The Dangers of Avandia

Rosiglitazone, marketed under the name of Avandia and approved for use in 1999, is an oral drug that reduces glucose (sugar) in the blood. It is used by Type 2 diabetes patients and is in the thiazolidinedione class of anti-diabetic drugs. As with any drug, there are some possible dangers associated with its use.

Frequent Side Effects

When Avandia is used either alone or with the diabetes drug metformin, the following side effects have been seen:

  • Upper respiratory tract infection
  • Headache
  • Back pain
  • Hyperglycemia (elevated blood sugar)
  • Fatigue
  • Sinus infection
  • Diarrhea
  • Hypoglycemia (low blood sugar)
  • Weight gain

Less Frequent Side Effects

  • In some patients mild to moderate edema was found, which may lead to heart failure.
  • Anemia is also a danger for those patients who also take metformin.
  • Increased chance of bone fractures have occurred in women who have taken the drug for 4 to 6 years.
  • Some serious allergic reactions can occur, including rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

Who Should Not Take Avandia

Patients with Type 1 diabetes should not take Avandia, since the drug requires that the pancreas still produces insulin. Other conditions for which Avandia is contraindicated include:

  • Very high blood glucose (diabetic ketoacidosis)
  • Newly diagnosed or worsening heart failure
  • A history of liver disease or current active liver disease

Danger of Cardiovascular Events Discounted

In November 2013, the U.S. Food and Drug Administration (FDA) removed some of the restrictions regarding prescribing Avandia. The agency had restricted the use of the drug in 2010 because of trials that associated the drug with heart attacks. The drug was restricted to patients who were unable to otherwise control their diabetes.

A large study, Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD), was then conducted to study these events and determine whether they were actually a result of Avandia. The trial showed no higher risk of heart attack or death in patients being treated with Avandia compared to other diabetes drugs. As a result, the restrictions were lifted.

Sources:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376516.htm