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by Mark S. Senak
Eye On FDA



The FDA issued a press release on the issuance of a safety alert on Avandia on May 21. On May 23, the European Medicines Agency (EMEA) also released a statement on Avandia safety. I thought it interesting to compare the tone and tenor of the two statements:

EMEA - An article published in the New England Journal of Medicine (NEJM) has raised concern about a small increased risk of myocardial infarction and cardiovascular death in patients with type 2 diabetes treated with rosiglitazone. (Emphasis my own)

FDA - The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. (Emphasis my own)

EMEA - Patients are advised not to stop treatment with rosiglitazone and to discuss medication with their doctor at their next regular visit. (Emphasis my own)

FDA - Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes. (Emphasis my own)

EMEA - 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 ab out the risk of cardiac ischaemic events ... Some of the studies in the NEJM paper included patients who were not treated in line with the indication approved in the EU. Prescribers are reminded to adhere to the restrictions for use in patients with cardiac disease as set out in the product information. (Note the statement also includes the fact when approved in the EU, rosiglitazone was contraindicated in patients with a history of cardiac failure.)

FDA - The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individual using Avandia. The new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.

It is interesting to see the somewhat divergent approach in tone. The releases are not radically different, but there is a nuance of language that is interesting. The EMEA statement (half page) seems a bit more relaxed about the safety concern. The FDA, on the other hand (page and a half), seems to go to lengths to assert what the FDA is doing and will do - perhaps with some members of Congress in mind. It is also interesting to note that the FDA used the trade name while the EMEA used the generic name.

Given the differences in their respective approaches, consequently, it would be an interesting exercise to compare the approved EMEA label with the approved FDA label.


Source: EyeOnFDA.com



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