Mohamad-Ali Salloum is a Pharmacist and science writer. He loves simplifying science to the general public and healthcare students through words and illustrations. When he's not working, you can usually find him in the gym, reading a book, or learning a new skill.
FDA pregnancy medication Labelling : Post 2015.
Mohamad Ali Salloum, PharmD • April 2, 2022
Share
Starting from 30 June 2015, the FDA implemented a new labelling rule for medications used during pregnancy and lactation.
As discussed in the previous article, the Categories published in 1979 (A, B, C, D, and X) were causing confusion for the patients and are increasing the risk to be misinterpreted by the health care professionals.
The new format is called the “Pregnancy and Lactation Labelling Rule” and is abbreviated as PLLR.
Using PLLR will remove some of the uncertainty that was caused by the previous five categories since it will contain a narrative information about the medication that will describe the potential risks of drug exposure based on available, evidence-based data. Ultimately, the new format will assist the health care professionals to assess the benefit versus risk when counseling pregnant women and nursing mothers who need the medication, and thus leading to enhanced protection of the mother and her baby.
After the PLLR was implemented, every pharmaceutical company that wants to register it’s new drug in the FDA, It should use the template provided by the FDA to include the required information in the leaflet.
Regarding the medications that were approved by FDA after 30 June 2001, The manufacturer was given from two to four years after 2015 to change the information on the leaflet as required.
Meanwhile, for the medications that were approved by the FDA before 30 June 2001, the format of the information was not required to be changed, however, It was mandated to remove the categorization that was assigned to this medication. The deadline for this action was 30 June 2018.
Concerning the OTC drugs, medications that can be given without a prescription, they were not affected by the new rule.
Not only the letter categorization was removed, the FDA also required the manufacturer to modify the sections in the leaflet.
The below picture will illustrate the modification on sections done between the 2 formats.
Briefly describing the change in the sections:
-The FDA decided to merge "Labor and Delivery" with the "Pregnancy" in section 8.1.
-Section 8.2 was named "Lactation".
-A new section was added, which is 8.3. and it described the information regarding the females and males of reproductive potential.
Speaking about this new section, it's very important to inform the physician about every drug that is being administered by the father or the mother of the baby. Also, if the couple were planning to have a baby, then they should discuss with the doctor about the drugs that being are being administered since a lot of drugs can remain in your body even after discontinuing it. (some medications can stay for weeks and even months in our bodies).
List of Services
ABOUT THE AUTHOR
Mohamad-Ali Salloum, PharmD
Share
Recent articles:
A clear, evidence‑based guide to Ramadan fasting, explaining its metabolic, mental, and cardiometabolic benefits, plus practical nutrition, hydration, sleep, and medication strategies for healthy adults and high‑risk patients.
A practical guide to shifting from blaming “human error” to applying ICH GCP E6(R3) system‑level quality, Quality by Design, and risk‑based oversight to prevent repeat deviations in clinical trials.
Learn 5 Whys and Fishbone (Ishikawa) for Root Cause Analysis in clinical research, with practical examples and an interactive quiz—no fluff, just clarity.
A clear, practical guide to CAPA for Clinical Research Associates—covering corrective and preventive actions, real‑world scenarios, and an interactive quiz to reinforce learning.
Boost your health with a simple 30‑minute morning walk backed by science—better heart health, mood, sleep, and energy.
