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Rosiglitazone and the need for a new drug safety agency

BMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.c5506 (Published 06 October 2010) Cite this as: BMJ 2010;341:c5506
  1. Silvio Garattini, director, Mario Negri Institute for Pharmacological Research, Milan,
  2. Vittorio Bertele’, head, drug regulatory policies laboratory, Mario Negri Institute
  1. silvio.garattini{at}marionegri.it

The recent news about the suspension of rosiglitazone, a blockbuster antidiabetes drug, is not reassuring.1 Once again a widely prescribed drug shows a degree of toxicity that should not have allowed it to remain on the market for so long. This is not an isolated case, because it follows in a short time similar concerns over cerivastatin, rofecoxib, rimonabant, and sibutramine, not forgetting the selective serotonin reuptake inhibitors. In addition, a further case is now on the table, concerning the relation between the use of bisphosphonates and cancer.2

At least in the case of sibutramine and rosiglitazone, awareness of the risk of adverse events had been shown in the European Medicines Agency’s request for large randomised trials to investigate possible cardiotoxicity. A trial of sibutramine was committed to in 2002 and the trial begun in January 2003, completed in November 2009, and published in September 2010,3 well after the drug had been …

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