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New labeling on TMP-SMX products warns of acute respiratory failure

from the Food and Drug Administration's Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health, Division of Anti-Infectives, and Office of Surveillance and Epidemiology
Published: July 2021
TOPICS: Pharmacology
Abstract
The warnings come after a case series published in Pediatrics described severe acute respiratory failure related to TMP-SMX treatment in five previously healthy adolescents, four of whom were treated for acne vulgaris.
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FDA encourages culture change for clinical trial enrollment of pregnant and lactating women

from the Food and Drug Administration’s Office of Pediatric Therapeutics, Office of Women’s Health, and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Division of Urology, Obstetrics, and Gynecology
Published: June 2021
TOPICS: Breastfeeding, Gynecology, Maternal and Fetal Medicine, Obstetrics, Urology
Abstract
While society is justifiably concerned about potential harms of clinical trial participation to a pregnant or lactating woman, excluding these individuals from research may do more harm by leaving gaps in knowledge.
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FDA adds prevention of oropharyngeal cancer to HPV vaccine’s indication

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Center for Biologics and Research
Published: May 2021
TOPICS: Adolescent Health/Medicine, Cancer/Neoplastic, Head and Neck Injuries, Vaccine/Immunization
Abstract
The expanded indication broadens the rationale for use to prevent HPV-related cancers in both sexes and includes individuals ages 9 through 45 years.
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2 potential biomarkers for ASD clear first step in FDA drug development tool qualification process

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Division of Psychiatry
Published: April 2021
TOPICS: Autism/ASD, Psychiatry/Psychology, Public Health
Abstract
The FDA accepted letters of intent for two proposed biomarkers for autism spectrum disorder from the Foundation for the National Institutes of Health Autism Biomarkers Consortium for Clinical Trials.
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FDA committed to advancing minority health

from the Food and Drug Administration's Office of Pediatric Therapeutics, Office of Minority Health and Health Equity and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: March 2021
TOPICS: Environmental Health, Infectious Diseases, Public Health, Social Media, Diversity, equity and inclusion
Abstract
The Food and Drug Administration (FDA) continues to work to eliminate health disparities among diverse racial and ethnic populations.
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First FDA-approved treatment for COVID-19 includes use in adolescents

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Division of Antivirals
Published: January 2021
TOPICS: Infectious Diseases, Pharmacology, COVID-19
Abstract
The Food and Drug Administration (FDA) has approved the antiviral Veklury (remdesivir) for treatment of COVID-19 requiring hospitalization in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms (kg).
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FDA approvals in 2020 represent many firsts for children

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: December 2020
TOPICS: Pharmacology
Abstract
Ebola treatment, an automated insulin device and two advanced therapeutics for pediatric rheumatologic conditions are among drugs approved for children.
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FDA engages patient communities through listening session initiative

from the Food and Drug Administration’s Office of Pediatric Therapeutics, Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Patient Affairs Staff
Published: November 2020
Abstract
Listening sessions give participants an opportunity to share their experiences living with a disease, insights into risk tolerance and preferences related to clinical trial participation.
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Pediatric information added to labeling for 80 drugs, vaccines, blood products

from the Food and Drug Administration’s Office of Pediatric Therapeutics, the Center for Drug Evaluation and Research, Division of Pediatric & Maternal Health and the Center for Biologics Evaluation and Research
Published: October 2020
Abstract
The Food and Drug Administration approved new pediatric-friendly dosage forms for products that treat chronic hepatitis C virus infection, stable symptomatic heart failure due to dilated cardiomyopathy and severe hypoglycemia.
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FDA addresses drug shortages during COVID-19 pandemic

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and Drug Shortage Staff
Published: August 2020
TOPICS: Infectious Diseases, Pharmacology, COVID-19
Abstract
Communication with manufacturers, health care professionals and the public is an essential component of the FDA’s efforts to prevent and mitigate drug shortages.
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FDA partners with global agencies on development of COVID-19 therapeutics for children

