Abortion pill that could be banned across US has lower risk of side effects than Tylenol, Viagra

The abortion pill at the center of a landmark court case has a stronger safety profile than commonly used drugs such as Viagra and Tylenol, data shows.

Mifepristone, sold under the name Mifeprex, was pulled from shelves by a US District Court Judge in Texas last week, citing safety concerns with the drug.

The main argument from plaintiffs was that the Food and Drug Administration (FDA) did not properly establish its safety before its 2000 approval. 

But in the 23 years since mifepristone – one-half of a two-tablet abortion treatment – a total of one per every 200,000 users have died from complications from the drug.

Mifepristone causes deaths in 0.5 per every 100,000 people who use the drug. The figure pales to the number of users of Tylenol and Viagra that die because of the medication’s side effects. According to official data, 0.8 per every 100,000 Tylenol users and 4.9 per every 100,000 Viagra users will die

Around 48.9 per every 100,000 mifepristone users experience adverse effects to the drugs, compared to 93.3 per 100,000 Tylenol users and 59.4 per every 100,000 Viagra users

When stacked up against other common drugs, mifepristone proves itself to be one of the safest pills behind the pharmacy counter.

According to an analysis of FDA data from Ohio State and the University of Virginia, 4.9 of every 100,000 users of the class of drugs that includes Viagra suffer deadly complications — nearly ten-fold that of mifepristone.

Also, 59.4 of every 100,000 suffer an adverse event of some sort. 

Viagra works by loosening blood vessels and increasing circulation across the body.

While almost always safe, its effects on the circulatory system can cause a heart attack or irregular heartbeat in rare cases. 

Acetaminophen, known as Tylenol, is one of the most popular drugs in America but famously comes with its own risk factors.

While safe in small doses, long-term use of the medicine cabinet staple can cause toxins to gather in the liver. Because it can be purchased over the counter, there is no regulation on how much a person takes at a time.

In the most serious of cases, it can cause deadly liver failure.

According to a Desert Regional Medical Center report, the drug is responsible for 500 deaths and 56,000 hospital visits caused by adverse events each year.

This suggests that out of 60 million regular users, 0.8 per 100,000 will die and 93.3 per 100,000 will seek treatment for an adverse event.

Both of these figures eclipse the safety risks reported for mifepristone. 

According to official Food and Drug Administration (FDA) data from June 2022, 5.6million women had used mifepristone since it became available in September 2000.

Among that group, 28 women were determined to have died from complications using the drug. 

Also included in the data set was 2,740 women who suffered an adverse event of any type, including 768 who required hospitalization to treat these issues.

The drug works by blocking the body’s secretion of the hormone progesterone. This, in turn, leads to a breaking down of the uterus lining and terminates the pregnancy.

Known side effects include nausea, weakness, fever, vomiting and headaches, among others. 

In many cases, a woman will use the stomach ulcer drug misoprostol afterward, 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 they, as doctors, had seen many patients seek treatment after receiving the medication abortion.

They also cited studies that highlighted the known side effects of mifepristone.

Government lawyers representing the FDA and Department of Justice  (DoJ) argue that this data was considered when the agency approved the drug in 2000.

US District Judge Matthew Kacsmaryk, a Trump appointee, ruled for the drug’s approval to be frozen on Friday.

He said in his decision: ‘The Court does not second-guess FDA’s decision-making lightly.

‘But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.’

Mifepristone’s approval was not controversial based on trial data, and the drug has continued to show its safety and efficacy in the 22 years it has been used.

Mifepristone first received FDA approval in 2000, in the time since 5.6million women have used it to induce an abortion (file photo)

The Federal Government and pro-choice groups across the US swiftly condemned the decision by Judge based on these safety concerns.

The DoJ immediately announced plans to appeal the ruling, saying Friday: ‘The Justice Department strongly disagrees with the decision of the District Court… and will be appealing the court’s decision and seeking a stay pending appeal,’ the agency wrote after the ruling Friday.

‘Today’s decision overturns the FDA’s expert judgment, rendered over 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 filed Monday. 

Dr Heminia Palacio, president and CEO of The Guttmacher Institute, a non-profit that fights for abortion rights across America, wrote to DailyMail.com: ‘The decision handed down by Judge Kacsmaryk that attempts to revoke the decades-long FDA approval of mifepristone flies in the face of overwhelming scientific evidence. 

‘It’s critical to note that the decision will not go into effect for at least a week after it was first handed down on April 7.

‘The facts are clear: Mifepristone is safe and effective, underwent lengthy and rigorous review by the FDA, has been used well over four million times since it was first approved in 2000, and has become so widely accepted by patients and providers that it now accounts for more than half of all US abortions.’

It is still legal to prescribe and dispense mifepristone at least until Friday when the week-long stay that Judge Kacsmaryk imposed to give the government time to appeal expires.

Pharmacies certified to dispense the pills can still do so until then.

The FDA, Department of Justice, and Danco Laboratories, the manufacturer of the pill, have filed appeals to the 5th Circuit Court.

If the appeals court does not grant at least one of them emergency relief, then the drug will be pulled from shelves on Friday.