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| What is the abortion pill mifepristone and is it safe? | What is the abortion pill mifepristone and is it safe? |
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| Anti-abortion activists have moved to restrict access to abortion medication mifepristone | Anti-abortion activists have moved to restrict access to abortion medication mifepristone |
| Abortion pills are now the most common method of ending a pregnancy in the US, accounting for more than half of all abortions in the country. | Abortion pills are now the most common method of ending a pregnancy in the US, accounting for more than half of all abortions in the country. |
| They have also become the new frontier in the US battle over abortion access. | They have also become the new frontier in the US battle over abortion access. |
| Much of the fight is focused on mifepristone, one half of the two-pill regimen that makes up the safest and most effective mode of medication abortion. | Much of the fight is focused on mifepristone, one half of the two-pill regimen that makes up the safest and most effective mode of medication abortion. |
| Now, a lawsuit in Texas threatens to pull the drug off shelves nationwide. | Now, a lawsuit in Texas threatens to pull the drug off shelves nationwide. |
| Here is a look at mifepristone, what it does and where it is used. | |
| What is mifepristone? | What is mifepristone? |
| Mifepristone is the first of the two-pill regimen recommended by the Food and Drug Administration (FDA) to end a pregnancy. | Mifepristone is the first of the two-pill regimen recommended by the Food and Drug Administration (FDA) to end a pregnancy. |
| It works by blocking a hormone called progesterone, which is necessary for a pregnancy to continue. The second drug, misoprostol, empties the uterus. US studies say the two-step medication regime is effective 95% of the time. | It works by blocking a hormone called progesterone, which is necessary for a pregnancy to continue. The second drug, misoprostol, empties the uterus. US studies say the two-step medication regime is effective 95% of the time. |
| The US first approved mifepristone for the medical termination of pregnancy through seven weeks gestation in September 2000. In 2016, its approved use was extended to 10 weeks of pregnancy. | The US first approved mifepristone for the medical termination of pregnancy through seven weeks gestation in September 2000. In 2016, its approved use was extended to 10 weeks of pregnancy. |
| Mifepristone has been authorised for use in the US for two decades. | Mifepristone has been authorised for use in the US for two decades. |
| Misoprostol has been available by prescription for decades as a treatment for stomach ulcers and to manage postpartum haemorrhaging. Its non-pregnancy related uses are likely why it has not attracted the same controversy as mifepristone. | Misoprostol has been available by prescription for decades as a treatment for stomach ulcers and to manage postpartum haemorrhaging. Its non-pregnancy related uses are likely why it has not attracted the same controversy as mifepristone. |
| Meanwhile mifepristone is also used to treat women who have suffered miscarriages and Cushing syndrome, a hormone-related condition. | |
| According to the FDA, over 3.7 million women used mifepristone in the US between 2000 and 2018. | According to the FDA, over 3.7 million women used mifepristone in the US between 2000 and 2018. |
| Is mifepristone safe? | Is mifepristone safe? |
| For over 20 years of use, the FDA, the American College of Obstetrics and Gynaecologists (ACOG) and other mainstream medical organisations have maintained that both mifepristone and misoprostol are safe for use. | For over 20 years of use, the FDA, the American College of Obstetrics and Gynaecologists (ACOG) and other mainstream medical organisations have maintained that both mifepristone and misoprostol are safe for use. |
| US studies say the two-step medication regime is about 95% effective in ending pregnancy and requires further medical follow-up less than 1% of the time. | US studies say the two-step medication regime is about 95% effective in ending pregnancy and requires further medical follow-up less than 1% of the time. |
| Increasingly, anti-abortion campaigners have said that abortion medication, which they call "chemical abortion", is risky and ineffective. However, their claims are not supported by leading medical organisations, such as the World Health Organisation and the American Medical Association. | Increasingly, anti-abortion campaigners have said that abortion medication, which they call "chemical abortion", is risky and ineffective. However, their claims are not supported by leading medical organisations, such as the World Health Organisation and the American Medical Association. |
| According to the FDA, there are five deaths per million users of mifepristone. In comparison, a 2001 study in the Journal of the American Medical Association found there were about 20 deaths per million users of penicillin, due to an allergic reaction to the commonly prescribed antibiotic. | According to the FDA, there are five deaths per million users of mifepristone. In comparison, a 2001 study in the Journal of the American Medical Association found there were about 20 deaths per million users of penicillin, due to an allergic reaction to the commonly prescribed antibiotic. |
| Who is challenging access? | Who is challenging access? |
