Avandia Information and Frequently Asked Questions

What is Avandia?

Avandia is a thiazolidinedione drug that’s used to treat diabetics. Also known as rosiglitazone, Avandia acts to lower glucose and insulin concentration by sensitizing the fat cells of the fat tissue to these compounds. Specifically, Avandia acts on receptors known as PPARs (peroxisome proliferated-activated receptors). Avandia is used primarily to treat insulin resistance, but studies on the drug’s pharmacology suggest that it could also potentially benefit patients who have Alzheimer’s disease, ulcerative colitis, and general inflammation.

Who makes Avandia?

The mega drug manufacturer, GlaxoSmithKline, produces Avandia. At one point, the drug was Glaxo’s second biggest seller. For example, in 2006 US sales topped at $2.5 billion.

Adverse Effects

Reports of adverse effects of rosiglitazone dampened demand, and sales plummeted by more than 20% in 2007 from 2006 numbers.

Why do doctors prescribe anti-diabetic drugs like thiazolidinediones, sulfonylureas, and Metformin?

Type 2 diabetics suffer from blood sugar control problems. In many cases, patients do not respond well to their internally produced insulin.

  • In normal healthy individuals, the beta cells in the pancreas produce insulin in response to sugar and carbohydrates in the diet. Insulin helps to move that sugar into cells, where it can be burnt for fuel; and it also repackages sugar as glycogen for use for fuel later.
  • In diabetics, the insulin the body produces is not enough to control blood sugar. As a result, diabetics can experience both hyperglycemia (too much blood sugar in the blood) as well as hypoglycemia (not enough blood sugar). The complications of this metabolic disorder can lead to all sorts of problems – ranging from obesity to injuries to soft tissue.

Drugs like Avandia, Metformin (also known as Avandamet), and Avandaryl attempt to solve the crisis of diabetes in different ways. Avandia is an insulin sensitizing drug – meaning that it’s meant to biochemically improve the body’s ability to effectively utilize the insulin it produces.

Avandia Drug Recall Information

The anti-diabetes drug Avandia drug recall was recently implemented at the advice of the Food and Drug Administration (FDA). The FDA’s move followed a long internal policy battle.

In 2007, an Advisory Board for the FDA voted 8 to 7 to allow Avandia to stay on the market, despite studies that showed that the drug could increase risk for heart failure in certain patients. 
The government agency changed its tune following the publication of a Canadian study in 2009, which provided evidence that Avandia caused more cardiovascular problems than did a similar drug on the market, Actos, made by the drug manufacturer Takeda. The Canadian study suggested that Avandia might cause 500 additional heart attacks per month and 300 additional cases of heart failure a month – as compared to Actos. Avandia’s manufacturer, GlaxoSmithKline, has vigorously debated the implications of the 2009 Canadian study – as well as the implications of the earlier US study that linked Avandia to heart problems. According to a New York Times article, a Glaxo spokesperson said that the “scientific evidence simply does not establish that Avandia increases” risk for cardiovascular events.

The FDA’s Internal Committee struggled mightily with the decision about whether to pull Avandia from the market. According to another report, the Director of the Food and Drug Administration’s Drug Center, Dr. Janet Woodcock, confessed that opinions about what to do about Avandia abounded. As a result of the vigorous debate, an independent committee had to be assembled to determine whether the drug should be allowed to remain in the market. Sales of Glaxo’s anti-diabetes insulin sensitizing drug had been slumping since 2006 – the earlier US study linking Avandia with heart problems had eroded the drug’s popularity with pharmacists and physicians. Even still, the drug was a major moneymaker for GlaxoSmithKline, and the recall hit the manufacturer hard. The use of thiazolidinediones (TZDs) for the treatment of diabetes has come under fire from a host of different critics, who contend that the whole class of drugs may be inappropriate to use on diabetics, since TZDs appear to cause symptoms of metabolic syndrome in patients.

Side Effects of Avandia

GlaxoSmithKline, the manufacturer of Avandia, has hotly contested some of the drug’s side effects. In particular, Glaxo has debated the accusation that the anti-diabetic thiazolidinedione drug increases the likelihood that patients will suffer cardiovascular problems, including heart attacks and heart failure.

Some Avandia side effects are less controversial. Glaxo admits that people who take the drug can be predisposed to bone fractures – even when compared with controls on other kinds of anti-diabetic drugs, such as Glyburide, Metformin, and even other thiazolidinediones.

