Avandia Linked to Heart Attacks

Avandia works by reducing insulin resistance and helping the body use the insulin it produces. Approximately 21 million Americans suffer from diabetes, a disease responsible for nearly 300,000 deaths every year. In 2006 almost four million people in the US took Avandia. This diabetes medication was designed to replace Rezulin, a similar drug that was pulled from the market in 2000 after studies revealed it causes severe liver failure. At that time, the FDA conducted studies to test the effects of Avandia and concluded it did not carry the same risks associated with Rezulin.

Now, ongoing evidence suggests that this popular diabetes drug can do a great deal of harm. Safety concerns and side effects that have been associated with Avandia include the following:

• hypersensitivity
• cardiac failure
• hepatic impairment
• macular oedema
• bone fracture

In addition to these serious side effects, several other risk factors associated with consuming Avandia include: weight gain, cold, cough, headache, inflammation of sinuses, back pain, swelling, fluid retention and cardiac arrest.

Heart Attack and Death

In May 2007 the FDA announced that information obtained from clinical trials demonstrated that Avandia has the potential to increase the possibility of heart attack by 43 percent and may increase fatalities from general heart disease by 64 percent. Reports have found an increase of heart problems and congestive heart failure in particular occurring as a result of using Avandia.

Bone Fractures

Recent studies have shown that the risk of bone fractures in patients taking Avandia may be almost twice that of those not prescribed the drug. For those who have been taking Avandia for more than two years, the risk of bone fracture is nearly tripled.

In April 2008 the Archives of Internal Medicine determined that patients who had been prescribed Avandia for at least twelve months were almost twice as likely to suffer a bone fracture as those who did not take the drug. More disturbingly, among patients who had treated their diabetes with Avandia for at least two years, bone-fracturing levels had almost tripled.

In another report, The Canadian Medical Association Journal determined that female patients undergoing long-term treatment could double their risk of bone fracture. The study reviewed 10 previous clinical trials, and for every 20 women in their 70s with type 2 diabetes who took the drugs for at least one year, one has a chance of suffering a fracture. In women in their mid-50s, the figure equals one fracture in every 55 women. That’s more than double the normal risk for those age groups.

Liver Failure

A study recently published in the journal Pharmacoepidemiology and Drug Safety (July 22, 2009) has reportedly found a link between the use of Avandia and a risk of liver failure. The study, conducted by researchers from the public advocacy group Public Citizen, found that 11 deaths due to liver failure were reported to the FDA in patients who used Avandia. Those deaths occurred between 1997 and 2006. Public Citizen notes that because of a low incidence of adverse event reporting to the FDA, the actual incidence of liver failure in Avandia patients is more likely around 1 in 44,000 patients.

Avandia History

On June 28, 2001 the FDA requested that GSK discontinue distribution of misleading informational materials that minimized the alleged risks of Avandia.

In April 2002, the FDA sent a letter to healthcare providers telling them of changes in the Avandia warning label that now would include the possibility of excess fluid retention and congestive heart failure.

In December 2002, the FDA again asked GSK to revise their warning label to include reports of unusual, rapid increases in weight.

In 2003, a study published in the September 9 issue of the Mayo Clinic Proceedings reported that congestive heart failure can occur in Avandia patients. Already known to cause fluid accumulation, Avandia is being discouraged from use amongst anyone with a history of congestive heart failure or chronic renal insufficiency.

A report in 2008 stated that a government-run diabetes trial involving 10,000 patients was halted 18 months early after a safety analysis revealed an increased risk of death in patients whose blood sugar levels dipped too low.

Avandia Lawsuits

The Wall Street Journal reported in June 2007 that a class-action shareholder lawsuit was filed against GlaxoSmithKline, arguing that the company failed to disclose the heart attack risk that may be associated with Avandia. One month previously, the New England Journal of Medicine published an analysis suggesting that Avandia increases the risk of heart attack. And Glaxo itself had already compiled a similar analysis, which also showed a potential danger. However, the findings weren't reflected on the US label, which is supposed to give a comprehensive review of the drug's risks.

Meanwhile, hundreds of drug safety cases are being filed against Avandia as a result of life-threatening side effects.

Although Avandia has repeatedly been in the spotlight for the controversy surrounding its use, it remains a blockbuster drug for manufacturer GlaxoSmithKline and it remains on the market. Researchers have determined that Avandia needs stronger warnings about potential side effects.