References: Gunes IB, Gunes A. Association Between Eyelid Twitching and Digital Screen Time, Uncorrected Refractive Error, Intraocular Pressure, and Blood Electrolyte Imbalances. Cureus . 2024;16(9):e69249. Available from: https://www.cureus.com/articles/291035-association-between-eyelid-twitching-and-digital-screen-time-uncorrected-refractive-error-intraocular-pressure-and-blood-electrolyte-imbalances Banik R, Miller NR. Chronic myokymia limited to the eyelid is a benign condition. J Neuroophthalmol . 2004;24(4):290–2. Available from: https://scholars.mssm.edu/en/publications/chronic-myokymia-limited-to-the-eyelid-is-a-benign-condition-2 Hallett M. Blepharospasm: recent advances. Neurology . 2002;59(11):1759–60. Available from: https://europepmc.org/abstract/MED/12434791 Defazio G, Livrea P. Epidemiology of primary blepharospasm. Mov Disord . 2002;17(1):7–12. Available from: https://europepmc.org/article/MED/11835433 Zeppieri M, Ameer MA, Jahngir MU, Patel BC. Meige Syndrome. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. Available from: https://europepmc.org/article/MED/30020730 Zhang Y, Adamec I, Habek M. Superior oblique myokymia: a meta-analysis. J Ophthalmol . 2018;2018:7290547. Available from: https://doi.org/10.1155/2018/7290547 Costa J, Espírito-Santo C, Borges A, et al. Botulinum toxin type A therapy for blepharospasm. Cochrane Database Syst Rev . 2020;11:CD004900. Available from: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD004900.pub2/abstract Khalkhali M. Topiramate-induced persistent eyelid myokymia. Case Rep Psychiatry . 2016;2016:7901085. Available from: https://europepmc.org/articles/PMC4886081/
References: Sen A, Tai XY. Sleep duration and executive function in adults. Curr Neurol Neurosci Rep. 2023;23:801–813. [link.springer.com] Nature Research Intelligence. Sleep deprivation and cognitive performance. Nature Portfolio. 2023. Available from: https://www.nature.com/… [nature.com] Skourti E, Simos P, Zampetakis A, et al. Long-term associations between objective sleep and verbal memory performance. Front Neurosci. 2023;17:1265016. [frontiersin.org] Hauglund NL, Andersen M, Tokarska K, et al. Norepinephrine‑mediated slow vasomotion drives glymphatic clearance during sleep. Cell. 2025;188(3):606‑622.e17. [cell.com] Shirolapov IV, Zakharov AV, Smirnova DA, et al. The role of the glymphatic clearance system in sleep–wake interactions and neurodegeneration. Neurosci Behav Physiol. 2024;54:199–204. [link.springer.com] Kong Y, Yu B, Guan G, et al. Effects of sleep deprivation on sports performance: a systematic review and meta-analysis. Front Physiol. 2025;16:1544286. [frontiersin.org] Gong M, Sun M, Sun Y, et al. Effects of acute sleep deprivation on sporting performance in athletes. Nat Sci Sleep. 2024;16:—. [tandfonline.com] Dean B, Hartmann T, Wingfield G, et al. Sleep restriction between consecutive days of exercise impairs cycling performance. J Sleep Res. 2023;32(3):e13857. [onlinelibr....wiley.com] Mah CD, Mah KE, Kezirian EJ, Dement WC. The effects of sleep extension on athletic performance in collegiate basketball players. Sleep. 2011;34(7):943–950. [psycnet.apa.org] Cunha LA, Costa JA, Marques EA, et al. Impact of sleep interventions on athletic performance: a systematic review. Sports Med Open. 2023;9:58. [link.springer.com] Teece AR, Beaven CM, Argus CK, et al. Daytime naps improve afternoon power and perceptual measures in elite rugby union athletes. Sleep. 2023;46(12):zsad133. [academic.oup.com] Mesas AE, Núñez de Arenas-Arroyo S, Martinez-Vizcaino V, et al. Daytime napping and cognitive/physical sport performance: meta-analysis of RCTs. Br J Sports Med. 2023;57(7):417–27. [bjsm.bmj.com] Haines Roberts SS, Teo WP, Warmington SA. Effects of training and competition on the sleep of elite athletes. Br J Sports Med. 2019;53(8):513–522. [bjsm.bmj.com] Walsh NP, Halson SL, Sargent C, et al. Sleep and the athlete: 2021 expert consensus recommendations. Br J Sports Med. 2021;55(7):356–368. [bjsm.bmj.com] Janse van Rensburg DC, Fowler PM, Racinais S. Practical tips to manage travel fatigue and jet lag in athletes. Br J Sports Med. 2021;55(15):821–822. [bjsm.bmj.com] Watson NF, Badr MS, Belenky G, et al. Recommended amount of sleep for a healthy adult: AASM/SRS consensus statement. Sleep. 2015;38(6):843–844. [aasm.org] Centers for Disease Control and Prevention. FastStats: Sleep in adults. CDC. 2024. Available from: https://www.cdc.gov/sleep/… [cdc.gov]
