Aplasia Cutis Congenita and Other Anomalies Associated with Methimazole Exposure During Pregnancy

Rodríguez‐García, Cristina; González-Hernández, Sorahaya; Hernández‐Martín, Ángela; Pérez-Robayna, Nuria; Sánchez, Rosalba; Torrelo, Antonio

doi:10.1111/j.1525-1470.2011.01572.x

Cited by 25 publications

(21 citation statements)

References 14 publications

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“…While the in utero exposure to methimazole or propylthiouracil has been associated with aplasia cutis and a number of other congenital defects (Löllgen et al, 2011;Rodriguez-Garcia et al, 2011), an IARC evaluation found inadequate evidence in humans, but limited evidence (in the case of methimazole) and sufficient evidence (in the case of thiouracil, methylthiouracil and propylthiouracil) in experimental animals for carcinogenicity (IARC, 2001;EFSA 2008b).…”

Section: (B) Thyreostatsmentioning

confidence: 99%

Scientific Opinion on the public health hazards to be covered by inspection of meat from sheep and goats

2013

EFSA Journal

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A risk ranking process identified Toxoplasma gondii and pathogenic verocytotoxin-producing Escherichia coli (VTEC) as the most relevant biological hazards for meat inspection of sheep and goats. As these are not detected by traditional meat inspection, a meat safety assurance system using risk-based interventions was proposed. Further studies are required on T. gondii and pathogenic VTEC. If new information confirms these hazards as a high risk to public health from meat from sheep or goats, setting targets at carcass level should be considered. Other elements of the system are risk-categorisation of flocks/herds based on improved Food Chain Information (FCI), classification of abattoirs according to their capability to reduce faecal contamination, and use of improved process hygiene criteria. It is proposed to omit palpation and incision from post-mortem inspection in animals subjected to routine slaughter. For chemical hazards, dioxins and dioxin-like polychlorinated biphenyls were ranked as being of high potential concern. Monitoring programmes for chemical hazards should be more flexible and based on the risk of occurrence, taking into account FCI, which should be expanded to reflect the SUMMARYFollowing a request from the European Commission to the European Food Safety Authority (EFSA), the Panel on Biological Hazards (BIOHAZ) was asked to deliver a Scientific Opinion on the public health hazards to be covered by the inspection of meat from sheep and goats. The Panel was supported by the EFSA Panels on Contaminants in the Food Chain (CONTAM) and Animal Health and Welfare (AHAW) in the preparation of this Opinion. Briefly, the main risks for public health that should be addressed by meat inspection were identified and ranked; the strengths and weaknesses of the current meat inspection system were evaluated; recommendations were made for inspection methods fit for the purpose of meeting the overall objectives of meat inspection for hazards currently not covered by the meat inspection system; and recommendations for adaptations of inspection methods and/or frequencies of inspections that provide an equivalent level of protection were made. In addition, the implications for animal health and animal welfare of any changes proposed to current inspection methods were assessed.Sheep and goats were considered together, unless otherwise stated. Decision trees were developed and used for priority ranking of biological and chemical hazards present in meat from sheep and goats. For biological hazards the ranking was based on the magnitude of the human health impact, the severity of the disease in humans and the evidence supporting the role of meat from sheep and goats as a risk factor for disease in humans. The assessment was focused on the public health risks that may occur through the handling, preparation for consumption and/or consumption of meat from these species. The term 'priority' was considered more appropriate than 'risk' for categorizing the biological hazards associated with meat from small rumina...

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Section: (B) Thyreostatsmentioning

confidence: 99%

Scientific Opinion on the public health hazards to be covered by inspection of meat from sheep and goats

2013

EFSA Journal

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“…It induces skin changes in newborns of mothers treated with this drug during pregnancy (1,24,32). However, after local methimazole administration, a species-specific reaction to the is demonstrated.…”

Section: Discussionmentioning

confidence: 99%

“…The most frequently occurring complications of methimazole treatment are agranulocytosis, granulocytopenia, aplastic anaemia, thrombocytopenia, systemic lupus erythematosus, druginduced vasculitis, and toxic liver injury. The drug may cause biophysical skin disorders due to blocking the biosynthesis of thyroid hormones (5,32). Methimazole also significantly modulates the production of reactive oxygen species such as a superoxide anion (O -2 ), and stimulates the mechanisms of anti-free radical defence (11).…”

