Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil

Vianna, Fernanda Sales Luiz; Oliveira, Marcelo Zagonel de; Sanseverino, Maria Teresa Vieira; Morelo, Elaine F.; Neto, Dácio de Lyra Rabello; López-Camelo, Jorge S.; Camey, Suzi Alves; Schüler‐Faccini, Lavínia

doi:10.1016/j.reprotox.2015.03.007

Cited by 18 publications

(21 citation statements)

References 24 publications

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“…Thalidomide is a drug indicated for the treatment of erythema nodosum leprosum (ENL), and more recently, to a number of different medical conditions, due to its immunomodulatory properties (Vianna et al , 2011, 2015; Kim and Scialli, 2011;). The Latin-American Collaborative Study of Congenital Malformations (ECLAMC) reported 34 thalidomide embryopathy cases in South America from the 1960s to 1990s, of which 33 where in Brazil.…”

Section: Brazilian Cases Of Teratogenesismentioning

confidence: 99%

“…The state of São Paulo leads the thalidomide drug distribution rates (5,889,210 thalidomide tablets), followed by Minas Gerais and Rio de Janeiro, from 2005 to 2010. In this period, there were 2,802 reported cases of limb reduction defects, with 192 cases compatible with a thalidomide embryopathy phenotype (TEP) (Vianna et al , 2015). This demonstrates the seriousness of this public health issue.…”

Section: Brazilian Cases Of Teratogenesismentioning

confidence: 99%

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Teratogens: a public health issue – a Brazilian overview

et al. 2017

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Congenital anomalies are already the second cause of infant mortality in Brazil, as in many other middle-income countries in Latin America. Birth defects are a result of both genetic and environmental factors, but a multifactorial etiology has been more frequently observed. Here, we address the environmental causes of birth defects – or teratogens – as a public health issue and present their mechanisms of action, categories and their respective maternal-fetal deleterious effects. We also present a survey from 2008 to 2013 of Brazilian cases involving congenital anomalies (annual average of 20,205), fetal deaths (annual average of 1,530), infant hospitalizations (annual average of 82,452), number of deaths of hospitalized infants (annual average of 2,175), and the average cost of hospitalizations (annual cost of $7,758). Moreover, we report on Brazilian cases of teratogenesis due to the recent Zika virus infection, and to the use of misoprostol, thalidomide, alcohol and illicit drugs. Special attention has been given to the Zika virus infection, now proven to be responsible for the microcephaly outbreak in Brazil, with 8,039 cases under investigation (from October 2015 to June 2016). From those cases, 1,616 were confirmed and 324 deaths occurred due to microcephaly complications or alterations on the central nervous system. Congenital anomalies impact life quality and raise costs in specialized care, justifying the classification of teratogens as a public health issue.

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Section: Brazilian Cases Of Teratogenesismentioning

confidence: 99%

Section: Brazilian Cases Of Teratogenesismentioning

confidence: 99%

Teratogens: a public health issue – a Brazilian overview

et al. 2017

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“…In total, 51 documents met the inclusion criteria (Fig 1). This included 23 articles published in scientific journals [1,8,9,11,[23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41], 3 postgraduate studies sensu stricto [3,4,10], 6 protocols, manuals, or books published by the MoH and WHO [18][19][20][42][43][44], 1 epidemiological bulletin [45], 13 laws [17,[46][47][48][49][50][51][52][53][54][55][56][57], data from 2 databases of the MoH [58,59], and content from 3 internet sites with the domain ".org"…”

Section: Methodsmentioning

confidence: 99%

“…This same study was replicated for all births in the country between 2005 and 2010, using data on the prevalence of leprosy and the distribution of thalidomide in the same period. There was a direct correlation between the amount of thalidomide distributed and the number of children born with TEP, suggesting the need for emergency education on the safe use of the drug [30].…”

