A EMEA - agência européia equivalente ao FDA americano e ANVISA brasileiro - manifestou-se sobre o caso Avandia, informando que não há surpresa no publicado e, que o medicamento encontra-se sobre vigilância da agência, que reconhece o aumento de doença isquêmica cardíaca.
Reproduzo, a seguir , em negrito a declaração da EMEA:
When rosiglitazone was first authorised in the EU in 2000, it was contraindicated in patients with a history of cardiac failure. Since then, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has kept rosiglitazone under close surveillance for cardiovascular effects (cardiac failure and other cardiac disorders including myocardial infarction). The majority of the studies included in the NEJM paper have already been assessed by the CHMP. The EU product information was updated in September 2006 with information about the risk of cardiac ischaemic events.
Pergunto porque a agência não se manifestou anteriormente?
O FDA também se manifestou com declaração contraditória onde ora afirma que novas análises do estudo DREAM e de outro em andamento não revelaram risco (o DREAM não tinha revelado risco, não entendi essa menção) ou então declara que já mudara a bula do Avandia devido ao seguinte fato relatado pela própria empresa
Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.
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