Some Facts about Avandia

Saturday, 09 June 2007
By Kholood F. Al-Rhamah

For almost a month now public discussion in the health and patient communities here in Saudi Arabia has been focused on the side effects and the dangerous possible outcomes using a drug called rosiglitazone or Avandia. So what is Avandia? What is it used for? What are its side effects? And what is the F.D.A. saying? What is Avandia?

Avandia is a medication used by patients diagnosed with type 2 diabetes. Its function is to keep their blood sugar level down to a manageable level. In the healthy body the blood sugar level is controlled by its natural supply of insulin, which moves sugar in to cells from the blood stream.

But in type 2 diabetes, the sugar gathering in the blood is sometimes slow because of the insulin shortage and because the body can't process it properly or naturally as it should. Avandia's function is to diminish the production of sugar in the blood and then help the body to use any existing amount of insulin sufficiently, but it does not increase the percentage of insulin in the body.

It is usually used as an aid to dieting, losing weight and exercising and taken on a fixed schedule. It is not to be used as a substitute to insulin, but as an aid to its functional use.

Side effects
In the F.D.A.'s (The US Food and Drug Administration) safety warning regarding Avandia issued May 21, 2007 they expressed their awareness of a potential dangerous side effect. "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.

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," a statement taken from the safety warning issued by the F.D.A..

The statement also mentioned that there is a risk to patients who switch from Avandia to other medications, therefore it is necessary for every patient to discuss their medical condition with the specialist physician who is aware of this newly published safety information.

Aside from the warning by the F.D.A. that Avandia is associated with a significantly high risk of heart attack and heart-related deaths, it has its other side effects. For instance, function effects, weight gain, edema, anemia, low blood pressure, elevated lipid levels, and possible progesterone level changes.

What has been said about Avandia from doctors and officials?
Doctors take the warning seriously. Dr. Kafiyul Rahman an Internist at Jeddah's Samira Poly Clinic said that it is a very good medicine, but it should be taken only under the supervision of the specialist doctor. "Most patients prescribed Avandia leave themselves in danger because patients don't return to the doctor's for the medical follow-up and check on the medication's success and possible side effects. It requires medical supervision," said Dr. Rahman.

"Most patients with diabetes have a heart condition and they should not stop the medication unless their body has the ability to stop the drug use, that's what doctors can help evaluate," he added.

The official spokesperson of the Ministry of Health, Riyadh, Dr. Khaled Mohammed Marghalany spoke to an Arabic daily about the published study recently and the F.D.A. safety warning on Avandia.

"The paradoxical study that has been published recently on the dangerous effects of Avandia causes public concern," he indicated in a press conference where the F.D.A. spoke to the awareness of side effects of the drug. Further stating, stopping or changing medication should be under the supervision and consultation of a specialist.

However, "publishing this information does not mean advising doctors not to prescribe the medicine, nor stop patients from using it, but for both doctors and patients to discuss every condition separately," said Dr. Marghalany.