English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

In 2008, the world market experienced a troubled period with respect to reliability of the product heparin. In the United States and Europe, lots of non-fractionated heparin were fraudulently contaminated with oversulfated chondroitin, which resulted in death of hundreds of patients. Brazil was also affected by the problem of heparin, but in other way. In early 2008, after the abrupt withdrawal from the market of non-fractioned endovenous heparin of the Roche laboratory (Liquemine), the Brazilian Society of Cardiovascular Surgery (BSCVS) began to receive alarming increase in queries from cardiac surgeons from around the country about the appearance of complications with the use of other brands of heparin available in the domestic market. These reported complications mostly involved increased postoperative bleeding and appearance of vasoplegic syndrome. The mobilization of BSCVS began by contact with the Roche laboratory, that reaffirmed the decision to cease the production of endovenous Liquemine. This brand of heparin (manufactured from the intestinal mucosa of pigs) was used by almost all the services of Cardiovascular Surgery of the country and had great reliability. At the same time, the National Health Surveillance Agency (ANVISA) was notified and the appropriate actions were requested. Then, the BSCVS contacted directly the pharmaceutical companies that market the non-fractioned heparin sodium in Brazil. Eurofarm and Bérgamo laboratories manufacture injectable heparin sodium from raw material (bovine intestinal mucosa) provided by national companies. The analysis of these products, performed at the Connective Tissue Laboratory of the Federal University of Rio de Janeiro, and additional tests performed in laboratories of the Federal University of Paraná and Federal University of Santa Maria, Rio Grande do Sul, showed no evidence of contamination by oversulfated chondroitin in the product analyzed. It was noted that the quantity of low molecular weight heparin met the reference product specifications. However, based on this analysis, it was shown clear difference in potency of action between the nonfractionated heparins from different origins, bovine and porcine – the latter, as the case of Liquemine. The porcine heparins have greater power of action than the bovine ones, with need for dose adjustment and more accurate monitoring when there is change of the product, which may explain the complications observed when the Liquemine was withdrawn from the market [1]. It became obvious that, although safe for use, the heparins made from bovine intestine are not the ideal choice for cardiovascular surgery, unlike those heparins made with pig intestine. Due to the difference in power between the non-fractionated heparins both of bovine and porcine origin, the recommendation from BSCVS was that a more rigorous testing of activated coagulation time (ACT) during heart surgery should be performed in order to ensure that ideal levels of anticoagulation were being achieved. It was agreed that the pharmaceutical companies, with the support of the ANVISA and BSCVS, would develop the heparin derived from intestinal mucosa of pigs similar to the product Liquemine that was withdrawn from the market. Four national pharmaceutical companies Blausiegel, Bérgamo, Eurofarma and Cristália developed the product heparin, derived from pig intestines. Under quality tests, these porcine heparins showed chemical structure and activity similar to the product Liquemine as study performed at the Connective Tissue Laboratory of the Federal University of Rio de Janeiro, since the raw materials for domestic industries comes from the same chinese pharmaceutical company that provided such material for the company Roche. The Chinese pharmaceutical were inspected by the Food and Drug Administration (FDA) and the ANVISA, that certified the laboratories with the GMP/ BPF Good Manufacturing Practices certification. After long and detailed agreement with ANVISA and national pharmaceutical companies that market heparin in Brazil, BSCVS started a clinical study with those porcine heparins to be marketed in Brazil, with a protocol extensively discussed between the Parties, to ensure quality and standardization of the product to be introduced in the national market. The clinical study started is being performed in only one center to ensure uniformity of the procedure (Federal University of Campinas UNICAMP) and will provide clinical

A busca de soluções para o problema das heparinas no mercado nacional