Heart attack risk at Avandia Diabetes Center

Increased risk of heart attack in diabetes Agent: The European Medicines Agency EMA has suspended the approval of the diabetes drug Avandia.

The drug "Avandia", conceived for diabetics, is to be taken from the European medicines market because of an increased risk of heart attack. The drug has been suspected for some time to increase the risk of heart attacks.

Studies and warnings from health experts have been enough in recent times. Now the European Medicines Agency (EMA) sees itself as responsible to act. The drug Avandia of the pharmaceutical company "GlaxoSmithKline" with the active ingredient "Rosiglitazone" will be removed in the next few months from pharmacies. As justification, the EU authority stated that the adverse effects exceed the benefit of the drug. Here there is no adequate relationship for the patient. All national drug agencies and authorities are subordinate to the instructions of the EU authority, so this applies to all member states of the European Community.

In advance, the US Food and Drug Administration (FDA) had already decided on significant restrictions. The drug should only be prescribed by doctors, if no alternative preparations are available. However, the US authorities renounced an absolute ban at the time. British health authorities responded with drastic measures in early September and ordered a stop to sell Avandia. According to media reports, the remedy in patients should lead to an increased stroke and heart attack risk.

Also on the index are comparison medications, which also contain the active ingredient rosiglitazone. These are next to Avandia, Avandamet and Avaglim. These medicines should also disappear from the pharmacy trade within a few months. However, diabetics who are taking this medicine are urged not to dispense the administered drug on their own. Patients should first consult with their attending physician for possible alternatives. Otherwise, health-threatening consequences could occur for the person concerned.

The active substance rosiglitazone is intended to stabilize the blood sugar content in type II diabetes. But already two years ago, there should have been clinical evidence that the drug rosiglitazone could damage the heart. According to media reports, the pharmaceutical company at that time referred to the incompleteness of the study results. But exactly this process accuses the group of numerous patients. The corporation responded to clues too late, the accusation of American patients.

For the British pharmaceutical manufacturer "GlaxoSmithKline" the decision of the EU authority should be a bitter financial setback. Alone with this in recent years quite successful drug Avandia, the group had earned millions of profits. According to estimates, the drug should have generated around 900 million euros in sales last year. Even the pharmaceutical company itself was already reacting, it was announced that they would not continue to promote the funds. According to a press release from the group, the medical effect of the substance "rosiglitazone" for "suitable patients" persists. The drug continues to be an "important option" in the treatment of some type 2 diabetes patients. They want to work closely with the FDA and EMA authorities. In the US, all rosiglitazone-containing medicines remain available on the drug market. However, the preparations are provided with additional safety instructions and restrictions on use. In addition, the drugs should only be used if no other medicines are available for the individual patient. The FDA is committed to a risk assessment and program of additional measures to ensure safe use of the drug.

The risk of the drug, however, is already well known for a long time. A US study by Cleveland Clinic scientist Steve Nissen in 2007 found that there was an increased risk of heart attack in over 40 percent of diabetic patients. The findings were published in the "New England Journal of Medicine" and already caused a great public debate. Based on these findings, the US Food and Drug Administration (FDA) has warned that appropriate warnings should be placed on the Avandia drug. In response, even then, Avandia's sales worldwide were up 38 percent. About 15 days later, the drugmaker released interim results from a long-term study that looked at heart attack risk. It also commented on the Cleveland study, arguing that the data was insufficient to actually assess whether Avandia increased the risk of heart attack. However, the parties were accused at that time that the group would have known prior to publication by an indiscretion of the Cleveland study and can prepare accordingly. (sb, 25.09.2010)

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Diabetes drug is taken off the market

Credit: TommyS