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: July 2020
TOPICS: Infectious Diseases, Pharmacology, Therapeutics, COVID-19
Abstract
Partnerships help ensure that children’s therapeutic needs are addressed without exposing pediatric patients to unnecessary clinical trials.
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FDA highlights imperative to obtain evidence through pediatric clinical trials

from the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: June 2020
Abstract
Delays in pediatric trials can result in prolonged off-label use of products in children without adequate information about dosing, safety and efficacy in pediatric patients.
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Drug labels include information on use in pediatric patients

the Food and Drug Administration’s Office of Pediatric Therapeutics and Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: April 2020
TOPICS: Advocacy, Child Care, Community Health Services, Community Pediatrics, Complementary & Integrative Medicine, Health Information Technology, Hospital Medicine, Legislation, Medical Education, Medical Technology and Advancement, Patient Education/Patient Safety/Public Education, Pharmacology
Abstract
The Physician Labeling Rule outlines the content and format of prescribing information for all new prescription drugs and biologics (and supplemental applications) approved on or after June 30, 2001.
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Update on success of law that encourages studies of off-patent drugs in children

National Institutes of Health, National Institute of Child Health and Human Development, and Food and Drug Administration’s Office of Pediatric Therapeutics and the Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: November 2019
TOPICS: Pharmacology
Abstract
Since Congress passed the Best Pharmaceuticals for Children Act in 2002, over 8,000 children have been enrolled in 40 clinical trials at over 200 pediatric sites, resulting in 11 label changes.
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Health professionals, patients urged to report adverse events

from the Food and Drug Administration’s Office of Pediatric Therapeutics and the Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health
Published: October 2019
TOPICS: Pharmacology
Abstract
The FDA reviews all reports from health professionals and consumers regarding potential safety concerns and may take regulatory action to protect the public health if a safety concern is identified.
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FDA approves 2 products to treat diabetes in pediatric patients

from the Food and Drug Administration’s Office of Pediatric Therapeutics, Division of Pediatric and Maternal Health, and Division of Metabolism and Endocrinology Products
Published: September 2019
TOPICS: Diabetes Mellitus, Pharmacology
Abstract
Victoza (liraglutide) is a glucagon-like peptide-1 receptor agonist and Baqsimi (glucagon) nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection.
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New FDA guidance documents inform pediatric labeling, study conduct

from the Food and Drug Administration’s Office of Pediatric Therapeutics, the Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and the Center for Biologics Evaluation and Research
Published: July 2019
TOPICS: Pharmacology
Abstract
These documents address numerous regulatory issues, including clinical trial design, human subject protections, safety evaluation and product quality standards.
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Pediatric information added to labels of 48 products in 2018

from the Food and Drug Administration’s Office of Pediatric Therapeutics, the Center for Drug Evaluation and Research, Division of Pediatric and Maternal Health and the Center for Biologics Evaluation and Research
Published: May 2019
TOPICS: Pharmacology
Abstract
New pediatric information was added to the labeling of 43 drugs, two vaccines, one allergen extract and two blood products.
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First drug to treat relapsing MS in pediatric patients approved

from the Food and Drug Administration’s Office of Pediatric Therapeutics, Division of Pediatric and Maternal Health, and Division of Neurology Products
Published: July 2018
TOPICS: Pharmacology
Abstract
The FDA recently approved Gilenya (fingolimod), a sphingosine 1-phospate receptor modulator, as the first treatment for relapsing forms of multiple sclerosis in pediatric patients 10 years of age and older.
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HIV-1 PrEP drug can be part of strategy to prevent infection in at-risk adolescents

from the Food and Drug Administration’s Office of Pediatric Therapeutics, Division of Pediatric and Maternal Health, and Division of Antiviral Products
Published: June 2018
Abstract
This combination antiretroviral is a single tablet dosed orally once daily in HIV-uninfected adolescents and adults weighing at least 35 kilograms (kg) to reduce the risk of sexually acquired HIV-1 infection.
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