FDA Perspectives on the Use of Teratology Data for Human Risk Assessment

Frankos, Vasilios H.

doi:10.1093/toxsci/5.4.615

Cited by 19 publications

(26 citation statements)

References 3 publications

(3 reference statements)

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“…Safe and efficacious use of drugs prevents morbidity and mortality in mother and foetus. Hence, our objective of the study was to study the morbidity pattern, drug use pattern in indoor patients of high risk pregnancy at Obstetrics and Gynaecology department in a tertiary care teaching hospital; to evaluate the drug use pattern Using US-FDA Drug Risk Category 3 , WHO core drug prescribing indicators 4 and to find out the average cost of treatment per patient.…”

Section: Introductionmentioning

confidence: 99%

A study of morbidity and drug utilization pattern in indoor patients of high risk pregnancy at tertiary care hospital

Patel

Joshi

Patel

2013

Int J Reprod Contracept Obstet Gynecol

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Background: Pregnancy represents a special physiological state during which the use of drug is of growing concern due to risk of teratogenicity. High risk pregnancy is common threat to mother and foetus. Therefore, our aim was to study the drug utilization and morbidity pattern in high risk pregnancy in hospitalized pregnant women. Methods: An observational, prospective study was carried out in 250 patients for 6 months in the tertiary care hospital. Protocol was approved by the Institutional Review Board (IRB). The data were collected in a pre-designed proforma. Data were analysed by using SPSS version 20.0 Software. Results: Among 250 patients, 19 (7.6%), 218 (87.2%) and 13 (5.2%) were of less than 20, 20 to 30 and more than 30 years of age respectively. About 68.8% women had complained of abdominal pain and 67.6% had weakness followed by headache / body ache (47.2%), oedema (26.4%) and vomiting (18.8%). Iron (91.2%) and calcium (84.5%) were the commonest drugs prescribed followed by folic acid (59.6%), protein powder (54.8%), vitamin C (46.8%) and isoxsuprine (26.6%). As per FDA Drug Risk Category, Category-A (82.21%) was most frequently prescribed followed by Category-B (15.64%) and Category-C (2.15%). Percentage of drugs prescribed by generic name and from essential drug list was 62.80% and 80.79%. Conclusion: Iron, Calcium and Folic acid were most commonly prescribed drugs. There is lesser number of drugs prescribed by generic name suggesting need for sincere efforts to improve situation. [Int J Reprod Contracept Obstet Gynecol 2013; 2(3.000): 372-378

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Section: Introductionmentioning

confidence: 99%

A study of morbidity and drug utilization pattern in indoor patients of high risk pregnancy at tertiary care hospital

Patel

Joshi

Patel

2013

Int J Reprod Contracept Obstet Gynecol

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“…6 Data were also analyzed according to FDA (Food and Drug Administration, USA) drug risk category and trimester wise drug use pattern. 7 Results were expressed in percentage and MeanSD±2.…”

Section: Methodsmentioning

confidence: 99%

Drug pattern use during pregnancy: a prospective study at tertiary care teaching hospital

Savitha¹,

Sarita²,

Gumma³

2016

Int J Basic Clin Pharmacol

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“…However, the authors concluded that the data collected, despite the limitations, were relevant to assessing risks to children's health. In an earlier assessment focused on risk of developmental toxicity (teratogenicity), the concordance of animal and human data was reviewed for 38 drugs reported to be developmental toxicants in humans, and 165 drugs reported not to produce developmental toxicity [37]. The results of the assessment showed that of 38 drugs identified as human teratogens, 37 were positive in at least one animal species, and 29 were positive in more than one species.…”

Section: Reproductive and Developmental Toxicity Testingmentioning

confidence: 99%

Does The Standard Toxicological Testing Paradigm for Industrial Chemicals Apply to Screening for Children's Health Risks?

Plunkett¹,

Becker²

2008

TOTOXIJ

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Abstract:Questions have been raised concerning whether standard toxicological testing paradigms for characterizing hazards are applicable for children. In this paper, the standard toxicological testing paradigm for industrial chemicals 1 is examined. The analysis includes examination of the basic principles and elements of hazard characterization methodology based on animal toxicity data, examination of the characteristics of the standard toxicity tests that apply to assessing hazards of industrial chemicals to children's health, and an appraisal of specific industrial chemical hazard characterizations developed by USEPA covering more than 200 substances (High Production Volume (HPV) Challenge datasets 2 ) with regard to their relevancy for use in screening for potential risks to children's health. We conclude that the standard toxicity tests used for industrial chemicals that comprise the USEPA's HPV Challenge provide adequate information for developing screening-level hazard characterizations for children's health, and when coupled with child-specific exposure information should provide adequate screening-level risk evaluations for children.

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FDA Perspectives on the Use of Teratology Data for Human Risk Assessment

Cited by 19 publications

References 3 publications

A study of morbidity and drug utilization pattern in indoor patients of high risk pregnancy at tertiary care hospital

A study of morbidity and drug utilization pattern in indoor patients of high risk pregnancy at tertiary care hospital

Drug pattern use during pregnancy: a prospective study at tertiary care teaching hospital

Does The Standard Toxicological Testing Paradigm for Industrial Chemicals Apply to Screening for Children's Health Risks?

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