Related Experiment Video
Updated: Jul 26, 2026
11:08
The Use of Gas Chromatography to Analyze Compositional Changes of Fatty Acids in Rat Liver Tissue during Pregnancy
Published on: March 13, 2014
FDA labeling system for drugs in pregnancy
1College of Pharmacy, Auburn University, GA, USA. lisa.boothby@crhs.net
The Annals of Pharmacotherapy
|November 29, 2001
Summary
The current Food and Drug Administration (FDA) pregnancy drug labeling system has limitations, with only 40% of drugs categorized. A new system aims for better clinical usefulness using pregnancy registry data.
Area of Science:
- Pharmacovigilance
- Drug safety in pregnancy
- Regulatory science
Background:
- The current Food and Drug Administration (FDA) pregnancy labeling system lacks comprehensive drug categorization.
- Limited data availability necessitates alternative methods for assessing pregnancy risks.
Purpose of the Study:
- Review the existing FDA pregnancy labeling system.
- Examine the proposed FDA pregnancy labeling system's structure and content.
- Evaluate the suitability of the new system for implementation.
Main Methods:
- Data sourced from FDA website, PubMed, Federal Register, LexisNexis, PDR, Drugdex, and Current Contents.
- Inclusion of research on drugs and pregnancy/lactation, and FDA subcommittee meeting minutes.
- Analysis of prospective, case-control studies from pregnancy registries.
Main Results:
- Only 40% of drugs in the Physician's Desk Reference (PDR) currently list pregnancy categories.
- Healthcare professionals utilize methods like chart reviews, case reports, and expert consultations to assess risks.
- Existing system's limitations drive reliance on alternative risk assessment strategies.
Conclusions:
- The proposed FDA pregnancy labeling system emphasizes human data from pregnancy registries for improved clinical utility.
- The ultimate clinical usefulness of the revised labeling system requires further observation and evaluation.
More Related Videos
15:27Construction of Vapor Chambers Used to Expose Mice to Alcohol During the Equivalent of all Three Trimesters of Human Development
Published on: July 13, 2014
09:04Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods
Published on: September 10, 2018
Related Concept Videos
01:17Drug Nomenclature
During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that the same...
01:25Drug Regulation
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
01:07Teratogenicity
The ability of a drug to produce structural deformations and functional abnormalities in the developing embryo or the fetus is called teratogenicity, and the drug producing this effect is known as a teratogen. Teratogenic effects include stillbirth, miscarriage, intrauterine growth restriction, and neurocognitive delay. A teratogen may affect the embryo at different stages of development, which is important in determining the type and extent of the damage. During blastocyst formation, the early...
01:25Physiological Barriers
Physiological barriers are semi-permeable cellular structures restricting drug diffusion into intracellular compartments and tissues. There are six types of physiological barriers: blood endothelial, cell membrane, blood-brain, blood-cerebrospinal fluid (CSF), blood-placenta, and blood-testis barriers.
The blood endothelial barrier is the most porous of these. It allows all small ionized, un-ionized, and lipophilic molecules to pass through the endothelial lining into the interstitial space...
The blood endothelial barrier is the most porous of these. It allows all small ionized, un-ionized, and lipophilic molecules to pass through the endothelial lining into the interstitial space...
01:26FDA Approved Drugs: Changes to Approved Drugs
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
01:21Intrauterine Drug Delivery Systems
Controlled-release systems for intravaginal and intrauterine drug delivery have been developed primarily for the administration of contraceptive steroid hormones. These delivery routes circumvent first-pass hepatic metabolism, thereby enhancing bioavailability and allowing for reduced systemic dosages compared to oral administration. Such approaches contribute to improved therapeutic efficacy and patient compliance, particularly in long-term contraceptive regimens.Intravaginal Drug Delivery...