Increased risk of heart attack with diabetes drugs: The European Medicines Agency EMA has suspended the approval of the diabetes drug Avandia.
The drug “Avandia”, designed for diabetics, is to be withdrawn from the European pharmaceutical market due to an increased risk of heart attack. The drug has long been suspected of increasing the risk of heart attacks.
There have been enough studies and warnings from health experts recently. Now the European European Medicines Agency (EMA) sees it as its responsibility to act. The drug Avandia from the pharmaceutical company "GlaxoSmithKline" with the active ingredient "Rosiglitazone" is to be removed from the pharmacies in the next few months. As a reason, the EU authority stated that the undesirable side effects outweigh the benefits of the drug. There is no longer an appropriate relationship for the patient. All national drug agencies and authorities are subordinate to the instructions of the EU authority, so that this applies to all member states of the European Community.
The US Food and Drug Administration (FDA) had previously decided on significant restrictions. The drug should only be prescribed by doctors if no alternative preparations are available. At the time, however, the US authority waived an absolute ban. British health authorities had already taken drastic measures in early September and had ordered that Avandia be stopped selling. According to media reports, the drug is said to lead to increased stroke and heart attack risk in patients.
Comparative drugs that also contain the active ingredient rosiglitazone should also be on the index. These are alongside Avandia, Avandamet and Avaglim. These drugs should also disappear from the pharmacy trade within a few months. However, diabetics who take this medication are advised not to discontinue the administered drug on their own. Patients should first consult with their treating physician for possible alternatives. Otherwise, health consequences could occur for the person concerned.
The active ingredient rosiglitazone is said to stabilize the blood sugar level in type II diabetes. However, two years ago there should have been clinical evidence that the active ingredient rosiglitazone could damage the heart. At the time, according to media reports, the pharmaceutical company referred to the incompleteness of the study results. It is precisely this process that the company accuses numerous patients of. The corporation had reacted too late to information, according to American patients.
For the British pharmaceutical manufacturer "GlaxoSmithKline", the decision by the EU authority is likely to be a bitter financial setback. With this drug, Avandia, which has been quite successful in recent years, the company had made millions of profits. According to estimates, the preparation should have generated sales of around 900 million euros last year. The pharmaceutical company itself has already responded, and it has been announced that it will no longer advertise the product. According to a press release from the group, the medical effect of the substance "rosiglitazone" for "suitable patients" is still believed. The drug is still an "important option" in the treatment of some type 2 diabetes patients. The company plans to work closely with the FDA and EMA authorities. In the United States, all drugs containing rosiglitazone 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 drugs are available for the individual patient. The FDA is committed to risk assessment and a program of additional measures to ensure the safe use of the drug.
However, the risk of the drug has been known for a long time. In 2007, a US study by scientist Steve Nissen from the Cleveland Clinic found that there was an increased risk of heart attack in over 40 percent of diabetes patients. The results were published in the “New England Journal of Medicine” and caused a great public debate even then. Based on these results, the US agency FDA decided that appropriate warnings should be placed on the Avandia drug. In response, Avandia's sales were already 38 percent worldwide. About 15 days later, the pharmaceutical company published interim results of a long-term study that examined the risk of heart attack. It also commented on the Cleveland study and argued that the data were insufficient to actually assess whether Avandia increased the risk of a heart attack. At the time, however, the parties involved were accused of knowing the Cleveland study even before it was published, and of being able to prepare accordingly. (sb, 09/25/2010)
Diabetes drug is being withdrawn from the market
Photo credit: tommyS / pixelio.de