Pregnancy, Lactation, and Reproductive Potential Labeling Rule

Chi Lan TrinhHelen Tesfaye

I N T R O D U C T I O N

•7 out of 10 pregnant women in the US are prescribed at least one medication2 •Safety in pregnancy data for only 10% of drugs•Current pregnancy categories: A, B, C, D, X

• Results in under-treatment or lack of treatment• Prescribers not assessing patient-specific risks and

benefits• Inconsistencies among prescribers and other healthcare

providers •FDA is amending the labeling content and format of “Pregnancy,” “Labor and Delivery.” and “Nursing mothers” subsections of the “Use in Specific Populations” section and the “Precautions” section1

O B J E C T I V E

•Provide explanations and clarifications on the changing FDA pregnancy categories•Bring awareness to prescribers, healthcare professionals, and patients regarding these changes•Purpose of the new FDA ruling•Provide insight into the most commonly used prescription medications

A B S T R A C T

FDA’s pregnancy category has been used for more than three decades in guiding prescription decisions in pregnant and lactating women. This system does not take into account inter-patient differences and does not prompt providers to review medical literature, pregnancy registries, and package inserts prior to prescribing. Additionally, the current labeling guidelines for prescription drugs and biologic products makes accessing such information a difficult task. The new labeling rule by FDA amends the pregnancy categories – reorganizing the previously existing subsections into “Pregnancy" and “Lactation,” and creating an entirely new section for “Females and Males of Reproductive Potential.” The goal is to resolve the previously mentioned issues in prescribing medications to pregnant women. However, we foresee potential issues in the implementation of these new categories.

M E T H O D S

•FDA’s final ruling on “Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling” published in the Federal Register on December 4, 2014•Statistics about medication use in pregnancy was obtained from CDC’s Treating for Two•Drugs@FDA was used as a source for drug approval dates

D A T A

•Removal of A, B, C, D, X categories from human prescription drug and biological product labeling.•New labeling rule effective June 30, 20151

•Drugs approved after June 30, 2015 will use new drug labeling1

•Drugs approved on or after June 30, 2001 will be phased in gradually1

•Drugs approved prior to June 30, 2001 – voluntary •Commonly prescribed drugs during pregnancy in the past 30 days: Levothyroxine, Antibiotics, Insulin, Albuterol, Promethazine, Cetirizine, Montelukast, Budesonide2

R E S U L T S

•All of the most common drugs prescribed to pregnant women in the past 30 days and many of the top 200 drugs were approved prior to June 30, 2001•New ruling’s focus is limited to prescribers•New labeling rule takes into account inter-patient differences and assists in providing individualized care•Ready access to information on package insert for drugs approved after June 30, 2015•Labeling will be more informative and accurate, and should be continuously updated when new human data becomes available

C O N C L U S I O N S

•Prescribers cannot determine treatment simply based on a letter• Prescribers required to thoroughly research medication and

safety data during pregnancy• More patient-specific

•Avoid under-treatment and lack of treatment in pregnant and lactating women, as well as encourage providers and patients to use pregnancy registries•Healthcare providers may have difficulty transitioning between the pregnancy category and the labeling rule especially for common drugs approved prior to June 30, 2001 •Limited time during visits to healthcare professionals

• Potential obstacle in utilization of new categories

R E F E R E N C E S

•1”Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling.” Federal Register. Web. 20 Mar. 2015. <https”www.federalregister.gov/articles/2014/12/04-28242/pregnancy-lactation-and-reproductive potential-labeling-for-human-prescription-drug-and-biological>•2“Data and Statistics.” Centers for Disease Control and Prevention. Centers for Disease Control and Prevention, 19 Feb. 2014. Web. 26 Mar. 2015. •<http://www.cdc.gov/pregnancy/meds/treatingfortwo/data.html>/•3“Drugs@FDA: FDA Approved Drug Products.” Drugs@FDA:Fda Approved Drug Products. Web. 25 Mar. 2015. <http://www.accessdata.fda.gov/scripts/cder/drugsatfda/>•4“Facts.” Centers for Disease Control and Prevention. Centers forDisease Control and Prevention, 16 Jan. 2015. Web. 26 Mar. 2015. <http://www.cdc.gov/pregnancy/meds/treatingfortwo/facts.html>/

Pregnancy

Labor and Delivery

Nursing Mothers

Pregnancy

•Includes labor and delivery

Lactation

•Includes nursing mothers

NEW!

Females and Males of Reproductive Potential