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Mifepristone: US judge halts approval for abortion pill Mifepristone: US judge halts approval for abortion pill
(32 minutes later)
A Texas judge has revoked the longstanding approval for the widely used abortion drug mifepristone.A Texas judge has revoked the longstanding approval for the widely used abortion drug mifepristone.
The pill has been authorised for over 20 years, and is used in more than half of US pregnancy terminations.The pill has been authorised for over 20 years, and is used in more than half of US pregnancy terminations.
In a 67-page opinion, Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, suspended his own ruling for seven days to allow the government time to appeal.In a 67-page opinion, Judge Matthew Kacsmaryk, an appointee of former President Donald Trump, suspended his own ruling for seven days to allow the government time to appeal.
His decision could limit access to the drug for millions of women.His decision could limit access to the drug for millions of women.
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A lawsuit filed by an anti-abortion group in Texas, the Alliance Defending Freedom, argued that the drug's safety was never properly studied.A lawsuit filed by an anti-abortion group in Texas, the Alliance Defending Freedom, argued that the drug's safety was never properly studied.
'Barbaric' abortion law nearly killed these Texas women
'Barbaric' abortion law nearly killed these Texas women
In his ruling, Judge Kacsmaryk said the Food and Drug Administration (FDA) approval of the drug back in 2000 had violated federal rules that allow for accelerated approval of certain drugs.In his ruling, Judge Kacsmaryk said the Food and Drug Administration (FDA) approval of the drug back in 2000 had violated federal rules that allow for accelerated approval of certain drugs.
The FDA spent four years reviewing mifepristone before it was approved in 2000.The FDA spent four years reviewing mifepristone before it was approved in 2000.
The decision could further restrict access to abortion nationwide since the US Supreme Court removed constitutional protections for the procedure last year, triggering a wave of state-by-state bans.The decision could further restrict access to abortion nationwide since the US Supreme Court removed constitutional protections for the procedure last year, triggering a wave of state-by-state bans.
This breaking news story is being updated and more details will be published shortly. Please refresh the page for the fullest version. Legal analysts said the ruling threatened to upend the entire foundation of America's drug regulatory system.
You can receive Breaking News on a smartphone or tablet via the BBC News App. You can also follow @BBCBreaking on Twitter to get the latest alerts. How safe is the abortion pill mifepristone?
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Mifepristone, part of a two-drug regimen that induces abortions, effectively stops the pregnancy, while the second drug, misoprostol, empties the uterus.
It was first approved for the termination of pregnancy up until seven weeks gestation.
In 2016, its approved use was extended to 10 weeks of pregnancy.
Mifepristone is also used to treat women who have suffered miscarriages and Cushing syndrome, a hormone-related condition.
The FDA, the American College of Obstetrics and Gynaecologists (ACOG) and other mainstream medical organisations say both mifepristone and misoprostol are safe for use.
The FDA has reported a total of 26 deaths associated with the drug since it was approved - a rate of about 0.65 deaths per 100,000 by-pill abortions.
For comparison, the death rate associated with habitual aspirin use is about 15.3 deaths per 100,000 aspirin users.
Related Topics
Abortion
Texas
US politics
United States