The abortion pill at the center of a landmark lawsuit has a stronger safety profile than commonly used drugs like Viagra and Tylenol, data shows.
Mifepristone, sold under the name Mifeprex, was pulled from shelves last week by a U.S. district court in Texas, citing concerns about the drug’s safety.
Plaintiffs’ main argument was that the Food and Drug Administration (FDA) had not properly established its safety prior to its approval in 2000.
But in the 23 years since mifepristone — half of a two-tablet abortion treatment — a total of one in 200,000 users has died from complications of the drug.
Mifepristone causes deaths in 0.5 in every 100,000 people taking the drug. The figure pales in comparison to the number of Tylenol and Viagra users who die as a result of the side effects of the medication. According to official data, 0.8 per 100,000 Tylenol users and 4.9 per 100,000 Viagra users will die
About 48.9 per 100,000 mifepristone users experience side effects from the drugs, compared to 93.3 per 100,000 Tylenol users and 59.4 per 100,000 Viagra users
Compared to other commonly used drugs, mifepristone proves to be one of the safest behind-the-counter pharmacy pills.
According to an analysis of FDA data from the State of Ohio and the University of Virginia4.9 out of every 100,000 users of the class of drugs that Viagra belongs to suffer fatal complications – nearly ten times that of mifepristone.
Also, 59.4 out of every 100,000 experience some side effect.
Viagra works by loosening blood vessels and increasing circulation throughout the body.
While almost always safe, its effects on circulation can, in rare cases, cause a heart attack or irregular heartbeat.
Acetaminophen, known as Tylenol, is one of the most popular medications in America, but it comes with its own risk factors.
While safe in small doses, long-term use of the medicine cabinet staple can cause toxins to build up in the liver. Since it is available over the counter, there are no regulations on how much someone takes at a time.
In the most severe cases, it can cause fatal liver failure.
According to a report from the Desert Regional Medical Centerthe drug is responsible for 500 deaths and 56,000 hospital visits annually due to side effects.
This suggests that out of 60 million regular users, 0.8 in 100,000 will die and 93.3 in 100,000 will seek treatment for a side effect.
Both numbers overshadow the reported safety concerns for mifepristone.
According to official data from the June 2022 Food and Drug Administration (FDA), 5.6 million women had used mifepristone since it became available in September 2000.
Among that group, 28 women were determined to have died of complications from taking the drug.
Also included in the dataset were 2,740 women who had an adverse event of any kind, including 768 who required hospitalization to manage these issues.
The drug works by blocking the body’s secretion of the hormone progesterone. This, in turn, leads to the breakdown of the uterine lining and terminates the pregnancy.
Known side effects include nausea, weakness, fever, vomiting and headache.
In many cases, a woman will then use the ulcer drug misoprostol, which causes the body to eject the terminated fetus through heavy vaginal bleeding.
Potentially dangerous side effects were at the center of a case brought to court by the Alliance for Hippocratic Medicine, a conservative anti-abortion group.
The plaintiffs argued that, as doctors, they had seen many patients seeking treatment after being prescribed the abortion medication.
They also cited studies revealing mifepristone’s known side effects.
Government attorneys representing the FDA and the Department of Justice (DoJ) argue that this data was considered when the agency approved the drug in 2000.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ruled that the drug’s approval should be frozen Friday.
He said in his decision, “The Court does not lightly question the FDA’s decision.
“But here the FDA conceded its legitimate safety concerns — in violation of its legal duty — based on frankly flawed reasoning and studies that didn’t support its conclusions.”
Mifepristone’s approval was not controversial based on trial data, and the drug has continued to demonstrate its safety and effectiveness in its 22 years of use.
Mifepristone first received FDA approval in 2000, in the time since 5.6 million women have used it to induce an abortion (file photo)
The federal government and pro-choice groups in the US quickly condemned Judge’s decision based on these safety concerns.
The Justice Department immediately announced plans to appeal the ruling, saying on Friday: “The Justice Department strongly disagrees with the decision of the District Court…Friday.
“Today’s decision reverses the FDA’s expert judgment, made more than two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision.
“The Department is committed to protecting Americans’ access to legal reproductive care.”
An appeal was lodged on Monday.
Dr. Heminia Palacio, president and CEO of The Guttmacher Institute, a nonprofit organization that fights for abortion rights across America, wrote to DailyMail.com: “Judge Kacsmaryk’s decision seeking to revoke mifepristone’s decades-long FDA approval flies into the face of overwhelming scientific evidence.
It is critical to note that the decision will not take effect for at least a week after it was first pronounced on April 7.
“The facts are clear: Mifepristone is safe and effective, has undergone a lengthy and rigorous review by the FDA, has been used more than four million times since it was first approved in 2000, and is so widely accepted by patients and healthcare providers that it now accounts for more than half of all abortions in the US.”
It is still legal to prescribe and deliver mifepristone, at least until Friday, when the week-long stay that Judge Kacsmaryk ordered to give the government time to appeal ends ends.
Pharmacies certified to dispense the pills can still do so until then.
The FDA, the Department of Justice and Danco Laboratories, the pill’s manufacturer, have appealed to the 5th Circuit Court.
If the appeals court does not grant emergency aid to at least one of them, the drug will be removed from the shelves on Friday.