Avandia also seems to predispose people to a problem called macular edema, which can result in blindness. Vision problems may or may not result directly from the drug. Since diabetics are predisposed to problems like macular edema, it could be that the diabetes itself causes the vision problems. But the association between the drug and the eye damage was enough to urge the manufacturer to warn doctors to get patients off the drug at the first indication of vision issues. 

Avandia may lead to problems which include hyperglycemia, hypoglycemia, itching, dizziness/nausea, breathing problems, body rash, otolaryngeal swelling, weight gain, fatigue and torpor.

Other studies have linked thiazolidinediones (as a class) with side effects such as weight gain. 

TZDs (as thiazolidinediones are sometimes referred to) are also used to treatment psychiatric conditions, such as mood disorders and depression. Psychiatric studies investigating the side effects of TZDs have suggested that these drugs can predispose certain patients to develop problems like obesity and even type 2 diabetes, ironically.

The real $64,000 question (actually, it is a multi-billion dollar question) about Avandia is whether the drug increases the risk for heart disease.  It is possible to find studies that support both propositions: 

Studies linking Avandia and heart disease:

  • A May 2007 meta analysis suggested that Avandia did increase the risk of a heart attack significantly and also increased risk for cardiovascular disease.
  • In February 2010, an FDA Committee pulled the drug from the market due to renewed fears about the drug’s impact on heart health – stemming in part from a newer Canadian study that suggested the drug did elevate risk in a statistically significant way.

Studies contesting the Avandia and heart disease link:

  • An FDA panel in July 2007 found that Avandia did NOT increase risk for cardiovascular events as compared with other anti-diabetic drugs.
  • Furthermore, another study called the RECORD study (published in the British Medical Journal, The Lancet, in 2009) supported this idea that Avandia was no worse at driving cardiovascular events than other common diabetic and anti-diabetic drugs.

Hepatotoxicity. Evidence suggests that patients who have hepatic impairment can be at high risk of hepatotoxicity while on Avandia.

Avandia Alternatives: Info about Other Common Anti-Diabetic Drugs

Thanks to the 2/10 FDA recall of the drug Avandia (also known as rosiglitazone), thousands of sufferers of type 2 diabetes (in coordination with their physicians) will soon investigate replacement medications. Below is a partial list of common anti-diabetes drugs (other than Avandia), along with a brief discussion of theories behind why these drugs work. Please speak with your physician before changing anything about your medication or lifestyle.

  1. Sulfonylureas:
 This class of drug tries to get the pancreas to release more “endogenous insulin.” In other words, it stimulates the beta cells in the pancreas to create more insulin to help normalize blood sugar. You can find both so-called first generation and second-generation sulfonylureas on the market. The second-generation drugs tend to be more effective and tend to have fewer side effects.
  2. Insulin sensitizing agents: 
This is the class of anti-diabetic drug that Avandia belongs to. Biguanides, such as Buformin or Metformin (also known as Glucophage), drive muscle tissue to uptake glucose, thus lowering overall blood sugar. Metformin has been associated with weight loss and lower risk for diseases like obesity and metabolic syndrome. Another insulin sensitizing class is the Thiazolidinedione (TZD) class. In addition to rosiglitazone (also known as Avandia), the drug Actos (also known as Pioglitazone) is used as an anti-diabetic TZD.
  3. Starch digestion inhibitors:
 This class of anti-diabetic drug works to prevent the rapid digestion of starch and sugars in the intestine. The idea is that, if digestion can be slowed, blood sugar won’t be elevated as quickly, and diabetes can be more easily controlled.
  4. Drugs that mimic the effect of insulin
: Diabetics experience a metabolic dysfunction in which endogenous insulin (insulin produced by the body) is insufficient to control blood sugars in a healthy way. Insulin analog medications (along with exogenously produced insulin) may be useful for treating some patients.

Diabetes Background Conceptual Design.Our attorneys are available to help you from our offices across New York State and Vermont, with locations to serve you in: New York City, NY, White Plains, NY, Schenectady, NY, Albany, NY, Saratoga, NY, Plattsburgh, NY, Buffalo, NY, Rochester, NY, Manchester, VT and Burlington, VT. Call us any time at 1-800-LAW-1010 if you have any long-term medical issues as a result of using Avandia.