Displaying items by tag: FDA

Understanding the Removal of REMS Restrictions

How does this FDA decision affect your center, your clients and your community?

What did the US Food & Drug Administration decide last week about the abortion drug mifepristone?

Considerable changes were made to the Risk Evaluation and Mitigation Strategy (REMS) safety program. These changes affect how it can be prescribed and dispensed. This decision by the FDA will affect thousands of women in the coming year.

What is the REMS and why was this placed on mifepristone?

There are over 20,000 prescription drugs approved by the FDA, there are just 74 medications deemed so dangerous to warrant a REMS restriction and one of these was mifepristone.

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

This was one last safety barrier in place for chemical abortion of a process that’s been shown to be four times more dangerous than surgical abortion.

The REMS for mifepristone was intended to minimize the significant risk of hemorrhage, retained fetal tissue, and infection – symptoms that can quickly become life-threatening for women. This was not restrictive – it was protective of the thousands of women who take this drug every year in the US.

Is mifepristone actually dangerous?

We really do not have a true picture of the dangers of mifepristone because the FDA made the decision in 2016 to stop collecting data on nonfatal adverse events related of mifepristone - instead they have only been collecting data on maternal fatalities related to the drug. Unless women actually died, they did not make note of the complications or injuries to women caused by mifepristone for more than five years. With only voluntary reporting, no one in America is systematically collecting data on the women hurt or killed by mifepristone complications. 

However, recent analysis of the Adverse Events submitted to the FDA with the REMS in place shows over 3000 women suffering with complications, of which 24 of those women died, and another 500 would have died if they had not reached emergency medical care in time. And we know that up to 7% of women will need surgical intervention after a chemical abortion.

Mifepristone causes pain and bleeding that can become perilous, but the FDA also warns women to expect nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness in the first day or two. Chemical abortion is quite a miserable experience for nearly all women who take these drugs, dangerous for the thousands suffering complications and can even be deadly for the most unfortunate. 

Why was the REMS altered?

The FDA said it made changes "to minimize the burden on the healthcare delivery system" and "to ensure that the benefits of the drug outweigh the risks." Sadly, the FDA has chosen to ignore the thousands of women in need of emergency care who were injured by chemical abortion and has caved to the pressures of ACOG, World Health Organization, the American Medical Association and Big Abortion.

Will chemical abortion be prescribed by telemedicine and mail order now?  

Although the FDA continues to allow in-person dispensing at a clinic or other medical setting, the FDA removed the requirement that it must be dispensed in person. This means that abortion pills can now be sent in the mail across state lines without seeing a doctor. Regrettably, telemedicine has emerged as a viable option to expand the availability of abortion. By lifting the REMS, the FDA has allowed providers in states without telehealth restrictions to dispense mifepristone without a clinic visit. There is much risk in not providing assessment for ectopic pregnancy, accurate determination of gestational age, testing and treatment for Rh- incompatibility, fully informed consent, and assessment for coercion prior to prescribing mifepristone.

Who can prescribe and dispense mifepristone?

Mifepristone must be prescribed by or under the supervision of a certified healthcare provider who meets certain qualifications. The prescriber must sign a Prescriber Agreement Form with the manufacturer and patients must still sign a "Patient Agreement Form.” When signing this form, women agree they were counseled regarding the dangers of bleeding, infection and ectopic pregnancy; the failure rate of chemical abortion (estimated by the manufacturer to be 3-7%); and what to do in the event of emergency symptoms. They also must agree to take the second drug, misoprostol, 24-48 hours later, which inappropriately seems to remove their rights to withdrawal their informed consent if they wish to continue their pregnancies. They are also provided with a letter to take to the emergency department if symptoms require urgent medical care.

Is mifepristone allowed by prescription?

Previously, mifepristone was not available by prescription at commercial pharmacies. Women couldn’t just pick it up at Walgreens or CVS; it was most frequently prescribed and dispensed at an abortion facility. The FDA is now allowing prescriptions at certified pharmacies, helping to facilitate e-prescriptions for mifepristone. This certification is between the pharmacy and the manufacturer of the abortion drug and is not regulated by the FDA.