Section: Embryopathy Cases Due To Thalidomide Use During Pregnancymentioning

confidence: 99%

The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review

2020

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The drug thalidomide has resurged in the world market under restrictive conditions for marketing and use. In Brazil, there are still cases of pregnant women using thalidomide even after the implementation of laws that regulate the control of use (Law No. 10.651/2003 and Collegiate Board Resolution No. 11/2011). The objective of this study was to discuss the control of thalidomide use in Brazil, based on a scoping review of the scientific literature, documents, and data from the Ministry of Health. A total of 51 studies and documents related to the following subthemes were selected: (1) organization of access and use of thalidomide in the health system; (2) epidemiological and population characteristics of people affected by leprosy; and (3) occurrence of pregnancy and cases of embryopathy with the use of thalidomide. The results showed that Brazil has no unified information database about thalidomide patients. Furthermore, there is inconsistency in the accreditation of public health centers that dispense this medicine, in a country that has a high consumption of thalidomide in the Unified Health System. A large part of this amount of dispensed medicine is intended for the treatment of erythema nodosum leprosum, mainly in the North, Northeast, and Central-West regions of the country, which are endemic for leprosy. This disease is the only one among the clinical indications of the medicine approved in Brazil that does not have a Clinical Protocol and Therapeutic Guidelines. The control of thalidomide use in Brazil presents historical regulatory failures. These are currently linked to the organization and structure of primary healthcare in the country, as well as to the lack of leadership of the Ministry of Health and National Health Surveillance Agency when it comes to managing the process of control of this use.

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“…9-12 Now, CRBN is known to significantly play a role in ubiquitin-mediated protein degradation as proportions and the prescription is difficult to robustly control, new TE babies are still potentially born. 4,5 It is widely believed that the antiangiogenic action of thalidomide is responsible for the majority of TE phenotypes, including phocolemia. 1,6 This action might cause as-yet-unknown congenital vascular anomalies.…”

Section: Article P 2364mentioning

confidence: 99%

A Lesson From the Thalidomide Tragedy　― <i>The Past Is Never Dead. It’s Not Even Past.</i> William Faulkner, From “<i>Requiem for a Nun</i>” ―

Yashiro

Miyagawa

Sawa

2018

Circ J

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antiangiogenic, immunomodulatory, and antineoplastic (Figure 1). These pharmacological actions are beneficial for treating erythema nodosum leprosum and multiple myeloma, 1 and it is now used to treat them. In industrialized countries, its use is carefully monitored under strict guidelines such as "THALOMID Risk Evaluation and Mitigation Strategy" in USA (http://www.thalomidrems. com/about.html) and "Thalidomide Education and Risk Management System" in Japan (http://www.fujimoto-pharm. co.jp/jp/iyakuhin/thalido/pdf/TERMS-5.pdf). However, we already know that TE is not a past problem. 1,3 In 1996, it was reported that TE had still been occurring in South America since the early 1960s. That report revealed that a total of 34 patients with TE were confirmed to be born between 1969 and the 1990 s. All of them, 33 cases in Brazil and 1 in Argentina, were related to leprosy treatment. In developing countries, where leprosy is at endemic

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Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil

Cited by 18 publications

References 24 publications

Teratogens: a public health issue – a Brazilian overview

Teratogens: a public health issue – a Brazilian overview

The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review

A Lesson From the Thalidomide Tragedy　― <i>The Past Is Never Dead. It’s Not Even Past.</i> William Faulkner, From “<i>Requiem for a Nun</i>” ―

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Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil

Cited by 18 publications

References 24 publications

Teratogens: a public health issue – a Brazilian overview

Teratogens: a public health issue – a Brazilian overview

The organization, weaknesses, and challenges of the control of thalidomide in Brazil: A review

A Lesson From the Thalidomide Tragedy ― <i>The Past Is Never Dead. It’s Not Even Past.</i> William Faulkner, From “<i>Requiem for a Nun</i>” ―

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A Lesson From the Thalidomide Tragedy　― <i>The Past Is Never Dead. It’s Not Even Past.</i> William Faulkner, From “<i>Requiem for a Nun</i>” ―