Avandia (Rosiglitazone) To Be Taken Off The Market In Europe

Editor's Choice
Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 24 Sep 2010 - 6:00 PST


Avandia (rosiglitazone), and all diabetes medications that contain rosiglitazone will be taken off the market within the next few months, says the European Medicines Agency (EMA) which has recommended taking it off the market. Specifically, the following brands are involved - Avandia, Avandamet and Avaglim. Yesterday, the FDA (Food and Drug Administration, USA) severely restricted rosiglitazone use and ordered GlaxoSmithKline, the makers and sellers of the drug, to convene an independent group of scientists to re-check data on the drug's clinical trials.

Rosiglitazone is currently being taken by patients with diabetes Type 2 as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl).

The European Medicines Agency (EMA) says that patients who are taking these medications at the moment should see their clinician to discuss suitable alternatives. You should not stop your rosiglitazone-containing medications without first talking to your doctor, EMA stresses.

EMA has told doctors they should stop prescribing medications that contain rosiglitazone, while patients currently on such drugs should be "reviewed in a timely manner to amend their treatment."

The CHMP (the Agency's Agency's Committee for Medicinal Products for Human Use) started reviewing rosiglitazone in July of this year when new study data questioning the cardiovascular safety of the medication became available.

Since being authorized in 2000, rosiglitazone has been linked to fluid retention and a higher risk of heart failure - European authorities have been monitoring rosiglitazone's cardiovascular safety closely, EMA informs. The medication was limited in Europe to second-line treatment and contra-indicated in patients with heart failure or a history of it.

Study data that became available over the last three years has suggested a link between ischemic heart disease and rosiglitazone use, resulting in further restrictions in patients with ischemic heart disease.

In view of the already-existing restriction, plus recent study data, the Committee could not see how new measures could reduce cardiovascular risk. Committee members concluded that the benefits no longer outweigh the risks and recommended the drug be taken off the market completely.

In a press release, EMA wrote:

The suspension will remain in place unless the marketing authorization holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.

The Committee's recommendation now goes to the European Commission which will turn it into a legally binding decision.

Related article: "Avandia (rosiglitazone) Use To Be Severely Restricted" (About US FDA decision yesterday)

Source: European Medicines Agency (EMA)

Written by Christian Nordqvist


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