Houston Marketing Agency

Posted on December 09, 2011 by Admin
Houston Marketing Agency

Houston Marketing Agency

On September 23, 2010, both the European Medicines Agency and the US Food and Drug Administration announced decisions regarding the future use of the diabetes drug Avandia. The medication is being pulled off the market entirely in Europe and will have its use severely restricted in the United States.

Avandia, Rise and Fall

Avandia was introduced in 1999 and quickly became the most popular treatment for type II (adult onset) diabetes. However by 2007 concerns arose about serious side effects such as fluid retention leading to increased risk of heart attack, congestive heart failure and stroke. Women taking Avandia were also found to be at increased risk of arm and leg fracture.

The active ingredient in Avandia, Rosiglitazone, is also found in the medications known as Avandamet and Avandaryl in combination with other drugs.

New Regulations for the Use of Avandia

In the United States, patients currently taking Avandia are allowed to continue; however a patient will only be able to be newly prescribed if no other diabetes treatment works. The FDA announced that it will require the drug's manufacturer, GlaxoSmithKline (GSK), to institute a "restricted access program" in which doctors will have to show that no other medication has achieved the goal of blood sugar control in that particular patient. The patient will also have to formally acknowledge that he or she understands and accepts the risks involved.

There are a variety of other diabetes medications, including Actos, which is in the same chemical family as Avandia, thiazolidinediones, or TZDs. Other drugs include sulfonylureas (for example, Amaryl),meglitinides (for example, Prandin), biguanides (for example, Glucophage) and newer drugs such as Byetta, available by injection only.

In Europe, Avandia will no longer be marketed and its use will be phased out over the coming months. The European Medicines Agency recommends that doctors stop prescribing the drug and that they promptly reassess their patients who are under diabetes treatment for alternate therapy.