Alerta De Seguridad para Ultra Corega ANTI-PARTICULATE SEALANT - Registered at Anvisa under the number 80141610010.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Glaxo Smith Kline Brazil Ltda (GSK Consumer Healthcare Brasil) has informed Anvisa that, according to research from the medical literature, the inadequate use of zinc-containing dental prosthesis fixatives over the years may lead to the development of neurological symptoms. The cases reported in the recent medical literature (Hedera, 2009; Nations, 2008) are associated with the consumption of 2 or 3 tubes per week, for a total of 330mg, that is, more than 10 times the maximum tolerated intake. The symptoms reported may include numbness, tingling or weakness in the arms and legs, difficulty walking and balance, and blood problems (such as anemia). In Brazil, in the company's database, there are no reports of events of this nature. Likewise, in Anvisa's databases there are no notifications associated with said product. According to GSK Consumer Healthcare Brazil, the reports mentioned are almost exclusively restricted to the United States (n = 409), where the product has been marketed since 1995, with an increase in cases in 2009 (n = 365), compared to a total of 416 reports of these adverse events in the world. The cases reported in the recent medical literature (Hedera 2009, Nations 2008) are associated with the consumption of 2 or 3 tubes weekly, with doses of 330mg, more than 10 times the maximum tolerated intake, for a period of more than 7 years. In Brazil, the Ultra Corega product ANTI-PARTICULATES has been marketed for a year and there are no reports to the company of serious adverse events related to the excessive and prolonged use of the zinc-containing prosthesis fixative. In addition, the product formula registered in Brazil contains 17% less zinc than the options available in the US market and the commercial presentations are tubes of 40g and 20g, therefore smaller than the American version of 68g. ANVISA's Technovigilance Unit is following up on this case. #### TERMINATION OF THE SHARING - 10/30/2010 - On time - The company confirms the destruction of its remaining stock through certificates HTZ0003185 / 2010 and HTZ0003186 / 2010, issued by the company HAZTEC Tecnologia e Planejamento Ambiental S / A and the Closing Letter of Marketing of the Product, as agreed in Meeting in this Agency on 02/23/2010. ####