The possibility that a federal judge in Texas could ban a common abortion pill has sparked a comparison of the drug’s safety profile versus popular erectile dysfunction drug Viagra.
U.S. District Judge Matthew Kacsmaryk, nominated to the court by former President Donald Trump in 2018 amid a controversy over his opposition to abortion and LGBTQ rights, is expected to rule soon on a lawsuit that could result in a ban on the drug mifepristone.
Rather than attempting to debate moral objections to abortion, the anti-abortion groups who filed the lawsuit claim that the Food and Drug Administration (FDA) “chose politics over science” and ignored safety concerns, particularly involving minors, when approving the drug.
Mifepristone was approved by the FDA over 22 years ago. It is often taken in conjunction with the drug misoprostol and used to induce an abortion during the first 10 weeks of pregnancy or to manage an early miscarriage.
Plaintiffs are asking Kacsmaryk to issue an injunction that would block sales of the drug across the country, including in states where abortion remains legal following last year’s Supreme Court reversal of Roe v. Wade.
The possibility of a ban on the drug has prompted many on social media to argue that misoprostol presents far fewer safety risks than Viagra.
“The abortion pill mifepristone is safer than Viagra,” tweeted the official Women’s March Twitter account. “No one’s trying to ban Viagra.”
The abortion pill mifepristone is safer than Viagra.
No one’s trying to ban Viagra.
— Women’s March (@womensmarch) February 28, 2023
“An important reminder about medication abortion: Mifepristone* is safer than Tylenol, Viagra, and penicillin,” the National Council of Jewish Women tweeted. “It is safer than childbirth. It’s been FDA approved for over 20 years. Attacks on medication abortion are driven only by ideology.”
An important reminder about medication abortion:
Mifepristone* is safer than Tylenol, Viagra, and penicillin.
It is safer than childbirth.
It’s been FDA approved for over 20 years.
Attacks on medication abortion are driven only by ideology.
*The med ruled on today
— National Council of Jewish Women (@NCJW) March 15, 2023
Some suggested that Viagra safety concerns should lead to it being banned, especially if access to abortion continues to be restricted.
“We can do this,” tweeted user @caroleknigin. “If Viagra may cause us unwanted pregnancies we cannot abort. Let’s BAN VIAGRA.”
We can do this. If Viagra may cause us unwanted pregnancies we cannot abort. Let’s BAN VIAGRA
— MAX (@caroleknigin) March 15, 2023
“One judge affecting millions of womens healthcare,” @CyaChristi tweeted. “For 23 years Mifepristone has proven track record for safety and efficacy. In fact, it’s safer than the little blue pill, VIAGRA. Let’s ban viagra.”
One judge affecting millions of womens healthcare. For 23 years Mifepristone has proven track record for safety and efficacy. In fact, it’s safer than the little blue pill, VIAGRA. Let’s ban viagra. pic.twitter.com/wEJEm8hp47
— cya Doctors/Vets For Democrats (@CyaChristi) March 15, 2023
The plaintiffs in the Texas suit say that the FDA rushed to approve mifepristone in 2000 by improperly using an expedited process, while also waiving a requirement to study its effects in minors separately.
Regardless of Kacsmaryk’s ultimate ruling, an appeal is likely to be filed in the 5th Circuit Court of Appeals, which features a majority of judges appointed by Republican presidents.
An amicus brief filed in support of the FDA from multiple major medical organizations argues that “hundreds of medical studies and vast amounts of data amassed over the course of two decades” have shown the drug is “exceedingly safe.”
“Serious side effects occur in less than 1% of patients, and major adverse events— significant infection, blood loss, or hospitalization—occur in less than 0.3% of patients,” the brief states. “The risk of death is almost non-existent.”
In fact, research conducted in the decades since mifepristone was approved does appear to confirm that the drug presents few serious safety concerns.
According to FDA data, out of an estimated 5.8 million times mifepristone was used from September 2020 to June 2022, there were 28 reports of deaths “associated with” the drug.
It is not clear how many, if any, of the deaths were actually caused by the drug. The deaths were also associated with other potential causes including methadone overdose, emphysema, suspected homicide and suicide.
The data also reveals that reports of any “adverse event” were exceedingly low among those who took mifepristone. A total of 4,213 events were reported—occurring in fewer than one out of every 1,300 cases.
In addition, a 2013 review of 87 different trials found that using mifepristone with misoprostol was “highly effective and safe.” A 2015 study concluded that medication-induced abortions were less likely to cause “major complications” than procedural abortions.
A 2001 study involving adolescents ages 14 to 17 who had abortions using mifepristone and misoprostol found that the drug was “highly effective and well tolerated,” with no complications seen among the 28 participants.
Meanwhile, a systematic review of deaths associated with Viagra that was published in December found that it was tied to many more adverse events, although they were still rare considering that millions of prescriptions are filled each year.
The review found that over 2,000 deaths were among the 26,451 adverse events associated with sildenafil, the generic name for Viagra, that were reported to the FDA over 10 years.
As with the abortion pill, it was not clear that the Viagra-associated deaths were caused by the drug itself.
Based on FDA data and decades of research, both mifepristone and Viagra appear to be largely safe when taken as prescribed and directed.
Regardless, as the data shows a significantly higher rate of adverse events and deaths associated with Viagra, the argument that mifepristone is safer appears to be sound.
Newsweek has reached out to the FDA for comment.
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