2016. Mifepristone is usually prescribed along with another medication named Misoprostol to complete the medical pregnancy termination in the U.S. The decision of FDA towards changing the label is important in many ways. Even though off-label drugs are normally accepted in the United States, several clinicians, or pharmacies make out FDA labels as guides to appropriate and legally defendable clinical practice. Primarily, the label update reaffirms that termination of pregnancy through medication is very safe and highly effective. It also has the potential to increase access to medical abortion in the country.
An update based on Evidence and Clinical Practice:
Number of studies of alternate medication pregnancy cancellation regimens has been conducted by several scientists and medical providers since before Mifeprex was approved in 2000. Ever since it has been approved, many healthcare professionals have prescribed Mifeprex according to the procedure in the updated label, so the label has been proven safe and effective and is now aligned with standard medical practice. Although changes have been made in the labeling and gestational period but there is no change in the Mifepristone cost. In United States, the medicine has been used in more than 2.75 million pregnancy terminations, since last 15 years. The serious complications found are extremely rare.
One of the most important benefits to the Mifepristone label is an increase in eligibility from 7 weeks to 10 weeks of gestation. The change demonstrates that it is safe and effective to use Mifepristone/Misoprostol regimen to use within 10 week of gestation through substantial evidence. This change has considerable implications for access to end pregnancy through medicines, like before just 37% of all U.S. abortions were suitable for mifepristone, as per the original protocol, but the percentage has now risen up to 75% as a result of the updated protocol. Most women prefer to buy Mifepristone online as a convenient source of terminating pregnancy at home.
Improving Access to Medical Abortion:
In addition to increase in the eligibility of pregnancy termination through medication, the Mifepristone label update will likely support an existing trend of purchasing Mifepristone online and towards early abortion. According to CDC’s data, the time period of pregnancy cancellation has shifted to earlier in the first trimester since a decade because of the increasing availability of medical abortion. Moreover, even though the overall number of terminations in the United States has been declining since 1990s, there has been a reasonable growth of about 6% in the share of pregnancy terminations performed using abortion pills in 2001 (one year after the approval of Mifepristone) to 23% share in 2011 (the most recent available data).