FDA Concerned About Providers Offering Abortion Drugs Before Pregnancy | Health

Although health care providers are not allowed to offer a medical abortion before a patient becomes pregnant, some do, a spokesperson for the US Food and Drug Administration said. says Politico.

The FDA fears the practice is dangerous.

Medical abortion, also known as medical abortion, is a method in which a person terminates their pregnancy by taking two pills, rather than undergoing surgery. The first pill is mifepristone, sold under the brand names Mifeprex (formerly RU 486) or Korlym. The second pill is misoprostol.

Medical abortion now accounts for more than half of all abortions in the United States, according to the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health.

When mifepristone has been approved by the FDA in 2000, its use was restricted only to terminate a pregnancy 10 weeks or less after the first day of the person’s last menstrual period.

The FDA told Politico it is concerned that providers who administered medication for an abortion before becoming pregnant may not be able to properly oversee their patient’s care, including telling how far along she is. pregnancy or whether it is inside the uterus (intrauterine) or outside the uterus (ectopic).

The labeling of mifepristone indicates that it should not be used in case of ectopic pregnancy. The FDA did not have a direct response to the report when CNN asked for comment.

“They don’t recognize people’s ability to understand their own bodies and know what’s right for them,” said Ushma Upadhyay, a professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco Bixby Center for Global Reproductive Health.

The FDA’s concern over supplier oversight is not based on evidence, Upadhyay said. Some studies she worked on found that people are generally able to tell what stage of pregnancy they are in.

Several other studies have also shown that self management — proceeding without direct medical supervision — with this type of medicine is safe and effective.

“You also have to trust patients to know when it’s right for them and when not to seek help from a provider,” Upadhyay said.

The FDA has relaxed some federal regulations regarding medical abortion during the COVID-19 pandemic.

Since 2011, mifepristone has been subject to a type of restricted program that the FDA uses to ensure that the benefits of certain drugs outweigh any risks.

There are 62 drugs in these programs, including some drugs to treat cancer or MS, antipsychotics, opioids, and testosterone. These medications usually have contraindications and the program requires a provider to be certified to administer them. For some, the provider must follow a specific plan to educate the patient on how the drug works.

In December, the FDA allowed medical abortion pills to be mailed and said it would no longer enforce a rule that required people to get the first of two pills in person at a clinic or hospital.

Organizations like Choicea California-based telehealth organization for reproductive and sexual health, prescribed mifepristone to people who are not pregnant to expand access and empower the patient to access care when they need it with the support it deserves, Cindy Adam, CEO of Choice, said.

“Providing abortion care via telehealth, including advance provision, allows us to reduce the multitude of barriers to care that patients face and provides patients with peace of mind,” Adam said in an e -mail to CNN. “For some people, the time between finding out they are pregnant and receiving abortion pills in the mail can be extremely stressful and presents a series of challenges related to privacy, logistics, finances, their health , etc.”

A person using Choice is counseled on precautions to take while receiving the drug and is screened for risk factors like a previous ectopic pregnancy, abdominal surgery or sexually transmitted infection, Adam said. They are told to seek additional care if they become pregnant and to get a referral for in-person care if they need it.

“We are also proud to offer ongoing and supportive abortion care from our providers as part of our advance provision service to support patients through the process,” she said.

Politico said the FDA would not comment on whether it plans to change its restrictions or whether it plans to enforce its regulations by fining doctors or companies that prescribe mifepristone in a way that doesn’t. is not approved.

“Providers are quite capable of prescribing off-label drugs, and in fact some are prescribing mifepristone for up to 12 weeks” after a pregnancy, Upadhyay said. “Providers should be able to prescribe this drug as they see fit. It’s very safe, very effective.”

Given the current political climate and dramatically restricted access to abortion in the United States, Upadhyay said the FDA needs to take a more public health approach to abortion to ensure people can access these drugs.

The American College of Obstetricians and Gynecologists has asked the FDA to remove issues with access to medical abortion, though the organization has no policy on pre-prescribing these drugs.

“I think a lot of times people think that it’s only because the FDA says something that it’s true,” said Dr. Jen Villavicencio, the organization’s stock transformation manager. “They are not infallible.”

Villavicencio said “great data” shows that the additional steps providers need to take are “really inappropriate” based on the safety profile of the drugs.

To prescribe the abortion drug, providers must be certified and the patient must sign paperwork stating that she understands there is a risk of complications. These steps serve as a barrier to access, she said, rather than improving security.

“There have been more deaths linked to ibuprofen and Tylenol, which are over-the-counter and can be purchased by anyone. There have been more deaths linked to those over 22 since the mifepristone has been approved by the FDA that have been attributed to mifepristone or medical abortion,” Villavicencio said.

“It’s not evidence-based,” she added. “Mifepristone is one of the safest drugs anyone can take.”


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