Section: Discussionmentioning

confidence: 99%

“…This medicine has been known for more than 60 years and used in humans despite numerous side effects. The most often observed dermatological complications are aplasia cutis congenita and dystrophic fingernails in children born by mothers treated with methimazole during pregnancy (1,24,32), as well as drug-induced vasculitis (42). No side effects were observed in patients with local treatment of i.e.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Biophysical parameters of rats’ skin after the administration of methimazole

Gołyński¹,

Szczepanik²,

Lutnicki³

et al. 2014

Bulletin of the Veterinary Institute in Pulawy

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The paper describes the influence of oral administration of methimazole on biophysical skin parameters. Wistar rats of different sex (220-260 g) were used in the experiment. Biophysical skin parameters, such as transepidermal water loss (TEWL), corneometry, and pH were examined at seven-day intervals. Significant changes in the parameters were observed on the 7 th d of methimazole administration. The changes were observed in both sex but males appeared to be less sensitive in that respect. Changes in the parameters in the females showed rapid mechanisms, which normalised transepidermal water loss and skin hydration, as well as restored skin barrier functions. TEWL, skin hydration, and skin pH measurements allow an early assessment of skin barrier dysfunction after administration of this drug.

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“…While the in utero exposure to methimazole or propylthiouracil has been associated with aplasia cutis and a number of other congenital defects (Löllgen et al, 2011;Rodriguez-Garcia et al, 2011), an evaluation by the International Agency for Research on Cancer (IARC) evaluation found inadequate evidence in humans, but limited evidence (in the case of methimazole) and sufficient evidence (in the case of thiouracil, methylthiouracil and propylthiouracil) in experimental animals for carcinogenicity (IARC, 2001;EFSA 2008b).…”

Section: (A) Dioxinsmentioning

confidence: 99%

Scientific Opinion on the public health hazards to be covered by inspection of meat (bovine animals)

2013

EFSA Journal

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A risk ranking process identified Salmonella spp. and pathogenic verocytotoxin-producing Escherichia coli (VTEC) as current high-priority biological hazards for meat inspection of bovine animals. As these hazards are not detected by traditional meat inspection, a meat safety assurance system for the farm-to-chilled carcass continuum using a risk-based approach was proposed. Key elements of the system are risk-categorisation of slaughter animals for high-priority biological hazards based on improved food chain information, as well as risk-categorisation of slaughterhouses according to their capability to control those hazards. Omission of palpation and incision during post-mortem inspection for animals subjected to routine slaughter may decrease spreading and cross-contamination with the high-priority biological hazards. For chemical hazards, dioxins and dioxin-like polychlorinated biphenyls were ranked as being of high potential concern; all other substances were SUMMARYFollowing a request from the European Commission, the EFSA Panel on Biological Hazards (BIOHAZ) was asked to deliver a Scientific Opinion on the public health hazards to be covered by inspection of meat from several animal species, with the contribution of the Panel on Contaminants in the Food Chain (CONTAM) and the Panel on Animal Health and Welfare (AHAW). Briefly, the main risks to public health that should be addressed by the meat inspection system were identified and ranked; the strengths and weaknesses of the current meat inspection system were evaluated; recommendations were made for inspection methods addressing hazards not covered by the current meat inspection system; and recommendations for adaptations of inspection methods and/or frequencies of inspection that provide an equivalent level of protection were made. In addition, the implications for animal health and animal welfare of any proposed changes to current inspection methods were assessed. This opinion covers the inspection of meat from bovine animals.The Terms of Reference from the European Commission requested two opinions, one covering bovine animals under six weeks old and the other covering bovine animals over six weeks old. It was determined that within a true risk-based meat inspection concept, it is not necessary to design and apply a separate meat inspection system for individual bovine species or farming systems or animal age categories. Rather, a universal meat inspection framework can be designed and applied that would allow risk categorisation of animals based on individual farm-related food chain information (FCI), which also includes farming system and animal age category components. Furthermore, the available data from the National Residue Control Programmes (NRCPs) do not readily discriminate between the two age groups. Therefore, the assessment did not differentiate between these two age groups in terms of biological hazards, chemical residues and contaminants, and subsequently a single opinion is provided.Decision trees were developed and used for pr...

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Aplasia Cutis Congenita and Other Anomalies Associated with Methimazole Exposure During Pregnancy

Cited by 25 publications

References 14 publications

Scientific Opinion on the public health hazards to be covered by inspection of meat from sheep and goats

Scientific Opinion on the public health hazards to be covered by inspection of meat from sheep and goats

Biophysical parameters of rats’ skin after the administration of methimazole

Scientific Opinion on the public health hazards to be covered by inspection of meat (bovine animals)

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