Pharmacy Daily | EU, FDA act on Avandia

YESTERDAY The European Medicines Agency’s Committee on Medical Products for Human Use withdrew its support for the secondline diabetes drug Avandia (rosiglitazone), saying its benefits no longer outweighed its risks. Prior to its recommendation that the EU suspend its marketing approval for Avandia, the Committee looked at new clinical trials and observational studies as well as meta-analyses of existing studies into rosiglitazone’s risk vs reward profile and found that overall rosiglitazone “significantly increased users risk of cardiovascular events and stroke”. According to the European Medicines Agency, when it first approved rosiglitazone there was an awareness that the drug could cause fluid retention and had the potential to increase the risk of heart failure, and as such it had always kept the medication under “close review”. Prior to its full suspension, rosiglitazone had recently been restricted in patients with ischaemic heart disease after studies data showed that it increased the risk of heart disease. In announcing its decision to suspend the drug fully, the Committee said it could not find any additional measures that would reduce the drug’s cardiovascular risk, and therefore its risk profile was too great. As a result of the recommendation, Avandia as well as two other rosiglitazone containing antidiabetics medications, Avandamet and Avaglim, will cease to be available in Europe within the next few months. The suspension will remain in place unless the drug;s manufacturer GlaxoSmithKline can provide “convincing data” that identifies a group of patients “in whom the benefits of the medicines outweigh their risks”. Patients currently using the suspended drugs are now being advised to seek an alternative therapy from their doctor, whilst European GPs are being told to review the treatment of patients currently taking the rosiglitazone medications. MEANWHILE across the Atlantic the US Food and Drug Administration also announced yesterday that it will significantly restrict the use of Avandia to patients with Type 2 diabetes who cannot control their diabetes on other medications - but has not completely withdrawn the drug. Again, the Agency’s decision comes after consideration of new data which suggested an elevated risk of cardiovascular events in patients treated with Avandia. “The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret Hamburg. “We are seeking to strike the right balance to support clinical care,” she added. The decision now means that GSK must develop a restricted access program for Avandia under a “risk evaluation and mitigation strategy” whereby the drug will only be available to new patients if they do not receive adequate glucose control on other medications and are unable to take Actos (pioglitazone). Under the new scheme US patients currently taking Avandia will be able to continue using the drug if they choose too. In addition to its new restrictions, the FDA also yesterday ordered GSK to convene an independent group of scientists to review key aspects of its own Review study which looked into the cardiovascular safety of Avandia compared to standard diabetes drug, and has also halted GSK’s current TIDE trial which was comparing Avandia against Actos and other standard diabetes medications. FURTHERMORE GSK has this morning released a statement to the Australian industry, saying that based on the totality of the data available it believes that Avandia is “an important treatment option for patients with type 2 diabetes”. Although the TGA has not as yet, issued any suspensions or restrictions against the drug, GSK has been quick to reassure patients and GPs, saying that none of the 15,000 patients currently on the drug in Australia should suddenly stop taking it, and should they have any concerns to consult their general practitioner.

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