How do we help clients considering abortion drugs?

Informed consent is the idea that patients have the right to know as much information as possible about the risks and benefits of a medical procedure and use that knowledge to decide whether they want to receive the procedure. There are many ways your center can assist women to be fully informed about their pregnancy decisions:

  • Share information about the medical process she is about to undertake.
  • If you need more information, Heartbeat Academy has a course called Abortion Procedures Information for Pregnancy Help Organizations
  • The American Association of Prolife Obstetricians and Gynecologists offers guidance regarding counseling the abortion vulnerable patient and medical abortion. Their information is evidence-based and defends the lives of both the pregnant mother and her pre-born child.
  • Life Institute has a training documentary regarding chemical abortion.
  • Encourage all pregnant clients to have a scan at your center for accurate fetal heart rate and assessment of viability, location, and dating prior to making a pregnancy decision.
  • Share the truth about fetal development with your client. The Endowment for Human Development has recently shared a new free tablet app for educators called the Little One Pregnancy Guide. This resource helps show parents what is going on during the developmental journey of their preborn child. You can also encourage clients to actively follow their baby's growth in the womb.
  • Spend as much time as needed answering questions with families regarding the ultrasound report, fetal development, and chemical abortion as well as the help and support that is available to her as she moves forward with a pregnancy decision.

If your client has started a chemical abortion and has regret, she can learn more about reversing the effects of chemical abortion and possibly continuing her pregnancy by contacting the Abortion Pill Rescue® Network hotline 877.558.0333 or at the APR website to begin a live chat. We have a team of nurses waiting to answer questions, explain reversal, and connect her with an APRN Provider in her area.

Women deserve to know the truth; they don’t give up that right when they seek an abortion. Help is available for women who have taken the first abortion pill and experience regret. APRN offers the chance to reverse the effects of the chemical abortion pill and potentially continue their pregnancies. Statistics show that more than 2,500 babies have been saved through the APRN.

FDA approves morning sickness drug Diclegis

by Susan Dammann, Medical Specialist, LAS

On April 9, the U.S. Food and Drug Administration approved the morning sickness drug Diclegis, 30 years after it was pulled from the market due to concerns that it caused birth defects.

Diclegis is a delayed-release tablet, a combination of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a form of vitamin B6, and is used to treat pregnant women who have not responded well to other means of dealing with morning sickness.

Although both substances have been prescribed separately for several years, this combination is an extended release formula, intended to stop the morning sickness before it begins. Sometimes the conservative treatment of eating smaller meals, eating low fat or bland foods which are easier to digest, and avoiding smells that can trigger nausea are not adequate in controlling the symptoms of morning sickness.

According to the FDA’s press release announcing its approval, the recommended starting dosage of Diclegis is two tablets at bedtime. However, “[if] symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime).”

An article printed in Medscape from WebMD tracks the history of Diclegis, particularly why it was first pulled from the market 30 years ago and what has changed to allow the drug to hit the market again, which is expected to take place in May.

Diclegis was previously sold in the United States under the brand name Bendectin between 1956 and 1983, but it was pulled from the market because of litigation about birth defects. Although ongoing research has shown that the concerns were unsupported, the drug's previous maker, Merrell Dow Pharmaceuticals, declined to keep making the drug because of the high costs of defending it.

Edward McCabe, MD, medical director for the March of Dimes, told the Associated Press that the birth defect rate was the same among women who used the drug as in those in the general population, creating the false impression that the drug caused the birth defects. "Nothing better has come along" to treat morning sickness in the 30 years since it was taken off the market, Dr. McCabe said. The FDA at the time continued to call the drug safe.

Though Diclegis has been researched, the fact remains that we do not know what effects this drug may have once it hits the general population. Therefore, it should probably be reserved for more severe cases.

Heartbeat recommends that you research and discuss this medication with your medical director, and develop your center’s policy for advising and assisting clients who experience severe morning sickness symptoms.

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