References: Gooley JJ, Chamberlain K, Smith KA, et al. Exposure to room light before bedtime suppresses melatonin onset and shortens melatonin duration in humans. J Clin Endocrinol Metab. 2011;96(3):E463‑E472. [academic.oup.com] Chang AM, Aeschbach D, Duffy JF, Czeisler CA. Evening use of light‑emitting eReaders negatively affects sleep, circadian timing, and next‑morning alertness. Proc Natl Acad Sci USA. 2015;112(4):1232‑1237. [hms.harvard.edu] Schöllhorn I, Stefani O, Lucas RJ, et al. Melanopic irradiance defines the impact of evening display light on sleep latency, melatonin and alertness. Commun Biol. 2023;6:1090. [nature.com] He J‑W, Tu Z‑H, Xiao L, Su T, Tang Y‑X. Effect of restricting bedtime mobile phone use on sleep, arousal, mood, and working memory: A randomized pilot trial. PLoS One. 2020;15(2):e0228756. [journals.plos.org] Hartstein LE, Mathew GM, Reichenberger DA, et al. The impact of screen use on sleep health across the lifespan: a National Sleep Foundation consensus statement. Sleep Health. 2024;10(4):373‑384. [sleephealt…ournal.org] Höhn C, Hahn MA, Gruber G, et al. Effects of evening smartphone use on sleep and declarative memory consolidation in male adolescents and young adults. Brain Commun. 2024;6(3):fcae173. Finucane E, O’Brien A, Treweek S, et al. Does reading a book in bed make a difference to sleep? The People’s Trial—an online, pragmatic randomized trial. Trials. 2021;22:873. [link.springer.com] Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. Sleep. 2014;37(9):1553‑1563. [academic.oup.com] , [mindfulchair.com] He X, Pan B, Ma N, et al. The association of screen time and the risk of sleep outcomes: a systematic review and meta‑analysis. Front Psychiatry. 2025;16:1640263. Shechter A, Quispe KA, Mizhquiri Barbecho JS, et al. Interventions to reduce short‑wavelength light at night and their effects on sleep: systematic review and meta‑analysis. SLEEP Advances. 2020;1(1):zpaa002. [academic.oup.com]
References: Harkin B, Webb TL, Chang BPI, Prestwich A, Conner M, Kellar I, et al. Does monitoring goal progress promote goal attainment? A meta-analysis of the experimental evidence. Psychol Bull . 2016;142(2):198–229. Available from: https://www.apa.org/pubs/journals/releases/bul-bul0000025.pdf Compernolle S, DeSmet A, Poppe L, Crombez G, De Bourdeaudhuij I, Cardon G, et al. Effectiveness of interventions using self-monitoring to reduce sedentary behavior in adults: a systematic review and meta-analysis. Int J Behav Nutr Phys Act . 2019;16(1):63. Available from: https://link.springer.com/article/10.1186/s12966-019-0824-3 Patel ML, Brooks TL, Bennett GG. Consistent self‑monitoring in a commercial app‑based intervention for weight loss: results from a randomized trial. J Behav Med . 2020;43:391–401. Available from: https://link.springer.com/article/10.1007/s10865-019-00091-8 Patel ML, Hopkins CM, Brooks TL, Bennett GG. Comparing self-monitoring strategies for weight loss in a smartphone app: randomized controlled trial. JMIR Mhealth Uhealth . 2019;7(2):e12209. Available from: https://mhealth.jmir.org/2019/2/e12209/ Lally P, Van Jaarsveld CHM, Potts HWW, Wardle J. How are habits formed: Modelling habit formation in the real world. Eur J Soc Psychol . 2010;40(6):998–1009. Available from: https://repositorio.ispa.pt/bitstream/10400.12/3364/1/IJSP_998-1009.pdf Singh B, Murphy A, Maher C, Smith AE. Time to form a habit: A systematic review and meta-analysis of health behaviour habit formation and its determinants. Healthcare (Basel) . 2024;12(23):2488. Available from: https://www.mdpi.com/2227-9032/12/23/2488 Gollwitzer PM, Sheeran P. Implementation intentions and goal achievement: A meta‑analysis of effects and processes. In: Advances in Experimental Social Psychology . 2006;38:69–119. Available from: https://www.researchgate.net/publication/37367696 Adriaanse MA, Gollwitzer PM, De Ridder DTD, De Wit JBF, Kroese FM. Breaking habits with implementation intentions: A test of underlying processes. Pers Soc Psychol Bull . 2011;37(4):502–13. Available from: https://dspace.library.uu.nl/bitstream/handle/1874/380229/0146167211399102.pdf Palmer CA, Bower JL, Cho KW, Clementi MA, Lau S, Oosterhoff B, et al. Sleep loss and emotion: A systematic review and meta-analysis of over 50 years of experimental research. Psychol Bull . 2023;149(11):2314–48. Available from: https://www.apa.org/pubs/journals/releases/bul-bul0000410.pdf Kong Y, Yu B, Guan G, Wang Y, He H. Effects of sleep deprivation on sports performance and perceived exertion in athletes and non-athletes: a systematic review and meta-analysis. Front Physiol . 2025;16:1544286. Available from: https://www.frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1544286/full Tadros M, Newby JM, Li S, Werner‑Seidler A. Psychological treatments to improve sleep quality in university students: systematic review and meta-analysis. PLoS One . 2025;20(2):e0317125. Available from: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0317125 Locke EA, Latham GP. Building a practically useful theory of goal setting and task motivation: A 35‑year odyssey. Am Psychol . 2002;57(9):705–17. Available from: https://med.stanford.edu/content/dam/sm/s-spire/documents/PD.locke-and-latham-retrospective_Paper.pdf