| Texas Judge Matthew Kacsmaryk revoked the FDA's 2000 approval of the drug in a controversial ruling earlier this month. | Texas Judge Matthew Kacsmaryk revoked the FDA's 2000 approval of the drug in a controversial ruling earlier this month. |
| The case was brought to his court by groups representing anti-abortion doctors and health professionals, who claimed the FDA erred by fast-tracking its approval process, and that it did not adequately consider the safety risks. | The case was brought to his court by groups representing anti-abortion doctors and health professionals, who claimed the FDA erred by fast-tracking its approval process, and that it did not adequately consider the safety risks. |
| The FDA says the process was not rushed, and that it took four years and reviewed many studies with tens of thousands of participants before approving the abortion pill. The FDA did use a part of US drug regulations that was designed to help "fast-track" approval processes, but it says it only used that provision to add further restrictions for safety reasons, such as requiring women to be assessed for the risk of ectopic pregnancies. | The FDA says the process was not rushed, and that it took four years and reviewed many studies with tens of thousands of participants before approving the abortion pill. The FDA did use a part of US drug regulations that was designed to help "fast-track" approval processes, but it says it only used that provision to add further restrictions for safety reasons, such as requiring women to be assessed for the risk of ectopic pregnancies. |
| In his ruling, Judge Kacsmaryk also said women could not give informed consent to taking mifepristone because the FDA had stopped recording any serious side effects that weren't fatal after 2016. He said this means women did not have all the information they needed to make their decision. | In his ruling, Judge Kacsmaryk also said women could not give informed consent to taking mifepristone because the FDA had stopped recording any serious side effects that weren't fatal after 2016. He said this means women did not have all the information they needed to make their decision. |
| The FDA says it only changed its reporting requirements after gathering data on all complications from 2000 to 2016, which suggested medication abortion carried a very low risk of serious complications. | The FDA says it only changed its reporting requirements after gathering data on all complications from 2000 to 2016, which suggested medication abortion carried a very low risk of serious complications. |
| Judge Kacsmaryk also made several claims about the mental health consequences of medication abortions, including that women "often experience shame, regret, anxiety [and] depression". These claims aren't supported by larger, more scientific studies which have found no link between choosing to have an abortion and experiencing poorer mental health. | Judge Kacsmaryk also made several claims about the mental health consequences of medication abortions, including that women "often experience shame, regret, anxiety [and] depression". These claims aren't supported by larger, more scientific studies which have found no link between choosing to have an abortion and experiencing poorer mental health. |
| Where is it available? | Where is it available? |
| Mifepristone and misoprostol are, for now, widely available in states where abortion is legal. | Mifepristone and misoprostol are, for now, widely available in states where abortion is legal. |
| The drugs' availability was expanded in April 2021, when the FDA said it would lift the in-person dispensing requirement for mifepristone for the duration of the Covid-19 pandemic. In December of last year, the FDA permanently lifted that requirement, meaning the medication was allowed to be sent by mail. | The drugs' availability was expanded in April 2021, when the FDA said it would lift the in-person dispensing requirement for mifepristone for the duration of the Covid-19 pandemic. In December of last year, the FDA permanently lifted that requirement, meaning the medication was allowed to be sent by mail. |
| The decision was applauded by pro-choice advocates. And to some, abortion pills delivered by mail were seen as a workaround for the abortion bans that swept the country after the reversal of Roe v Wade last June. | The decision was applauded by pro-choice advocates. And to some, abortion pills delivered by mail were seen as a workaround for the abortion bans that swept the country after the reversal of Roe v Wade last June. |
| US fight escalates over abortion pill at pharmacies | US fight escalates over abortion pill at pharmacies |
| Abortion pills a new front in culture wars | Abortion pills a new front in culture wars |
| Access was further expanded this year by another FDA change, which allowed retail pharmacies to dispense out the drug. Previously, only health-care providers were permitted to give out the drug. | Access was further expanded this year by another FDA change, which allowed retail pharmacies to dispense out the drug. Previously, only health-care providers were permitted to give out the drug. |
| What questions do you have on the issues in this story? Get in touch. | What questions do you have on the issues in this story? Get in touch. |
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| Related Topics | Related Topics |
| Abortion | Abortion |
| US abortion debate | US abortion debate |
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