New FDA Pregnancy and Lactation Labeling Rule for Prescription Medications | Priya Ravindranath, PharmD | RxEconsult

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New FDA Pregnancy and Lactation Labeling Rule for Prescription Drugs and Biologic Products Category: Women's Health by - December 24, 2014 | Views: 28788 | Likes: 0 | Comment: 0  

New FDA pregnancy and lactation label

On December 3, 2014, the United States Food and Drug Administration (FDA) published a rule regarding the labeling and presentation of medication information for patients who are pregnant or breastfeeding. The FDA is creating stricter requirements that will require more information to be published about risks and benefits associated with prescription medication use in this population. Additionally, the content will allow patients and their health care providers to make more informed decisions when choosing a medication.

This rule will be going into effect on June 30, 2015.

Why does this issue warrant attention?

Providing pregnant patients with more information is especially important. During pregnancy, most women take at least one medication. In the last three decades, the number of patients who use four or more medications during pregnancy has doubled. Often, many pregnant women have existing chronic conditions ( for example, asthma and high blood pressure) that require treatment with medications throughout the pregnancy. Additionally, as a patient’s body changes during pregnancy, medications may require dose adjustments.

What is the current rule and why should it be changed?

The focus of this new system is to provide the patient with more information about medications when they are pregnant. Currently, this sensitive information is presented in a vague “grading-system” format that downplays the risks associated with taking certain medications. The categories are as follows:

  • Category A – Good quality studies have not shown that there is a risk to the fetus during the first trimester of pregnancy (as well as subsequent trimesters).

  • Category B – Studies performed in animals have not shown a risk to the development of the fetus and there are no good quality studies that have been performed in pregnant women.

  • Category C – Studies performed in animals have shown adverse effects to the development of the fetus and there are no good quality studies that have been performed in pregnant women. However, potential benefits may outweigh the risks.

  • Category D – Studies show that there is evidence of adverse events and human fetal risk. However, potential benefits may outweigh the risks.

  • Category X – Studies in animals or humans have shown fetal abnormalities with risk to the human fetus based on adverse reactions of the drug. The risks outweigh the benefits.

Unfortunately, these categories could be misleading to healthcare providers and patients who take these drugs. Many patients believe that the risk increases incrementally as the category changes from A to X. However, this is untrue. In actuality, the categories are intended to weigh the risks versus benefits. This means that a drug that is labeled “Pregnancy Category C” may actually have the same risks as a drug labeled “Pregnancy Category X”. Additionally, the vague lettering system does not always provide details about prevalence, severity, or type of fetal developmental abnormalities associated with the use of the drug. The new rule would ensure that these categories are removed and replaced with more consistent information.

What are the requirements for the new rule?

As it stands, the specific populations section contains three different categories: Pregnancy, Labor and Delivery, and Nursing mothers. Under the new labeling system, Labor and Delivery are included in the Pregnancy category. Nursing mothers has now been relabeled as Lactation and a new category has been introduced called “Females and Males of Reproductive Potential”.

In the new system the pregnancy and lactation subsections will contain three important components: a risk summary weighing benefits and risks, clinical considerations that should be made based on the specific patient, and a data section that will detail the results of the studies.

The pregnancy subsection:

The fetal risk summary will contain one sentence that summarizes the likelihood of the drug causing increased risk of four types of fetal developmental abnormalities. These abnormalities include:

  • Structural anomalies

  • Chance of fetal and infant death

  • Altered physiologic function

  • Changes in ability to grow

The summary will mention whether the studies were performed in animals or humans. If the studies were performed in humans, a more detailed paragraph will follow to inform the patient about the nature and severity of the effects that the drug may have on the fetus.

The clinical considerations section will provide information for the prescriber to discuss with the patient. This information will include the three main topics that are important to mention when counseling about the medication.

A section about accidental exposure tells a patient about the known or potential risks to the fetus if a patient takes the medication early in pregnancy. There will be data specific to dose, timing during pregnancy, and length of exposure to the medication.

There will also be a section that will aid healthcare providers when making decisions for pregnant women. This section will contain information about the risks that may happen to the patient and the fetus, any dose adjustments, adverse reactions and monitoring parameters specific to pregnancy, and complications that may arise during use. This section will also detail any effects the drug may have during labor and delivery.

Lastly, the data section will contain a discussion of available data. This would include a detailed description of the studies performed, doses used, developmental anomalies observed and the reasoning for why the drug may have caused them.

At the end of the section, patients will be given the option to enroll in a registry that tracks drug exposure and will be given a general statement about that all pregnancies have risks regardless of drug exposure.

Lactation subsection:

The risk summary details if the drug may be used in breastfeeding and what effects it may have on milk production. This includes the amount of drug that may be present in breast milk as well as the effects it may have on the child.

The clinical considerations sections informs the patient how they may minimize exposure of the drug as well as potential drug effects that may be seen in a breast-feeding child.

The data section gives a general overview of the data that determined the risk summary and clinical considerations.

How will this change impact patients, prescribers, and drug manufacturers?

Often, patients will take medications when they are pregnant because they do not understand the risks associated with it. For example, hydrocodone is classified as pregnancy Category C. This means that there is a potential for hydrocodone to cause birth defects if used during pregnancy but specific data was not provided. However, a study performed by the Centers for Disease Control found that babies who had exposure to opioid medications early during the first trimester of pregnancy were twice as likely to develop Hypoplastic Left Heart Syndrome (HLHS). HLHS is a fatal congenital heart defect that prevents development of the left side of the heart resulting in inability for the heart to pump blood. Ideally patients should be warned of this side effect, but manufacturers were never required to provide a warning. With the new system, this type of data and warning will be made readily available.

Patients will have this information available at their fingertips. Instead of a confusing letter system, the risks and benefits will be concisely presented. This will empower them to make decisions about their own treatment as well as for their future children.

The additional information provided will allow health care providers to make more educated decisions when prescribing medications to their patients. They will be able to weigh the benefits and risks when choosing a medication and will be able to convey this information more confidently to their patients.

Drug manufacturers who introduce new drugs into the market after June 30, 2015, will have to use the new format on the labels. However, drugs that were approved after June 30, 2001, will switch to the new label format within the next three years. This means that all scientific communication and promotional materials that discuss pregnancy and lactation need revision to comply with the label changes. As this change is specific to prescription medications, OTC medication labels will not be impacted.

For more information about drugs and pregnancy read drugs to avoid during pregnancy.


United States Food and Drug Administration: Pregnancy and Lactation Labeling Final Rule.

United States Food and Drug Administration: Summary of Proposed Rule on Pregnancy and Lactation Labeling

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